ClinicalTrials.gov record NCT07462780
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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This first-in-human, randomized, double-blind, placebo-controlled study investigates CMS-D017 capsules in healthy Chinese adults (aged 18–55). It has two parts: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase, each using sequential dose-escalation cohorts. The study will assess safety, tolerability, and how the drug is absorbed and processed in the body.
What it is studying. The study is measuring the safety and tolerability of CMS-D017 and characterizing its pharmacokinetics (how the body absorbs, distributes, and clears the drug) and pharmacodynamics (drug effects on the body), after single and repeated oral doses in healthy participants.
What the researchers hope to learn. To evaluate safety and tolerability, and to measure pharmacokinetic parameters (e.g., Cmax, Tmax, AUC, t1/2, clearance, volume of distribution) and pharmacodynamic effects including inhibition of the complement alternative pathway.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- CMS-D017 Capsule
- CMS-D017 Placebo Capsule
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
- Allergy History
- History of severe allergies, including food allergies, or allergy to the study drug or its components.
- Medical History/Conditions
- 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.
- 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:
- Torsades de pointes or risk factors (e.g., hypokalemia, hypomagnesemia, use of drugs causing delayed cardiac repolarization) History of cardiac arrest, syncope, heart failure; myocardial infarction, angina; valvular heart disease; cardiomyopathy or family history; clinically significant arrhythmias (e.g., sick sinus syndrome, atrioventricular conduction block, Adams-Stokes syndrome, Brugada syndrome or family history, long QT syndrome, atrial flutter, atrial fibrillation, supraventricular tachycardia, ventricular tachycardia).
- Prior/Concomitant Treatments
- Participation in any other clinical study involving drugs or medical devices within 3 months prior to screening, or planned participation in such studies during this study, or within 5 half-lives of that drug (whichever is longer).
- Vaccination within 4 weeks prior to screening or planned vaccination during the study or within 1 month after last dose (participants vaccinated against meningococcal and pneumococcal infections may be included if vaccination was completed at least 2 weeks before dosing).
- Use of known CYP2C8 or CYP3A inducers or inhibitors, or P-gp inhibitors within 4 weeks prior to dosing (see Appendix 2).
- Use of any prescription or over-the-counter drugs (including herbal medicines, vitamins, minerals, and dietary supplements) within 2 weeks or at least 5 half-lives prior to dosing, whichever is longer.
- Substance Use, Alcohol, Tobacco, or Nicotine, Dietary/Exercise Restrictions
- History of drug abuse within 6 months prior to screening, or positive result for any drug abuse test.
- Alcohol consumption exceeding 14 units per week within 3 months prior to screening (1 unit = 360 mL beer, 150 mL wine, or 45 mL spirits), or positive breath alcohol test, or inability to abstain from alcohol during the study.
- Average smoking of more than 5 cigarettes per day within 3 months prior to screening, or inability to stop using any tobacco products during the study.
- Inability to abstain from grapefruit or grapefruit-related citrus fruits or juices (e.g., pomelo) within 7 days prior to dosing and during the study.
- Consumption of caffeine-containing products (e.g., coffee, tea, cola, other caffeinated beverages, or chocolate) within 3 days prior to dosing, or refusal to avoid such products throughout the study.
- Engagement in strenuous exercise or physical activity within 3 days prior to dosing, or refusal to avoid such activities throughout the study.
- Examinations and Assessments
- Corrected QT interval (using Fridericia's formula, QTcF = QT/(RR\^0.33)) > 450 msec in males or females.
- Abnormal findings in physical examination, vital signs, safety laboratory tests, 12-lead ECG, or other auxiliary tests (chest X-ray, abdominal ultrasound) deemed clinically significant by the investigator.
- Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb), syphilis antibody (TPAb), or human immunodeficiency virus antibody (HIV Ab).
- Other
- Pregnant or lactating females.
- Special dietary requirements or inability to comply with standardized diet.
- Difficulty with venous blood sampling (e.g., history of needle or blood phobia), or poor venous condition as deemed unsuitable for enrollment by the investigator.
- Donation or loss of ≥ 400 mL blood within 3 months prior to screening, or receipt of blood transfusion or blood products; or planned blood or blood component donation during the study.
- Other conditions deemed unsuitable for participation in this study by the investigator.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants are randomized (double‑blind) into sequential single‑ascending‑dose or multiple‑ascending‑dose cohorts to receive oral CMS‑D017 capsules or matching placebo. Study procedures include safety monitoring (adverse‑event checks), repeated blood sampling for pharmacokinetics and pharmacodynamics, ECGs and other safety tests, and physical exams. Participants must follow restrictions around alcohol, smoking, grapefruit and certain foods/drinks, avoid strenuous exercise before dosing, and agree to contraception and blood‑donation restrictions. Blood draws and frequent clinic visits for dosing and monitoring are the main study burdens.
How the study is structured. Randomized, double-blind, placebo-controlled sequential dose-escalation. Part 1 (single ascending dose) includes six cohorts (8 participants per cohort; 6 receive CMS-D017, 2 receive placebo). Part 2 (multiple ascending dose) includes four cohorts (10 participants per cohort; 8 receive CMS-D017, 2 receive placebo). Participants receive either CMS-D017 capsules or matching placebo under blinded conditions while safety and PK/PD are monitored.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Paroxysmal Nocturnal Hemoglobinuria, PNH; Complement-mediated Kidney Disease. Does it apply to my diagnosis?
- Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on paroxysmal nocturnal hemoglobinuria
Important dates
- Study start
- Mar 5, 2026
- Primary completion
- November 2026 (estimated)
- Study completion
- December 2026 (estimated)
- Target enrollment
- 88 participants (estimated)
- Last updated on registry
- Apr 8, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Shenzhen Kangzhe Biotechnology Co., Ltd.
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Yulan Chen 📞 +86 10 6400 9673 ✉ chenyulan@cms.net.cn
- Le Peng 📞 +86 0755-82416868-792 ✉ pengle@cms.net.cn
Participating sites (1)
- Peking University Third HospitalRecruiting
Beijing · China
- Haiyan Li, Professor · +86 10 8226 6226 · haiyanli1027@hotmail.com
Terms used on this page · explanations by MedicalUpdates.ai
- first-in-human
- The first study in which a treatment is given to people. Safety is the main question and the number of participants is usually small.
- ascending dose
- Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
- pharmacokinetic
- How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
- pharmacodynamic
- What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- double-blind
- Two types of people involved in the study do not know which intervention a participant is receiving. The ClinicalTrials.gov record specifies who is masked, for example participants, care providers, investigators or outcome assessors.
- placebo-controlled
- A study design in which one group receives a placebo so that the study treatment's effects can be compared with no active treatment.
- cohort
- A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
- placebo
- A treatment that looks like the study treatment but contains no active ingredient. Some participants receive it instead of the study treatment, usually without knowing which they got.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- at screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- study drug
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- 5 half-lives
- The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
- QTcF
- A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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