drugset
drugset / Trial / NCT07487545

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

NCT07487545 ↗

Phase 1 Not yet recruiting 52 enrolled Shenyang Sunshine Pharmaceutical Co., LTD.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-03-31
Primary completion
2026-08-29
Completion
2027-04-02

Drugs

EvaluationDrugModalityDoseRoute
Subject SSS67 Unknown 1 mg/kg Intravenous
Subject SSS67 Unknown 5 mg/kg Intravenous
Subject SSS67 Unknown 15 mg/kg Intravenous
Subject SSS67 Unknown 30 mg/kg Intravenous
Subject SSS67 Unknown 45 mg/kg Intravenous
Subject SSS67 Unknown 60 mg/kg Intravenous

Indications

No indication recorded.