NCT07487545

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SSS67 in Healthy Adult Participants Via Single Intravenous Infusion

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SSS67 in Healthy Adult Participants Via Single Intravenous Infusion

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 65 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, preliminary PD and immunogenicity of SSS67 in healthy adult participants after single intravenous infusion. The primary objective is to assess the safety and tolerability of SSS67 following single ascending doses. The secondary objectives are to characterize the PK, PD, and anti-drug antibody (ADA) profiles of SSS67 after single administration. The exploratory objective is to evaluate changes in body weight, waist circumference, and other related metabolic parameters following a single dose of SSS67.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SSS67 Injection	In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion.
DRUG	Placebo	Participants will receive a single dose of matching placebo in accordance with their randomly assigned treatment group.

Timeline

• Start date: 2026-03-31
• Primary completion: 2026-08-29
• Completion: 2027-04-02
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

2 sites across 2 countries: Australia, China

Regulatory

• FDA-regulated drug study