NCT05195541

A Clinical Study to Evaluate the Safety, Pharmacokinetic Profile and Efficacy of CU-20401

A Clinical Study to Evaluate the Safety, Pharmacokinetic Profile and Efficacy of CU-20401 Administered Subcutaneously in the Submental Fat (SMF) Population

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Cutia Therapeutics（Wuxi）Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is a Phase Ib/II clinical study. Phase 1b was a single-center, nonrandomized, single-arm study to evaluate the safety, PK profile, preliminary efficacy, and immunogenicity of different groups (SC) of CU-20401 in the submental fat accumulation population. Phase 2 is a multicenter, randomized, placebo parallel-controlled study to evaluate the safety, efficacy, and immunogenicity of the preferred group (SC) of CU-20401 in a submental fat accumulation population.

Detailed description

Eligible subjects will first enter Arm A1, receive treatment for this group on D1, and undergo study visits and biological sample collection (PK samples and immunogenicity samples) at established timepoints. After the last subject in Arm A1 has completed at least 3 days of safety and tolerability observation,After no safety events (≥ Grade 2 study drug-related AEs) have occurred as assessed by the investigator, enrollment into the A2 Arm may be initiated. Enrollment in subsequent treatment groups and so on. If a subject in this dose group experiences an AE ≥ Grade 2 related to the investigational product, the investigator will assess the time to continue observation and start the next treatment group according to the subject ' s condition. Based on the data obtained in Phase 1b, the grouping for Phase 2 will be determined by the investigator and the sponsor in consultation. It may be Group X1, Group X2, and Group X3. Eligible subjects were randomized 1: 1: 1: 1 to receive treatment in Group X1, X2, X3, or placebo on D1 and to undergo study visits and biological sample collection (immunogenicity samples) at established timepoints.

Conditions

• Safety

Interventions

Type	Name	Description
DRUG	CU-20401	Subcutaneous injection in the subcutaneous fat area，0.2ml

Timeline

• Start date: 2022-02-27
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2022-01-19
• Last updated: 2024-12-10

Locations

1 site across 1 country: China