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RECRUITING
NCT07462780
PHASE1

A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Participants

Sponsor: Shenzhen Kangzhe Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a first-in-human (FIH) trial of CMS-D017 conducted in healthy Chinese adult participants, consisting of two parts: Part 1-a single ascending dose (SAD) study (referred to as Part 1 SAD), and Part 2-a multiple ascending dose (MAD) study (referred to as Part 2 MAD). The study aims to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of CMS-D017 capsules following single and multiple oral administrations in healthy Chinese adult participants. Both parts of the study are designed as randomized, double-blind, placebo-controlled, sequential cohort trials. Part 1 SAD plans to include 6 dose cohorts, with 8 participants per cohort (6 receiving CMS-D017 and 2 receiving placebo), for a total of 48 participants. Part 2 MAD plans to include 4 dose cohorts, with 10 participants per cohort (8 receiving CMS-D017 and 2 receiving placebo), for a total of 40 participants.

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, PK and PD Characteristics of CMS-D017 Following Single and Multiple Administrations in Healthy Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2026-03-05

Completion Date

2026-12

Last Updated

2026-04-08

Healthy Volunteers

Yes

Interventions

DRUG

CMS-D017 Capsule

healthy participant

DRUG

CMS-D017 Placebo Capsule

healthy participant

DRUG

CMS-D017 Capsule

healthy subject

DRUG

CMS-D017 Placebo Capsule

healthy subject

Locations (1)

Peking University Third Hospital

Beijing, China