NCT07057726

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSS39 Injection in Healthy Chinese Subjects

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of SSS39 Injection by Single Intravenous Infusion in Healthy Chinese Subjects

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety, tolerability, and pharmacokinetics of SSS39 injection in healthy Chinese subjects

Detailed description

This study was a single-administration, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK profile, immunogenicity, and effects on Treg cells and cytokines of SSS39 injection in healthy individuals.

Conditions

• Safety and Tolerability in Healthy Volunteers

Interventions

Type	Name	Description
DRUG	SSS39	Single oral administration of SSS39
DRUG	SSS39	Single oral administration of SSS39

Timeline

• Start date: 2024-10-09
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2025-07-10
• Last updated: 2025-07-10

Locations

1 site across 1 country: China