NCT06859853

A Study to Evaluate MWN109 Injection in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MWN109 Injection in Healthy Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Shanghai Minwei Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is a Phase1, randomized, double-blinded, and placebo-controlled study. In each cohort, enrolled participants will be randomized to receive either placebo or MWN109.

Detailed description

A total of 72 healthy volunteers are expected to be enrolled into this study. Study consists of 2 parts- Part A- Single Ascending dose (SAD) and part B- Multiple ascending dose (MAD). The entire study duration per participant is estimated to be a maximum of 8 weeks for the single ascending dose (SAD) part and 12 weeks for the multiple ascending dose (MAD) part. The end of study is defined as the date of the last visit of the last participant in the study.

Conditions

• Overweight or Obese

Interventions

Type	Name	Description
DRUG	Placebo	Sub cutaneous injection on the abdomen by a qualified member of study staff.
DRUG	Subcutaneous single and mutiple dose	Sub cutaneous injection on the abdomen by a qualified member of study staff.

Timeline

• Start date: 2025-03-17
• Primary completion: 2025-09-25
• Completion: 2025-11-25
• First posted: 2025-03-05
• Last updated: 2025-04-15

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study