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

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.

NCT Number	NCT07462780
Lead Sponsor	Shenzhen Kangzhe Biotechnology Co., Ltd.
Conditions	Paroxysmal Nocturnal Hemoglobinuria, PNH, Complement-mediated Kidney Disease
Enrollment	88 participants
Start Date	2026-03-05
Primary Completion	2026-11 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-04-08