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

NCT06545162 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-04-15

No results posted yet for this study

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).

Conditions

  • Overweight and Obesity

Interventions

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

Sponsors & Collaborators

  • Guangzhou Chia Tai Innovative Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06545162 on ClinicalTrials.gov