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

NCT07462780 | Recruiting Phase 1 DMC

• 1 other identifier: D017-01-001
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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

Complement-mediated Kidney Disease; Paroxysmal Nocturnal Hemoglobinuria, PNH

Keywords

CMS-D017; Phase I trial in healthy participants; single and multiple ascending dose studies; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of CMS-D017 -Adverse events

  Monitoring of adverse events

  Up to 23 days

Secondary Outcomes (13)

• Tmax

  Up to 16 days

• Rac_Cmax

  Up to 16 days

• Cmax

  Up to 16 days

• AUC

  Up to 16 days

• λz

  Up to 16 days

Study Arms (4)

Single Dose Escalation of CMS-D017

EXPERIMENTAL

6 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo

Drug: CMS-D017 Capsule

Single Dose Escalation- placebo

PLACEBO COMPARATOR

6 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo

Drug: CMS-D017 Placebo Capsule

Multiple Dose Escalation of CMS-D017

EXPERIMENTAL

4 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo

Drug: CMS-D017 Capsule

Multiple Dose Escalation of placebo

EXPERIMENTAL

4 sequential dose escalation cohorts - participants are randomized either to investigational drug or matching placebo

Drug: CMS-D017 Placebo Capsule

Interventions

CMS-D017 Capsule DRUG

healthy participant

Single Dose Escalation of CMS-D017

CMS-D017 Placebo Capsule DRUG

healthy participant

Single Dose Escalation- placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily participates in this study and signs the informed consent form.
• Able to communicate well with the investigator and understands and complies with all requirements and restrictions of this study, and is able to complete the study in accordance with the protocol.
• Aged 18-55 years (inclusive, as of the day of signing the informed consent form), male or female.
• Body Mass Index (BMI) between 19.0 and 26.0 kg/m² (inclusive) at screening, with females weighing ≥ 45.0 kg and males weighing ≥ 50.0 kg.
• Participants (and their partners) with reproductive capacity must have no plans for pregnancy, egg donation, or sperm donation from the date of signing the informed consent form until 3 months after the last dose of the study drug, and must comply with contraceptive requirements (see Appendix 1), agreeing to use at least one highly effective non-hormonal contraceptive method.

You may not qualify if:

• Allergy History
• History of severe allergies, including food allergies, or allergy to the study drug or its components.
• Medical History/Conditions
• Significant history or clinical manifestations of cardiovascular, respiratory, digestive, urogenital, hematologic, endocrine and metabolic, rheumatic, immunologic, neuropsychiatric, or musculoskeletal diseases requiring medication and/or other treatments (including dietary restrictions and physical therapy), as deemed unsuitable for participation in this study by the investigator.
• Any condition that may affect drug absorption, including but not limited to: malabsorption syndrome, inflammatory bowel disease, celiac disease, gastrectomy, cholecystectomy, bowel resection (except appendectomy).
• History of meningococcal infection or first-degree relatives with history of meningococcal infection.
• Active infection or acute disease state (e.g., fever, nausea, vomiting, or diarrhea) within 2 weeks prior to screening.
• Current history of tuberculosis infection; or positive tuberculosis (TB) test result. Note: If the TB test result is indeterminate, one repeat test is allowed.
• History of severe trauma or surgery within 8 weeks prior to screening, or planned surgery during the study period.
• History or current presence of the following cardiac risk factors:
• Torsades de pointes or risk factors (e.g., hypokalemia, hypomagnesemia, use of drugs causing delayed cardiac repolarization) History of cardiac arrest, syncope, heart failure; myocardial infarction, angina; valvular heart disease; cardiomyopathy or family history; clinically significant arrhythmias (e.g., sick sinus syndrome, atrioventricular conduction block, Adams-Stokes syndrome, Brugada syndrome or family history, long QT syndrome, atrial flutter, atrial fibrillation, supraventricular tachycardia, ventricular tachycardia).
• Prior/Concomitant Treatments
• Participation in any other clinical study involving drugs or medical devices within 3 months prior to screening, or planned participation in such studies during this study, or within 5 half-lives of that drug (whichever is longer).
• Vaccination within 4 weeks prior to screening or planned vaccination during the study or within 1 month after last dose (participants vaccinated against meningococcal and pneumococcal infections may be included if vaccination was completed at least 2 weeks before dosing).
• Use of known CYP2C8 or CYP3A inducers or inhibitors, or P-gp inhibitors within 4 weeks prior to dosing (see Appendix 2).

Sponsors & Collaborators

• Shenzhen Kangzhe Biotechnology Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Hemoglobinuria, Paroxysmal

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases

Central Study Contacts

Yulan Chen

CONTACT

+86 10 6400 9673; chenyulan@cms.net.cn

Le Peng

CONTACT

+86 0755-82416868-792; pengle@cms.net.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 10, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)