A Trial to Learn if Single Ascending Intravenous (IV) Doses of REGN7508 Are Safe and Well Tolerated, and How it Works in the Body of Healthy Adult Participants
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Drug: REGN7508 (IV)Drug: REGN7508 (SC)Drug: Matching Placebo (SC)Drug: Matching Placebo (IV)
- Registration Number
- NCT05603195
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
This study is researching an experimental drug called REGN7508 (called "study drug"). The aim of this study is to see how safe and tolerable the study drug is in healthy participants.
This study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Body mass index between 18.0 and 32.5 kg/m2 (inclusive) at the screening visit
- Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and echocardiograms (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
- Normal activated partial thromboplastin time (aPTT), normal prothrombin time (PT), and normal platelet counts at screening period and at the day -1 visit as defined by the local laboratory
- Hemoglobin value ≥11.0 g/dL for females and ≥12.9 g/dL for males at the screening and day 1 visits
Key
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 participant by study participation
- Whole blood donation within the previous 56 days or plasma donation within the previous 7 days prior to the screening visit
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological, or dermatologic 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, as defined in the protocol
- Estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73m2 at screening
- 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 the screening visit
- History of alcohol abuse within the last 2 years prior to the day 1 visit
- Any malignancy, except for nonmelanoma 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
- History of significant multiple and/or severe allergies (eg, latex gloves) or has had an anaphylactic reaction to prescription or nonprescription drugs or food
NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 5 Higher IV Dose REGN7508 (IV) Randomized 3:1 Cohort 6 High SC Dose Matching Placebo (SC) Randomized 3:1 Cohort 7 Higher SC Dose REGN7508 (SC) Randomized 3:1 Cohort 7 Higher SC Dose Matching Placebo (SC) Randomized 3:1 Cohort 1 Lowest IV Dose REGN7508 (IV) Randomized 3:1 Cohort 1 Lowest IV Dose Matching Placebo (IV) Randomized 3:1 Cohort 2 Low IV Dose REGN7508 (IV) Randomized 3:1 Cohort 2 Low IV Dose Matching Placebo (IV) Randomized 3:1 Cohort 3 Mid IV Dose REGN7508 (IV) Randomized 3:1 Cohort 3 Mid IV Dose Matching Placebo (IV) Randomized 3:1 Cohort 4 High IV Dose REGN7508 (IV) Randomized 3:1 Cohort 4 High IV Dose Matching Placebo (IV) Randomized 3:1 Cohort 5 Higher IV Dose Matching Placebo (IV) Randomized 3:1 Cohort 6 High SC Dose REGN7508 (SC) Randomized 3:1 Optional: Cohort 8 Highest IV or SC Dose REGN7508 (IV) Randomized 3:1 Optional: Cohort 8 Highest IV or SC Dose REGN7508 (SC) Randomized 3:1 Optional: Cohort 8 Highest IV or SC Dose Matching Placebo (IV) Randomized 3:1 Optional: Cohort 8 Highest IV or SC Dose Matching Placebo (SC) Randomized 3:1 Cohort 9 High SC Dose REGN7508 (SC) Randomized 3:1 Cohort 9 High SC Dose Matching Placebo (SC) Randomized 3:1 Optional: Cohort 10 Highest SC Dose REGN7508 (SC) Randomized 3:1 Optional: Cohort 10 Highest SC Dose Matching Placebo (SC) Randomized 3:1
- Primary Outcome Measures
Name Time Method Incidences of treatment-emergent adverse events (TEAE) Up to 36 days Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
Severity of TEAE Up to 36 days Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
- Secondary Outcome Measures
Name Time Method Change from baseline in activated partial thromboplastin time (aPTT) Up to 36 days Change from baseline in prothrombin time (PT) Up to 36 days Concentrations of total REGN7508 in serum Up to 36 days Concentrations of functional REGN7508 in plasma Up to 36 days Absolute concentration and change from baseline in total Factor XI (FXI) concentrations Up to 36 days Absolute concentration and change from baseline in free FXI concentrations Up to 36 days Incidence of antidrug antibodies (ADAs) to REGN7508 over time Up to 36 days
Trial Locations
- Locations (1)
Labcorp Clinical Research Unit
🇬🇧Leeds, United Kingdom