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First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04993443
Recruitment Status : Recruiting
First Posted : August 6, 2021
Last Update Posted : September 5, 2021
Sponsor:
Collaborator:
Shanghai Novamab Biopharmaceuticals Co. Ltd.
Information provided by (Responsible Party):
Syneos Health

Brief Summary:

This is Phase I first-in-human trial evaluating the safety, tolerability, immunogenicity, and pharmacogenomics of LQ036 via inhalation and IV infusion.

The study will be divided into 3 parts: Single Ascending Dose, Multiple Ascending Dose, and Intra Venous with a target of 88 healthy volunteers.


Condition or disease Intervention/treatment Phase
Asthma Drug: LQ036 Other: Matching Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single and Multiple-dose Escalation First-in-Human Study Evaluating the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036 Administered Via Inhalation and IV Infusion in Healthy Subjects
Estimated Study Start Date : September 6, 2021
Estimated Primary Completion Date : February 3, 2022
Estimated Study Completion Date : February 4, 2022

Arm Intervention/treatment
Experimental: Active Comparator: Drug :LQ036
Experimental, Single and Multiple Oral escalating dose
Drug: LQ036
For Each part of the study, a staggered dosing schedule may be used for the first dose level, in each cohort including 2 sentinel subjects (1 active and 1 placebo) initiating dosing first and the remaining 6 subjects initiating dosing no sooner than the next day. Cohorts will be dosed sequentially in an ascending fashion. Each study part (A, B and C) will be completed sequentially, but with partial overlapping. Part B and C may only be initiated after review of the safety, tolerability, and PK data following dosing of the SAD Cohort 3 or 4.

Placebo Comparator: Placebo Comparator: Matching Placebo for LQ036
Matching Placebo for LQ036: Matching Placebo
Other: Matching Placebo
Matching Placebo for LQ036: Matching Placebo
Other Name: Matching Placebo for LQ036




Primary Outcome Measures :
  1. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 weeks. ]
    Assessment of outcome of Adverse events

  2. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 1 Month ]

    Abnormal blood pressure

    Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1.

    Part B: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.


  3. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 1 Month ]

    Abnormal pulse rate

    Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1.

    Part B: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.


  4. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 1 Month ]

    Abnormal respiratory rate

    Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1.

    Part B: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.


  5. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 1 Month ]

    Abnormal Tympanic Temperature

    Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1.

    Part B: At check-in (Day -1), on Day 1: pre-dose, and 1, 2, 4, 6, 8, and 12 hours-post first dose, pre-dose and 2 and 6 hours post-dose on Days 2 to 10, and on Days 11, 12, 13, 15±1, 22±1, and 29±1.


  6. To assess changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables. [ Time Frame: Up to 1 Month ]

    Change in electrocardiograms (ECGs).

    Part A and C: At check-in (Day -1), pre-dose (Day 1), and 1, 2, 8, and 24 (Day 2) hours post-dose, at discharge (Day 3), and on Days 8±1, 15±1, and 22±1.

    Part B: At check-in (Day -1), and pre-dose and 1, 2, and 8 hours post-dose on Days 1 to 12, and at discharge (Day 13), and on Days 15±1, 22±1, and 29±1.


  7. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]

    Assessment of abnormal clinical laboratory tests (hemoglobin)

    Part B: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).

    Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).


  8. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]

    Assessment of abnormal clinical laboratory tests (hematocrit)

    Part B: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).

    Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).


  9. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]

    Assessment of abnormal clinical laboratory tests (mean corpuscular volume)

    Part B: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).

    Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).


  10. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]

    Assessment of abnormal clinical laboratory tests (leukocyte counts)

    Part B: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).

    Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).


  11. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]

    Assessment of abnormal clinical laboratory tests (platelet count)

    Part B: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).

    Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).


  12. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]

    Assessment of abnormal clinical laboratory tests (Urea)

    Part B: At check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).

    Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), on Day 8±1, and at study exit (Day 29±1).


  13. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]
    Assessment of abnormal clinical laboratory tests (creatinine)

  14. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]
    Assessment of abnormal clinical laboratory tests (alkaline phosphatase)

  15. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]
    Assessment of abnormal clinical laboratory tests (glucose)

  16. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]
    Assessment of abnormal clinical laboratory tests (alanine aminotransferase (ALT))

  17. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]
    Assessment of abnormal clinical laboratory tests (aspartate amino transferase (AST))

  18. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]
    Assessment of abnormal clinical laboratory tests (total bilirubin)

  19. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]
    Assessment of abnormal clinical laboratory tests (sodium)

  20. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]
    Assessment of abnormal clinical laboratory tests (potassium)

  21. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]
    Assessment of abnormal clinical laboratory tests (chloride)

  22. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]
    Assessment of abnormal clinical laboratory tests (calcium)

  23. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]
    Assessment of abnormal clinical laboratory tests (total proteins)

  24. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]
    Assessment of abnormal clinical laboratory tests (Phosphorus)

  25. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]
    Assessment of abnormal clinical laboratory tests (albumin)

  26. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]

    Assessment of abnormal clinical laboratory tests (Coagulation test (aPTT (Activated partial thromboplastin time) and INR (International Normalized Ratio))

    Part B: At screening and at study exit (Day 36±1)

    Part A and C: At screening and at study exit (Day 29±1).


  27. To evaluate the safety of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 5 Weeks ]

    Assessment of abnormal clinical laboratory tests (Urine macroscopic examination, pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, nitrite, urobilinogen, and leukocytes)

    Part B: At screening, at check-in (Day -1), on Days 2 and 7, at discharge (Day 13), and at study exit (Day 36±1).

    Part A and C: At screening, at check-in (Day -1), on Day 2, at discharge (Day 3), and at study exit (Day 29±1).


  28. To evaluate the tolerability of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to two weeks ]

    Local tolerability (oropharyngeal) assessment (Part A) and (injection site) assessment (Part C): The area where the study drug was administered will be monitored by study personnel throughout the study for any signs of local reactions such as swelling or redness.

    Time frame: pre-dose, Day 1, 2, 4, 8, and 24 hours post-dose, and at Day 3.

    Local tolerability (oropharyngeal) assessment (Part B): The area where the study drug was administered will be monitored by study personnel throughout the study for any signs of local reactions such as swelling or redness.

    Time frame: pre-dose (as well as 1, 2, and 4 hours post-dose on Days 1, 3, 5, 8, and 10, 11, and at Day 13.


  29. To evaluate the immunogenicity of single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 3 Weeks ]

    Immunogenicity data that will be evaluated include Anti-Drug Antibody test sampling (ADA).

    Parts A and C: A total of 5 blood samples will be taken for ADA assessment: at pre-dose (Day 1), and on Days 8±1, 15±1, and 22±1, and at study exit (Day 29±1)

    Part B: A total of 6 blood samples will be taken for ADA assessment: at pre-dose (Day 1), and on Days 8±1, 15±1, 22±1, 29±1, and at study exit (Day 36±1)


  30. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    AUC0-t: Area under the concentration-time curve from time zero until the last observed concentration

  31. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    AUC0-inf: Area under the concentration-time curve from time zero to infinity (extrapolated)

  32. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    Residual area: Percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as [1 - (AUC0-t/AUC0-inf)] x 100

  33. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    AUC0-24: Area under the concentration-time curve from time zero to 24 hours post-dose.

  34. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    AUC0-τ: Area under the concentration-time curve for one dosing interval (τ) at steady-state. In this study τ = 24 hours (AUC0-24)

  35. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    AUC0-72: Area under the concentration-time curve from time zero to 72 hours post-dose.

  36. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    Cmax: Maximal observed concentration

  37. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    Cmax ss: maximum observed concentration at steady-state

  38. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    Cmin ss: minimum observed concentration at steady-state

  39. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    Tmax ss: time of observed Cmax at steady-state

  40. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    Tmax: Time of Cmax

  41. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    T½ el: Terminal elimination half-life

  42. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects (Kel) [ Time Frame: Up to 2 Weeks ]
    Kel: Terminal elimination rate constant

  43. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects (Racc) [ Time Frame: Up to 2 Weeks ]
    Racc: drug accumulation ratio

  44. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects (PTF%) [ Time Frame: Up to 2 Weeks ]
    PTF%: peak trough fluctuation

  45. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    Cl/F: Apparent body clearance, calculated as Dose / AUC0-inf

  46. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    Vd/F: apparent volume of distribution, calculated as Dose / Kel * AUC0-inf

  47. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    Clss/F: apparent body clearance at steady-state, calculated as dose / AUC0-inf

  48. To evaluate the pharmacokinetics (PK) of LQ036 after single and multiple doses of LQ036 administered via inhalation and IV routes in healthy subjects [ Time Frame: Up to 2 Weeks ]
    Vdss/F: apparent volume of distribution at steady-state, calculated as dose / (Kel * AUC0-inf)


Secondary Outcome Measures :
  1. To compare the PK of LQ036 after administration via inhalation and IV routes [ Time Frame: Up to 2 weeks ]
    Serum levels of LQ036 will be quantified for PK analysis by a validated enzyme linked immunosorbent assay (ELISA) method.

  2. To compare the safety and tolerability of LQ036 after administration via inhalation and IV routes (AUC0-24 versus AUC0-τ) [ Time Frame: Up to 2 weeks ]
    Comparisons between Day 1 and Day 10 PK parameters: AUC0-24 versus AUC0-τ will be done by Analysis of variance (ANOVA)

  3. To compare the safety and tolerability of LQ036 after administration via inhalation and IV routes (Cmax versus Cmax ss) [ Time Frame: Up to 2 weeks ]
    Comparisons between Day 1 and Day 10 PK parameters: Cmax versus Cmax ss will be done by Analysis of variance (ANOVA)

  4. To compare the safety and tolerability of LQ036 after administration via inhalation and IV routes (Tmax versus Tmax ss) [ Time Frame: Up to 2 weeks ]
    Comparisons between Day 1 and Day 10 PK parameters: Tmax versus Tmax ss will be done by Analysis of variance (ANOVA)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy as defined by:

    1. the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
    2. the absence of a clinically significant history of neurological, endocrine, cardiovascular, respiratory (except resolved childhood asthma), hematological, immunological, psychiatric (except including depression that has not required treatment for at least 6 months), gastrointestinal, renal, hepatic, and metabolic disease.
  • Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration:

    1. Simultaneous use of intrauterine device placed at least 4 weeks prior to study drug administration, and condom for the male partner;
    2. Simultaneous use of hormonal contraceptives started at least 4 weeks prior to study drug administration and condom for the male partner.
    3. Sterile male partner (vasectomized since at least 6 months).
  • Male subjects who are not vasectomized for at least 6 months, and who are sexually active with a female partner of childbearing potential (childbearing potential females are defined as women that are neither post-menopausal nor surgically sterile) must be willing to use one of the following acceptable contraceptive methods from the first study drug administration until at least 90 days after the last study drug administration:

    1. Simultaneous use of a male condom and, for the female partner, hormonal contraceptives used since at least 4 weeks, or intra-uterine contraceptive device placed since at least 4 weeks;
    2. Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
  • Subjects with normal lung function defined as greater than or equal to 80% predicted forced expiratory volume in one second (FEV1).
  • Capable of consent

Exclusion Criteria:

  • Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C found during medical screening.
  • Any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of check-in, or planned inpatient surgery or hospitalization during the study period.
  • Any history of malignancy or neoplastic disease (not including excised, non-recurrent, non-melanoma skin cancers).
  • Positive urine drug screen, urine cotinine test, or alcohol breath test at screening.
  • History of allergic reactions to LQ036, to any biologic therapy, or other related drugs, or to any excipient in the formulation.
  • Positive pregnancy test at screening.
  • Clinically significant ECG abnormalities or vital sign abnormalities (systolic blood pressure less than 90 or greater than 140 mmHg, diastolic blood pressure less than 50 or greater than 90 mmHg, or heart rate less than 50 or greater than 100 bpm) at screening.
  • History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit. Regular use of alcohol is defined as greater than 10 units of alcohol per week, where 1 unit is defined as 100 mL of wine at 13.5% a/v, 375 mL of beer at 3.5% a/v, or 30 mL of spirit at 40% a/v.
  • History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as tetrahydrocannabinol) within 1 month prior to the screening visit or hard drugs (amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, and phencyclidine) within 1 year prior to screening.
  • Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
  • Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):

    1. Prescription medications (except for hormonal contraceptives) within 14 days prior to the first dosing;
    2. Over-the-counter products and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to the first dosing, with the exception of the occasional use of paracetamol/acetaminophen (up to 2 g daily), ibuprofen (up to 800 mg daily), and oral contraceptives;
    3. Depot injection or implant (except for hormonal contraceptives) of any drug within 3 months prior to the first dosing;
    4. Long-acting ß2 agonists for 4 weeks prior to screening;
    5. Anti-immunoglobulin E,anti-Interleukin-5, or anti-Interleukin-4 Receptor therapy for 6 months prior to screening;
    6. Inhaled corticosteroids (greater than 500 μg/day of beclometasone dipropionate or equivalent) within 16 weeks prior to screening, and none for 4 weeks prior to screening;
    7. Oral or injectable steroids for the treatment of asthma or respiratory tract infection within 5 years prior to screening;
    8. Intranasal steroids within 4 weeks prior to screening;
    9. Topical steroids within 4 weeks prior to screening;
    10. Leukotriene antagonists within 2 weeks prior to screening;
    11. Anticholinergics or cromoglycate within 1 week prior to screening.
  • Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
  • Breast-feeding subject.
  • History of latent or active tuberculosis, or exposure to endemic areas within 8 weeks prior to QuantiFERON®-TB testing performed at screening.
  • Positive QuantiFERON®-TB test indicating possible tuberculosis infection.
  • Immunization with a live attenuated vaccine within 1 month prior to dosing or planned vaccination during the course of the study.
  • Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening.
  • History of clinically significant opportunistic infection (e.g., invasive candidiasis or one pneumocystis pneumonia).
  • History of parasitic diseases (e.g., toxoplasmosis, cysticercosis, toxocariasis).
  • History of frequent, recurrent herpes simplex.
  • Presence of fever (body temperature greater than 37.6 °C) e.g., a fever associated with a symptomatic viral or bacterial infection, within 2 weeks prior to the first dosing.
  • Life threatening asthmatic episode at any time in the past.
  • C-reactive protein level above 5 mg/L.
  • Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04993443


Contacts
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Contact: Philip Ryan, MBBS +61 438 009 787 p.ryan@nucleusnetwork.com.au

Locations
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Australia, Victoria
Nucleus Network Melbourne Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Philip Ryan, MBBS(Hons), BMedSc, PhD    +61 438 009 787    p.ryan@nucleusnetwork.com.au   
Sponsors and Collaborators
Syneos Health
Shanghai Novamab Biopharmaceuticals Co. Ltd.
Investigators
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Study Chair: Huaiyu Gu Shanghai Novamab Biopharm Co., Ltd.
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Responsible Party: Syneos Health
ClinicalTrials.gov Identifier: NCT04993443    
Other Study ID Numbers: LQ036A001
First Posted: August 6, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No