Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9933 in… (NCT05102136) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9933 in Adult Healthy Volunteers
Belgium56 participantsStarted 2021-10-27
Plain-language summary
The primary objective of the study is to evaluate the safety and tolerability of single doses of REGN9933 in healthy participants
The secondary objectives of the study are to:
* Evaluate the effects of single doses of REGN9933 on intrinsic/common pathway coagulation
* Evaluate the effects of single doses of REGN9933 on extrinsic/common pathway coagulation
* Characterize the drug concentration profiles and pharmacokinetic (PK) following single escalating doses of REGN9933
* Characterize the concentration profiles of total FXI following single escalating doses of REGN9933
* Assess the immunogenicity of single doses of REGN9933
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Body mass index between 18.0 and 32.5 kilograms/per metered squared (kg/m\^2) (inclusive) at the screening visit.
. Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram (ECGs) performed at screening and/or prior to administration of initial dose of study drug.
. Participant is in good health based on laboratory safety testing obtained at the screening visit and/or prior to administration of initial dose of study drug. Note :Participant with suspected or confirmed Gilbert's disease can be enrolled in the study.
. Normal activated partial thromboplastin time (aPTT), normal prothrombin time (PT), and normal platelet counts at screening period and at day -1 as defined by the local laboratory
. Hemoglobin value ≥11.0 grams per deciliter (g/dL) for females and ≥12.9 g/dL for males at screening and day -1
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of treatment emergent adverse events (TEAE)
Timeframe: Until resolution of pharmacodynamic (PD) effects; approximately 36 days
. Negative fecal occult blood test (FOBT) during screening period
. Normal Bleeding time test (BTT) at day -1 as defined by the study site
Exclusion criteria
. History of any major surgical procedure or clinically significant physical trauma, in the opinion of the investigator, that may pose a risk to the subject by study participation.
. Whole blood donation within the previous 56 days or plasma donation within the previous 7 days prior to screening
. Pregnant or breastfeeding women
. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological, or dermatologic disease, as assessed by the investigator
. Hospitalized for any reason within 30 days of the screening visit.
. Current smoker or former smoker, including e-cigarettes, who stopped smoking within 12 months prior to the screening visit
. Confirmed positive drug test result at the screening visit and/or prior to randomization or a history of drug abuse within a year prior to screening.
. History of alcohol abuse within the last 2 years prior to dosing