NCT07462780

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Shenzhen Kangzhe Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Paroxysmal Nocturnal Hemoglobinuria, PNH
• Complement-mediated Kidney Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-05
• Primary completion: 2026-11-01
• Completion: 2026-12-01
• First posted: 2026-03-10
• Last updated: 2026-04-08

Locations

1 site across 1 country: China