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

NCT07462780 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-04-08

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shenzhen Kangzhe Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2026-03-05
Primary Completion
2026-11-30
Completion
2026-12-31

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 NCT07462780 on ClinicalTrials.gov