A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Part… (NCT07462780) | Clinical Trial Compass
RecruitingPhase 1
A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Participants
China88 participantsStarted 2026-03-05
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. History of severe allergies, including food allergies, or allergy to the study drug or its components.
✕. 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.
What they're measuring
1
Safety and tolerability of CMS-D017 -Adverse events
✕. 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: