A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SSGJ-626 in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- 626
- Conditions
- Healthy Subjects (HS)
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of participants with Adverse Events
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-626 in healthy adult subjects after single subcutaneous injection.
Detailed Description
Six dose groups are planned for dose escalation in this study. Subjects in all dose groups will receive a single subcutaneous injection. Group S1 follows open-labeled, single-arm design, Groups S2 to S6 follow randomized, double-blinded, placebo-control design. Blood samples will be collected for PK, immunogenicity, biomarkers, laboratory tests, etc. according to the study schedule throughout the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to understand protocol requirements and sign a written ICF.
- •Male or female subjects aged 18-45 years when signing the ICF.
- •Male subjects with body weight ≥ 50 kg, and female subjects with body weight ≥ 45 kg. Subjects with BMI between 18 and 28 kg/m
- •Subjects whose test results are normal, or abnormal without clinical significance as determined by the investigator.
- •Female subjects with childbearing potential and male subjects (and their female partners) must agree to take highly effective contraceptive measures.
Exclusion Criteria
- •History of severe allergy, or with a history of allergy to the study treatment or related excipients.
- •With any clinically significant diseases prior to the screening visit.
- •Subjects with positive test results for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibody, anti-human immunodeficiency virus (HIV) antibody.
- •History of of significant alcohol abuse.
- •History of significant drug abuse.
- •Subjects who have positive result for urine nicotine test at screening.
- •Pregnant, or nursing females.
Arms & Interventions
626 Group S1 for subcutaneous injection
dose level 1 of 626
Intervention: 626
626 Group S1 for subcutaneous injection
dose level 1 of 626
Intervention: Placebo
626 Group S2 for subcutaneous injection
dose level 2 of 626
Intervention: 626
626 Group S2 for subcutaneous injection
dose level 2 of 626
Intervention: Placebo
626 Group S3 for subcutaneous injection
dose level 3 of 626
Intervention: 626
626 Group S3 for subcutaneous injection
dose level 3 of 626
Intervention: Placebo
626 Group S4 for subcutaneous injection
dose level 4 of 626
Intervention: 626
626 Group S4 for subcutaneous injection
dose level 4 of 626
Intervention: Placebo
626 Group S5 for subcutaneous injection
dose level 5 of 626
Intervention: 626
626 Group S5 for subcutaneous injection
dose level 5 of 626
Intervention: Placebo
626 Group S6 for subcutaneous injection
dose level 6 of 626
Intervention: 626
626 Group S6 for subcutaneous injection
dose level 6 of 626
Intervention: Placebo
Outcomes
Primary Outcomes
Number of participants with Adverse Events
Time Frame: 90 days
Incidence of adverse events will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.
Secondary Outcomes
- Cmax(90 days)
- Tmax(90 days)
- AUC0-last(90 days)
- Incidence of Anti-Drug Antibody(90 days)