Phase 1 Safety and Tolerability Study of REGN9533 in Healthy Adults

Launched by REGENERON PHARMACEUTICALS · Oct 28, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new drug called REGN9533 in healthy adults to see how safe it is and how well the body can tolerate it. Since this is the first time REGN9533 is being given to people, researchers will closely monitor any side effects, how the body processes the drug, and whether the immune system reacts to it. The results of this trial will help determine the best dose of REGN9533 and prepare for future studies involving people with blood vessel blockages, like blood clots.

To participate in this trial, you need to be between 18 and 65 years old and in good health. The study will require some medical tests to make sure you don’t have any major health issues or a history of significant bleeding problems. Participants can expect to undergo regular check-ups and tests during the study to monitor their health and how they respond to the drug. This trial is an important step in understanding REGN9533 and its potential benefits for future patients.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Has a body mass index between 18 and 32 kg/m2, inclusive
• • 2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed at screening and/or prior to administration of initial dose of study drug
• • 3. Normal aPTT, normal PT, and normal platelet counts as described in the protocol
• • 4. Hemoglobin values at screening period and at day -1 as described in the protocol
• • 5. Negative Fecal Occult Blood Test (FOBT) during screening period
• • 6. Normal Bleeding Time Test (BTT) at day -1 as defined by the study site
• Key Exclusion Criteria:
• • 1. History of any major surgical procedure or clinically significant physical trauma within the last 6 months that in the opinion of the investigator may pose a risk to the participant by study participation
• • 2. History of clinically significant bleeding, requiring hospitalization or blood products within the last 6 months, that in the opinion of the investigator may pose a risk to the participant by study participation
• • 3. History of bleeding diathesis (eg, including, but not limited to Hemophilia A or B, von Willebrand's Factor deficiency, fibrinogen deficiency, and other inherited or acquired bleeding disorders)
• • 4. History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, as assessed by the investigator, that may confound the results of the study or poses an additional risk to the participant by study participation
• • 5. Is a current smoker including e-cigarettes or other nicotine-containing products; or is a former smoker including e-cigarettes or other nicotine-containing products which they have used at any time within 3 months prior to the screening visit
• • 6. Has a confirmed positive drug test result at the screening visit and/or prior to randomization; or a history of recreational drug use (eg, marijuana) and/or drug or alcohol abuse within a year prior to the screening visit
• • 7. Any malignancy, except for non-melanoma skin cancer or cervical/anus in-situ, that have been resected with no evidence of metastatic disease for 3 years prior to the screening visit
• • 8. Has a history of significant multiple and/or severe allergies (eg, latex gloves), or has had an anaphylactic reaction to prescription or non-prescription drugs or food
• • Note: Other protocol-defined Inclusion/Exclusion Criteria apply