NCT06674525

Evaluation of 626 in Healthy Adult Subjects

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects (HS)

Interventions

Type	Name	Description
DRUG	626	Single subcutaneous injection
DRUG	Placebo	Single subcutaneous injection

Timeline

• Start date: 2024-12-02
• Primary completion: 2025-06-01
• Completion: 2025-10-01
• First posted: 2024-11-05
• Last updated: 2024-12-10

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study