NCT06545162

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

A Randomized, Double-blind, Placebo-controlled, Dose Escalation, Phase I Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of CPX101 in Healthy Volunteers and Overweight or Obese Patients With Multiple Doses

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Guangzhou Chia Tai Innovative Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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).

Detailed description

SAD: Three dose levels (80mg, 120mg, 160mg and200mg) were preset for this phase, and a total of 32 healthy participants were planned to be included. According to the dose increment principle, starting from the dose of 80mg, increasing successively to the high dose, and proceeding in sequence. MAD: The study was planned to include 48 adult overweight or obese participants, with a preset group of four cohorts, each with 12 participants. MAD1 to MAD 3cohorts were dosed with titration starting at 40mg and given once 1 week (QW) in each cohort. Up to the target dose of 80mgQ2W, 120mg Q2W and 160mg Q2W whereas MAD4 cohort were dosed with titration starting at 80mg and gived once 2week (Q2W) and up to target dose of 240 mg and exploratory of 320mg

Conditions

• Overweight and Obesity

Interventions

Type	Name	Description
BIOLOGICAL	CPX101 or placebo 80mg single dose	Subcutaneous injection of CPX101 or placebo
BIOLOGICAL	CPX101 or placebo 120mg single dose	Subcutaneous injection of CPX101 or placebo
BIOLOGICAL	CPX101 or placebo 160mg single dose	Subcutaneous injection of CPX101 or placebo
BIOLOGICAL	CPX101 or placebo 80mg Q2W	Subcutaneous injection of CPX101 or placebo
BIOLOGICAL	CPX101 or placebo 120mg Q2W	Subcutaneous injection of CPX101 or placebo
BIOLOGICAL	CPX101 or placebo 160mg Q2W	Subcutaneous injection of CPX101 or placebo
BIOLOGICAL	CPX101 or placebo 320mg Q2W	Subcutaneous injection of CPX101 or placebo

Timeline

• Start date: 2024-12-04
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2024-08-09
• Last updated: 2026-04-15

Locations

3 sites across 1 country: China