CMS-D017 capsules: single and multiple dose testing in healthy adults
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
This trial will test CMS-D017 capsules in healthy Chinese adults to see if single and multiple oral doses are safe and how the drug behaves in the body.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Shenzhen Kangzhe Biotechnology Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07462780 on ClinicalTrials.gov |
What this trial studies
This first-in-human, randomized, double-blind, placebo-controlled Phase I trial tests single ascending dose (SAD) and multiple ascending dose (MAD) oral administration of CMS-D017 in healthy Chinese adults. Part 1 (SAD) includes six sequential dose cohorts of eight participants each (six receiving CMS-D017 and two receiving placebo) and Part 2 (MAD) includes four sequential cohorts of ten participants each (eight receiving CMS-D017 and two receiving placebo), for a total of 88 participants. The study will collect safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data after single and repeated dosing. Findings will guide dose selection and safety planning for later patient trials.
Who should consider this trial
Good fit: Ideal participants are healthy Chinese adults aged 18–55 with a BMI of 19.0–26.0 kg/m² who meet the protocol’s health and contraceptive requirements and can complete all study visits.
Not a fit: People with PNH or complement-mediated kidney disease should not expect therapeutic benefit from this healthy-volunteer first-in-human study.
Why it matters
Potential benefit: If successful, CMS-D017 could become an oral complement-targeting treatment option for conditions such as paroxysmal nocturnal hemoglobinuria and complement-mediated kidney disease.
How similar studies have performed: This is a first-in-human trial of CMS-D017, but other complement-targeting therapies (for example, eculizumab) have shown clinical benefit in PNH and some complement-mediated kidney diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Voluntarily participates in this study and signs the informed consent form.
2. 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.
3. Aged 18-55 years (inclusive, as of the day of signing the informed consent form), male or female.
4. 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.
5. 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
1. History of severe allergies, including food allergies, or allergy to the study drug or its components.
Medical History/Conditions
2. 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.
3. 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).
4. History of meningococcal infection or first-degree relatives with history of meningococcal infection.
5. Active infection or acute disease state (e.g., fever, nausea, vomiting, or diarrhea) within 2 weeks prior to screening.
6. Current history of tuberculosis infection; or positive tuberculosis (TB) test result. Note: If the TB test result is indeterminate, one repeat test is allowed.
7. History of severe trauma or surgery within 8 weeks prior to screening, or planned surgery during the study period.
8. 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
9. 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).
10. 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).
11. Use of known CYP2C8 or CYP3A inducers or inhibitors, or P-gp inhibitors within 4 weeks prior to dosing (see Appendix 2).
12. 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
13. History of drug abuse within 6 months prior to screening, or positive result for any drug abuse test.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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
19. Corrected QT interval (using Fridericia's formula, QTcF = QT/(RR\^0.33)) \> 450 msec in males or females.
20. 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.
21. 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
22. Pregnant or lactating females.
23. Special dietary requirements or inability to comply with standardized diet.
24. 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.
25. 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.
26. Other conditions deemed unsuitable for participation in this study by the investigator.
Where this trial is running
Beijing
- Peking University Third Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Yulan Chen
- Email: chenyulan@cms.net.cn
- Phone: +86 10 6400 9673
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.