Evaluation of 626 in Healthy Adult Subjects
- Registration Number
- NCT06674525
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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/m2.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 626 Group S2 for subcutaneous injection 626 dose level 2 of 626 626 Group S1 for subcutaneous injection 626 dose level 1 of 626 626 Group S1 for subcutaneous injection Placebo dose level 1 of 626 626 Group S2 for subcutaneous injection Placebo dose level 2 of 626 626 Group S3 for subcutaneous injection 626 dose level 3 of 626 626 Group S3 for subcutaneous injection Placebo dose level 3 of 626 626 Group S4 for subcutaneous injection 626 dose level 4 of 626 626 Group S4 for subcutaneous injection Placebo dose level 4 of 626 626 Group S5 for subcutaneous injection 626 dose level 5 of 626 626 Group S5 for subcutaneous injection Placebo dose level 5 of 626 626 Group S6 for subcutaneous injection 626 dose level 6 of 626 626 Group S6 for subcutaneous injection Placebo dose level 6 of 626
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events 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 Outcome Measures
Name Time Method Cmax 90 days Peak concentration (Cmax) will be calculated.
Tmax 90 days Time to peak concentration (Tmax) will be calculated.
AUC0-last 90 days Area under the concentration-time curve from time 0 to the time point of last measurable concentration post-dose (AUC0-last) will be calculated.
Incidence of Anti-Drug Antibody 90 days Anti-drug antibody (ADA) positive rate and titer will be calculated. Incidence of neutralizing antibody (Nab) if ADA is positive.
Trial Locations
- Locations (1)
Shanghai General Hospital
🇨🇳Shanghai, China