Evaluating SSGJ-626 in Healthy Adults
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
This study is testing a new treatment called SSGJ-626 in healthy adults to see if it's safe and how it affects their bodies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06674525 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, double-blind, placebo-controlled phase I study designed to assess the safety, tolerability, pharmacokinetics, and immunogenicity of SSGJ-626 in healthy adult participants. The study will involve six dose groups, with participants receiving a single subcutaneous injection of either the treatment or a placebo. Blood samples will be collected throughout the study to monitor various health metrics and responses to the treatment. The trial aims to provide critical data on the effects of SSGJ-626 in a controlled environment.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18-45 years who meet specific weight and BMI criteria.
Not a fit: Patients with significant allergies, clinically significant diseases, or a history of substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of a new treatment option that is safe and effective for future applications.
How similar studies have performed: Other studies evaluating similar interventions have shown promise, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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/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.
Where this trial is running
Shanghai
- Shanghai General Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Qinghong Zhou
- Email: zhouqinghong@3sbio.com
- Phone: +86 18911301578
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.