Healthy Subjects (HS)
Conditions
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.
Interventions
DRUG626
Single subcutaneous injection
DRUGPlacebo
Single subcutaneous injection
Sponsors
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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/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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed