Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection

• ClinicalTrials.gov Identifier: NCT05027373
• Recruitment Status: Recruiting
• First Posted: August 30, 2021
• Last Update Posted: August 30, 2021
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• Information provided by (Responsible Party): Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study Description

Brief Summary:

This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-1β Humanized Monoclonal Antibody injection in Healthy Subjects. Pharmacokinetics, Pharmacodynamics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerability and immunogenicity for healthy subjects will be evaluated.

Condition or disease	Intervention/treatment	Phase
Systemic Juvenile Idiopathic Arthritis; Periodic Fever Syndrome	Drug: SSGJ-613; Drug: Placebo	Phase 1

Detailed Description:

This study is a randomized, double-blind, placebo-controlled parallel trial of safety, tolerability and pharmacokinetic of Recombinant anti-IL-1β Humanized Monoclonal Antibody by single subcutaneous injection with five different doses in healthy subjects. There are 5 groups as follows: 0.03mg/kg (S1), 1.0mg/kg (S2), 3.0mg/kg (S3), 6.0mg/kg (S4) and 10.0mg/kg (S5); and 2 subjects were included in the S1 group (both received study drugs); 8 subjects were included in each of the S2 ~ S5 groups (of which 6 received study drugs and 2 received placebo). In each group, two subjects were sentinels (1 received the study drug and 1 placebo). Pharmacokinetics, Pharmacodynamics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerability and immunogenicity for healthy subjects will be evaluated.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Placebo-controlled Parallel Trial of Safety, Tolerability and Pharmacokinetic of Recombinant Anti-IL-1β Humanized Monoclonal Antibody by Single Subcutaneous Injection in Healthy Subjects
• Actual Study Start Date: August 13, 2021
• Estimated Primary Completion Date: April 30, 2022
• Estimated Study Completion Date: September 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: SSGJ-613	Drug: SSGJ-613; SSGJ-613 injection is 200mg/2mL solution in a single vial.The solution is a clear to slightly opalescent, colorless to a slightly yellow tint.
Placebo Comparator: Placebo	Drug: Placebo; Placebo injection is 2mL excipient solution in a single vial.The solution is clear and colorless.

Outcome Measures

Primary Outcome Measures :

1. Cmax [ Time Frame: up to 112 days ]
2. Tmax [ Time Frame: up to 112 days ]
3. AUC0-t [ Time Frame: up to 112 days ]
4. t1/2 [ Time Frame: up to 112 days ]
5. CL/F [ Time Frame: up to 112 days ]
6. Vd/F [ Time Frame: up to 112 days ]
7. Ke [ Time Frame: up to 112 days ]
8. AUC0-∞ [ Time Frame: up to 112 days ]
9. AE [ Time Frame: up to 112 days ]
10. SAE [ Time Frame: up to 112 days ]

Secondary Outcome Measures :

1. total IL-1β [ Time Frame: up to 112 days ]
2. free IL-1β [ Time Frame: up to 112 days ]
3. ADA [ Time Frame: up to 112 days ]
   Bridging method will be used to detect the incidence and titer for ADA through one three-step detection strategy, that is preliminary screening, confirmation and titer

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Chinese healthy participants, male or female, aged 18 to 45 (including both ends)
• The body mass index (BMI) is in the range of 19.0~28.0 kg•m-2 (including both ends), and the weight of men is generally not less than 50kg, while the women is generally not less than 45kg
• Male participants and their partners or female participants must agree to take one or more non-drug contraceptives (such as complete abstinence, contraceptive rings, partner ligation, etc.) , and there is no sperm donation or egg donation plan until 3 months after finished the study
• Participants should fully understand the purpose, nature, methods and possible adverse reactions of the trial, volunteer to participate in the trial and sign the informed consent
• Participants could communicate well with the researchers and compliance with the trial

Exclusion Criteria:

• Those who are allergic to the study drug and any of its excipients. Subjects who have a history of allergy to monoclonal antibodies
• Subjects who have or are currently suffering from any serious clinical diseases 3-6 months before screening, such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry and metabolic abnormalities or any other that can interfere with the study results
• Clinical laboratory examinations (blood routine, urine routine, blood biochemistry, coagulation function, etc.), auxiliary examinations (chest X-ray, abdominal ultrasound) found to be abnormal and have clinical significance
• Positive for Hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), anti- Hepatitis C virus antibodies (HCV), or anti-human immunodeficiency virus (HIV)
• Alcoholics or frequent drinkers within 3 months before the trial, drinking more than 14 units per week (1 unit alcohol ≈360 mL beer or 45 mL spirits or 150 mL wine), or those who have a positive alcohol breath test (screening period or baseline period) or couldn't prohibit alcohol during the trial
• Those who smoked more than 5 cigarettes per day during the 3 months before screening, or have a positive urine nicotine screening test (screening period or baseline period)
• Drug abusers or those who have used soft drugs (such as marijuana) within 3 months or took hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the trial, or have positive drug abuse screening (morphine, Ketamine, tetrahydrocannabinol acid, methamphetamine , dimethyldioxyamphetamine, cocaine)
• Has taken any prescription medicine, non-prescription medicine, Chinese patent medicine within 14 days before administration
• Has received any monoclonal antibody drugs within 3 months before administration
• Has a history of vaccination within 3 months before dosing, or intend to receive vaccines during the study
• Was previously enrolled in other clinical trials within 3 months before dosing
• Blood donors or subjects who lost a lot of blood (> 400 mL, except for women's physiological period) or those who received blood transfusion or used blood products within 3 months
• Can't tolerate venipuncture or has a history of halo needles and halo blood
• Has known or suspected pregnancy or lactation
• Abnormal vital signs (SBP <90 mmHg or ≥140 mmHg, DBP <55 mmHg or ≥90 mmHg; heart rate <50 bpm or> 100 bpm; body temperature <35.4℃ or > 37.3℃) or abnormal ECG (QTcF ≥450 ms) or physical examination are clinically significant (according to the judgment of clinical research doctors)

• Those who are infected and need to be treated for acute or chronic infections, as follows:

  • Suffering from herpes zoster within 12 months before screening;
  • Currently in any inhibitory treatment for chronic infections (eg, tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster virus, and atypical mycobacteria);
  • A history of tuberculosis or contact with patients with open tuberculosis in the past 6 months,or a T-spoT-positive results;
  • Infected with parasites within 3 months before administration;
  • Hospitalized for infectious diseases within 30 days before administration;
  • Received anti-infective drugs (including antibacterial, antiviral, antifungal, or antiparasitic drugs) by parenteral administration (iv or im) 30 days before administration
• Subjects who are unsuited to the study for any reason, judged by the investigators

Contacts and Locations

Contacts

Contact: Qian Chen, PhD; 02154030254; qchen@shxh-centerlab.com

Locations

China, Shanghai

Shanghai Xuhui District Central Hospital; Recruiting

Shanghai, Shanghai, China, 201203

Contact: Chuan Lu

Sponsors and Collaborators

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

More Information

• Responsible Party: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05027373
• Other Study ID Numbers: SSGJ-613-HH-I-01
• First Posted: August 30, 2021
• Last Update Posted: August 30, 2021
• Last Verified: August 2021

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

Additional relevant MeSH terms:

Arthritis, Juvenile; Familial Mediterranean Fever; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn