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Trial record 1 of 1 for:    LABP-104
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Safety Tolerability and Pharmacokinetics of Oral LABP-104 in Healthy Adult Male and Female Volunteers

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ClinicalTrials.gov Identifier: NCT05019950
Recruitment Status : Completed
First Posted : August 25, 2021
Last Update Posted : May 2, 2022
Sponsor:
Information provided by (Responsible Party):
Landos Biopharma Inc.

Brief Summary:
This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The primary objective of this study is to assess the safety and tolerability of single and 7-day repeat oral doses LABP-104 in healthy adult volunteers.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: LABP-104 250mg Drug: Placebo Phase 1

Detailed Description:

The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) and a multiple ascending dose (MAD) part (Part B). A total of 56 participants will be randomized in this study (35 in the SAD part, 21 in the MAD part).

SAD Part: Participants will be randomized to receive a single oral dose of LABP-104 (250 mg, 500 mg, 750 mg, 1000 mg or 1500 mg) or placebo after a 6-hour fast.

MAD Part: Participants will be randomized to receive LABP-104 (250 mg, 750 mg, or 1500 mg) or placebo once daily for 7 days after a 6-hour fast.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Single-Center Study to Evaluate Safety Tolerability and Pharmacokinetics of Oral LABP-104 in Healthy Adult Male and Female Volunteers
Actual Study Start Date : October 28, 2021
Actual Primary Completion Date : April 28, 2022
Actual Study Completion Date : April 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LABP-104 250mg

Dose escalation in the SAD part of the study (Part A) will be conducted in 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and randomized to receive either LABP-104 or placebo (ratio 5:2). LABP-104 will be administered to Cohort 1 participants at the starting dose of 250 mg and increased in each new cohort (500 mg, 750 mg, 1000 mg, 1500 mg).

It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either LABP-104 or placebo (ratio 5:2), once daily for seven days. LABP-104 dose levels to be evaluated in Part B will be 250 mg, 500 mg, and 1500 mg.

Drug: LABP-104 250mg

Dose escalation in the SAD part of the study (Part A) will be conducted in 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and randomized to receive either LABP-104 or placebo (ratio 5:2). LABP-104 will be administered to Cohort 1 participants at the starting dose of 250 mg and increased in each new cohort (500 mg, 750 mg, 1000 mg, 1500 mg).

It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either LABP-104 or placebo (ratio 5:2), once daily for seven days. LABP-104 dose levels to be evaluated in Part B will be 250 mg, 500 mg, and 1500 mg.


Placebo Comparator: Placebo

Dose escalation in the SAD part of the study (Part A) will be conducted in 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and randomized to receive either LABP-104 or placebo (ratio 5:2). LABP-104 will be administered to Cohort 1 participants at the starting dose of 250 mg and increased in each new cohort (500 mg, 750 mg, 1000 mg, 1500 mg).

It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either LABP-104 or placebo (ratio 5:2), once daily for seven days. LABP-104 dose levels to be evaluated in Part B will be 250 mg, 500 mg, and 1500 mg.

Drug: Placebo

Dose escalation in the SAD part of the study (Part A) will be conducted in 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and randomized to receive either LABP-104 or placebo (ratio 5:2). LABP-104 will be administered to Cohort 1 participants at the starting dose of 250 mg and increased in each new cohort (500 mg, 750 mg, 1000 mg, 1500 mg).

It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either LABP-104 or placebo (ratio 5:2), once daily for seven days. LABP-104 dose levels to be evaluated in Part B will be 250 mg, 500 mg, and 1500 mg.





Primary Outcome Measures :
  1. Incidence, severity and relationship of AEs; [ Time Frame: Part A: 37 days; Part B: 44 days ]
  2. Change from baseline in vital signs [ Time Frame: Part A: 37 days; Part B: 44 days ]
  3. Change from baseline in 12-lead ECG parameters; [ Time Frame: Part A: 37 days; Part B: 44 days ]
  4. Change from baseline in physical examination findings [ Time Frame: Part A: 37 days; Part B: 44 days ]
  5. Change from baseline in body weight (Part B only) [ Time Frame: Part A: 37 days; Part B: 44 days ]
  6. Change from baseline in clinical laboratory parameters (serum chemistry, hematology, coagulation, and urinalysis). [ Time Frame: Part A: 37 days; Part B: 44 days ]

Secondary Outcome Measures :
  1. Maximum Plasma Concentration [Cmax] [ Time Frame: Part A: 37 days; Part B: 44 days ]
  2. Time of the maximum drug concentration (tmax) [ Time Frame: Part A: 37 days; Part B: 44 days ]
  3. Area under the drug concentration-time curve (AUC0-last) [ Time Frame: Part A: 37 days; Part B: 44 days ]
  4. Apparent elimination rate constant (λz) [ Time Frame: Part A: 37 days; Part B: 44 days ]
  5. Area under the drug concentration-time curve from time zero to infinity (AUC0-inf) calculated as AUC0-t + Ct/λz, where λz is the apparent terminal elimination rate constant; [ Time Frame: Part A: 37 days; Part B: 44 days ]
  6. Area under the drug concentration-time curve from time zero to 24 hours following dose administration (AUC0-24); [ Time Frame: Part A: 37 days; Part B: 44 days ]
  7. Apparent total clearance of the drug from plasma following oral administration (CL/F), calculated as dose/AUC0-inf; [ Time Frame: Part A: 37 days; Part B: 44 days ]
  8. Apparent terminal elimination half-life (t1/2), calculated as ln(2)/λz; [ Time Frame: Part A: 37 days; Part B: 44 days ]
  9. Apparent volume of distribution Vd/F; calculated as (CL)/ λz. [ Time Frame: Part A: 37 days; Part B: 44 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects;
  2. Adult males and females, 18 to 64 years of age (inclusive) at screening;
  3. Body mass index (BMI) ≥ 18.0 and ≤ 31.0 kg/m2 , with a body weight ≥ 60.0 and ≤ 85.0 kg at screening;
  4. Be nonsmokers (including tobacco, e-cigarettes and marijuana) for at least 1 month prior to first study drug administration;
  5. Medically healthy without clinically significant abnormalities at screening and pre-dose on Day 1, including: a. Physical examination without any clinically relevant findings; b. Systolic blood pressure in the range of 90 to 160 mmHg and diastolic blood pressure in the range of 50 to 95 mmHg after 5 minutes in supine position; c. Heart rate (HR) in the range of 45 to 100 bpm after 5 minutes rest in supine position; d. Body temperature, between 35.0°C and 37.5°C; e. No clinically significant findings in serum chemistry, hematology, coagulation and urinalysis tests as judged by the investigator;
  6. Conventional 12-lead ECG recording in triplicate (the mean of triplicate measurements will be used to determine eligibility at screening and Day-1) consistent with normal cardiac conduction and function, including: a. Normal sinus rhythm with HR between 45 and 100 bpm, inclusive; b. QTcF between 350 to 450 msec for male participants and 350 to 470 msec for female participants, inclusive; c. QRS duration of ≤ 130 msec; d. PR interval of 120-240 msec, inclusive; e. Electrocardiogram morphology consistent with healthy cardiac ventricular conduction and normal rhythm, and with measurement of the QT interval; f. No family history of short or long QT syndrome; g. No history of risk factors for torsade de pointes or the diagnosis;
  7. Female participants must: a. Be of nonchildbearing potential ie, surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause), or b. If of childbearing potential, must have a negative pregnancy test at screening (blood test) and before the first study drug administration (Day -1 urine test). Participants must agree not to attempt to become pregnant, must not donate ova, and must use a highly effective contraceptive method (APPENDIX 4. Highly effective forms of birth control) in addition to their male partner using a condom if engaging in sexual intercourse from signing the consent form until at least 90 days after the last dose of study drug.
  8. Male participants, if not surgically sterilized, must be willing not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must be willing to use a condom in addition to having the female partner use a highly effective contraceptive method (APPENDIX 4. Highly effective forms of birth control) from signing the consent form until at least 90 days after the last dose of study drug.
  9. Have suitable venous access for blood sampling.
  10. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Exclusion Criteria:

  1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant;
  2. Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications;
  3. COVID-19: Testing positive for COVID-19, a current symptomatic infection within 20 days, or an asymptomatic infection within 6 weeks.
  4. Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma);
  5. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia;
  6. Use of or plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 4 months prior to the first study drug administration;
  7. Liver function test results (ie, AST, ALT, and gamma glutamyl transferase [GGT]) and total bilirubin must not be elevated more than 1.2-fold above the ULN;
  8. Positive test results for active human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies;
  9. History of active, latent or inadequately treated tuberculosis (TB) infection;
  10. Presence or having sequelae of gastrointestinal, liver, kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs;
  11. Impaired renal function as defined by estimated glomerular filtration rate (eGFR) < 90 mL/min;
  12. History of substance abuse or alcohol abuse within 12 months prior to first study drug administration;
  13. Positive drug or alcohol test results;
  14. Use of any prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements with the exception of hormonal contraceptives) within 10days or 5 half-lives of the medication (whichever is longer) prior to the first study drug administration, except occasional use of paracetamol;
  15. Demonstrated clinically significant (required intervention, e.g., emergency room visit, epinephrine administration) allergic reactions (e.g., food, drug, or atopic reactions, asthmatic episodes) which, in the opinion of the investigator, would interfere with the volunteer's ability to participate in the trial;
  16. Known hypersensitivity to any of the study drug ingredients;
  17. Use of any live vaccinations within 30 days prior to the first study drug administration;
  18. For women of childbearing potential, a positive serum pregnancy test at screening or a positive urine pregnancy test with confirmatory serum pregnancy test on Day -1;
  19. Donation of blood or plasma within 30 days prior to first study drug administration, or loss of whole blood of more than 500 mL within 30 days prior to randomization, or receipt of a blood transfusion within 1 year of first study drug administration;
  20. Participation in another investigational clinical trial within 60 days prior to the first study drug administration;
  21. Any other condition or prior therapy that in the opinion of the PI would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
  22. Is an employee of an investigator or sponsor or an immediate relative of an investigator.

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): NCT05019950


Locations
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Australia, Queensland
Nucleus Network
Herston, Queensland, Australia, 4006
Sponsors and Collaborators
Landos Biopharma Inc.
Investigators
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Study Director: Simon Lichtiger, MD Landos Biopharma
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Responsible Party: Landos Biopharma Inc.
ClinicalTrials.gov Identifier: NCT05019950    
Other Study ID Numbers: LABP-104-1a
First Posted: August 25, 2021    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases