drugset
drugset / Trial / NCT06545162

Safety, Tolerability, and Pharmacokinetics of a Single or Multiple Ascending Doses of CPX101

NCT06545162 ↗

Phase 1 Completed 72 enrolled Guangzhou Chia Tai Innovative Pharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

This randomized, double-blind, placebo-controlled Phase I clinical study was designed to evaluate the tolerability and safety, PK profile, immunogenicity of CPX101 in a single dose in healthy participants and multiple doses in overweight and obese patients, and to initially explore the efficacy of multiple doses in weight loss. The study was divided into two parts: single administration and dose escalation (SAD) and multiple administration and dose escalation (MAD).

Timeline

Start
2024-12-04
Primary completion
2025-12-30
Completion
2025-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject CPX101 Unknown 80 mg Subcutaneous
Subject CPX101 Unknown 120 mg Subcutaneous
Subject CPX101 Unknown 160 mg Subcutaneous
Subject CPX101 Unknown 320 mg Subcutaneous

Indications

No indication recorded.