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Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SSS67 in Healthy Adult Participants Via Single Intravenous Infusion
Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
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
SSS67 Injection
In this Phase 1 single ascending dose trial, SSS67 Injection will be administered via intravenous infusion.
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