Actively Recruiting
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
Led by Shenzhen Kangzhe Biotechnology Co., Ltd. · Updated on 2026-04-08
88
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a first-in-human clinical trial to study CMS-D017 capsules in healthy Chinese adults aged 18 to 55 years. This phase 1 trial aims to evaluate the safety, tolerability, pharmacokinetics (how the drug moves through the body), and pharmacodynamics (the drug's effects) following single and multiple oral doses. The study is randomized, double-blind, and placebo-controlled, including healthy participants without active disease or significant medical conditions. The trial has two parts: Part 1 is a single ascending dose (SAD) study with six dose groups, each having eight participants randomized to receive CMS-D017 or placebo. Part 2 is a multiple ascending dose (MAD) study with four dose groups, each including ten participants also randomized to drug or placebo. Participants will take the study capsules according to their assigned dosing schedule to assess how the drug behaves after one dose and after multiple doses. Participants will undergo safety monitoring for up to 23 days, including adverse event tracking. Pharmacokinetic and pharmacodynamic measurements will be collected for up to 16 days to assess drug absorption, distribution, metabolism, elimination, and biological effects. The study involves clinical exams, vital signs, ECG, laboratory tests, and questionnaires to evaluate tolerability and drug effects. The total time commitment varies depending on the dosing cohort and study part.
CONDITIONS
Brief 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 and comply with study requirements
- Aged 18 to 55 years, male or female
- 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 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 or allergy to study drug or components
- Significant medical history or conditions requiring treatment deemed unsuitable
- Conditions affecting drug absorption like malabsorption syndrome or bowel surgery
- History of meningococcal infection or family history
- Active infection or illness within 2 weeks before screening
- Current or past tuberculosis infection or positive TB test
- 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 drug or device studies within 3 months before screening
- Vaccination within 4 weeks before screening or planned vaccination during study
- Use of CYP2C8, CYP3A inducers/inhibitors, or P-gp inhibitors within 4 weeks before dosing
- Use of any prescription or OTC drugs within 2 weeks before dosing
- History of drug abuse within 6 months before screening
- Excessive alcohol use or inability to abstain during study
- Smoking more than 5 cigarettes daily or inability to stop tobacco use during study
- Inability to avoid grapefruit, caffeine, or strenuous exercise before and during study
- Corrected QT interval over 450 msec
- Abnormal clinical or lab findings deemed significant
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
- Pregnant or breastfeeding females
- Special dietary needs or inability to follow study diet
- Difficulty with blood sampling or poor veins
- Blood donation or transfusion within 3 months before screening or planned during study
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 days
Participants receive single or multiple doses of CMS-D017 or placebo as part of dose escalation cohorts.
Multiple visits during dosing and assessments up to 16 days
Duration - Up to 7 days after last dose (completing up to 23 days total)
Participants are monitored for safety and tolerability following dosing.
Follow-up visits until Day 23
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yulan Chen
L
Le Peng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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