NCT07058779

Safety, Tolerability, PK and PD of SSS55 in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of SSS55 Injection in Healthy Subjects in China

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study was a single-dose, randomized, double-blind, placebo-controlled study of SSS55 injection to evaluate the safety, tolerability, PK characteristics, immunogenicity and preliminary efficacy characteristics of single-dose SSS55 injection in healthy individuals.

Detailed description

This study was a single-dose, randomized, double-blind, placebo-controlled study of SSS55 injection to evaluate the safety, tolerability, PK characteristics, immunogenicity and preliminary efficacy characteristics of single-dose SSS55 injection in healthy individuals.In this trial, four dose groups were preset. The initial dose and dose level were relatively low. Two subjects were planned to be enrolled and only received SSS55 administration. In the subsequent dose group, sentries were set up in each group. In each group, the first two subjects were randomly administered with sentries at a ratio of 1:1 between the test drug SSS55 and the placebo. The sentries were involved in blinding. After the sentries completed the safety assessment 8 days after administration, the remaining subjects in the group were administered in a random ratio between the test drug group and the placebo group.

Conditions

• Safety Issues

Interventions

Type	Name	Description
DRUG	SSS55	SSS55 is an injection targeting complement C3b

Timeline

• Start date: 2025-08-04
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-07-10
• Last updated: 2026-03-02

Locations

1 site across 1 country: China