NCT07483437

A Study of HS-20136-2 in Healthy Participants

A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Subcutaneous Administration of HS-20136-2 Injection in Healthy Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind,placebo-controlled phase I clinical study.The main purpose is to assess the safety and tolerability of single subcutaneous administration of HS-20136-2 injection in healthy participants.

Detailed description

This is a phase I, double-blind, randomised, placebo-controlled trial to assess the safety and tolerability of HS-20136-2 in healthy participants. We enrolled adults (aged 18-65 years, both inclusive) with body-mass index \[BMI\] ≥25 kg/m2 and ≤35 kg/m2 in Australia. Eligible participants were randomly assigned to receive a single dose subcutaneous injection of HS-20136-2 or placebo. The primary endpoint is： 1. Incidence, severity, and relationship to the investigational products of adverse events (AEs), serious adverse events (SAEs), and AEs leading to withdrawal from the study; 2. Changes in laboratory tests (hematology, urinalysis, blood biochemistry, coagulation function, etc.), vital signs, ECG results, etc., before and after administration.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HS-20136-2 injection	Administrated SC
DRUG	HS-20136-2 injection Placebo	Administrated SC

Timeline

• Start date: 2026-05-15
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

1 site across 1 country: Australia