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NOT YET RECRUITING
NCT07487545
PHASE1

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

Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2026-03-31

Completion Date

2027-04-02

Last Updated

2026-03-23

Healthy Volunteers

Yes

Conditions

Interventions

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.

Locations (2)

Novatrials

Charlestown, New South Wales, Australia

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China