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New treatment option for Paroxysmal Nocturnal Hemoglobinuria, PNH
Official title A Phase I Clinical Trial to Evaluate CMS-D017 Following Single and Multiple Doses in Healthy Participants
ClinicalTrials.gov ID: NCT07462780
What this study is testing
What is CMS-D017 Capsule?
CMS-D017 Capsule is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for paroxysmal nocturnal hemoglobinuria, pnh.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Any condition that may affect drug absorption, including but not limited to: malabsorption syndrome, inflammatory bowel disease, celiac disease...
- 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.
See the full eligibility criteria
Who can join
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.