Actively Recruiting
A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Participants
Led by Shenzhen Kangzhe Biotechnology Co., Ltd. · Updated on 2026-04-08
88
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agrees to participate and signs informed consent
- Able to communicate well with investigators and follow study requirements
- Aged between 18 and 55 years inclusive at consent
- Body Mass Index between 19.0 and 26.0 kg/m²
- Females weigh at least 45.0 kg; males weigh at least 50.0 kg
- Participants and their partners with reproductive capacity agree to use effective non-hormonal contraception from consent until 3 months after last dose
You will not qualify if you...
- History of severe allergies including to the study drug or its components
- Significant medical history or conditions requiring treatment that are unsuitable for study participation
- Conditions affecting drug absorption such as malabsorption syndrome or bowel surgery (except appendectomy)
- History of meningococcal infection or first-degree relatives with such history
- Active infection or acute illness within 2 weeks prior to screening
- Current tuberculosis infection or positive TB test
- Recent severe trauma or surgery within 8 weeks before screening or planned surgery during study
- History or presence of serious cardiac risk factors or arrhythmias
- Participation in other clinical trials within 3 months before screening or planned participation during study
- Vaccination within 4 weeks before screening or planned vaccination during study or within 1 month after last dose, except certain completed vaccinations
- Use of certain enzyme inducers or inhibitors within 4 weeks prior to dosing
- Use of any medications or supplements within 2 weeks or 5 half-lives prior to dosing
- History of drug abuse within 6 months or positive drug abuse test
- Alcohol intake exceeding 14 units weekly within 3 months prior or inability to abstain during study
- Smoking more than 5 cigarettes daily within 3 months prior or inability to stop during study
- Inability to avoid grapefruit or related products within 7 days before dosing and during study
- Consumption of caffeine-containing products within 3 days prior to dosing or refusal to avoid during study
- Engaging in strenuous exercise within 3 days prior to dosing or refusal to avoid during study
- Corrected QT interval over 450 msec
- Abnormal physical exam or laboratory findings considered clinically significant
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Pregnant or breastfeeding females
- Special dietary needs or inability to follow standardized diet
- Difficulty with venous blood sampling or poor vein condition
- Blood donation or loss of 400 mL or more within 3 months prior, or planned donation during study
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yulan Chen
CONTACT
L
Le Peng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here