NCT07065136

Evaluation of 627 in Healthy Adult Subjects

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of SSGJ-627 in Healthy Adult Subjects

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (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 and multiple ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-627 in healthy adult subjects after single subcutaneous injection.

Detailed description

Seven dose groups are planned for dose escalation in SAD of this study. Subjects in all dose groups will receive a single subcutaneous injection. Group S1 follows open-labeled, single-arm design, Groups S2 to S7 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
BIOLOGICAL	627	subcutaneous injection
OTHER	Placebo	Single subcutaneous injection

Timeline

• Start date: 2025-07-20
• Primary completion: 2026-09-18
• Completion: 2026-09-18
• First posted: 2025-07-15
• Last updated: 2025-07-15

Regulatory

• FDA-regulated drug study