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

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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

NCT07462780•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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Voluntarily participates in this study and signs the informed consent form.
•2. 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.
•3. Aged 18-55 years (inclusive, as of the day of signing the informed consent form), male or female.
•4. 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.
•5. 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.

Exclusion Criteria

•Allergy History
•1. History of severe allergies, including food allergies, or allergy to the study drug or its components.
•Medical History/Conditions
•2. 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.
•3. 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).
•4. History of meningococcal infection or first-degree relatives with history of meningococcal infection.
•5. Active infection or acute disease state (e.g., fever, nausea, vomiting, or diarrhea) within 2 weeks prior to screening.
•6. Current history of tuberculosis infection; or positive tuberculosis (TB) test result. Note: If the TB test result is indeterminate, one repeat test is allowed.
•7. History of severe trauma or surgery within 8 weeks prior to screening, or planned surgery during the study period.
•8. History or current presence of the following cardiac risk factors:
+23 more criteria

Locations (1)

Peking University Third Hospital

Beijing, China

Key Dates

Start Date

March 1, 2026

Primary Completion Date

November 1, 2026

Completion Date

December 1, 2026

Last Updated

March 10, 2026

Enrollment

ESTIMATED participants

Conditions

Paroxysmal Nocturnal Hemoglobinuria, PNHComplement-mediated Kidney Disease

Interventions

CMS-D017 Capsule

DRUG

CMS-D017 Placebo Capsule

DRUG

CMS-D017 Capsule

DRUG

CMS-D017 Placebo Capsule

DRUG

Contacts

Yulan Chen

CONTACT

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

Le Peng

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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