A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShenzhen Kangzhe Biotechnology Co., Ltd.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- CMS-D017 Capsule
- CMS-D017 Placebo Capsule
- CMS-D017 Capsule
- CMS-D017 Placebo Capsule
Treatment groups
88 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov