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
NCT ID: NCT05603195
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2023-01-12
2024-09-17
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Cohort 1 Lowest IV Dose
Randomized 3:1
REGN7508 (IV)
Administered sequential, ascending single intravenous (IV) dose
Matching Placebo (IV)
Administered sequential, ascending single intravenous (IV) dose
Cohort 2 Low IV Dose
Randomized 3:1
REGN7508 (IV)
Administered sequential, ascending single intravenous (IV) dose
Matching Placebo (IV)
Administered sequential, ascending single intravenous (IV) dose
Cohort 3 Mid IV Dose
Randomized 3:1
REGN7508 (IV)
Administered sequential, ascending single intravenous (IV) dose
Matching Placebo (IV)
Administered sequential, ascending single intravenous (IV) dose
Cohort 4 High IV Dose
Randomized 3:1
REGN7508 (IV)
Administered sequential, ascending single intravenous (IV) dose
Matching Placebo (IV)
Administered sequential, ascending single intravenous (IV) dose
Cohort 5 Higher IV Dose
Randomized 3:1
REGN7508 (IV)
Administered sequential, ascending single intravenous (IV) dose
Matching Placebo (IV)
Administered sequential, ascending single intravenous (IV) dose
Cohort 6 High SC Dose
Randomized 3:1
REGN7508 (SC)
Administered sequential, ascending single subcutaneous (SC) dose
Matching Placebo (SC)
Administered sequential, ascending single subcutaneous (SC) dose
Cohort 7 Higher SC Dose
Randomized 3:1
REGN7508 (SC)
Administered sequential, ascending single subcutaneous (SC) dose
Matching Placebo (SC)
Administered sequential, ascending single subcutaneous (SC) dose
Optional: Cohort 8 Highest IV or SC Dose
Randomized 3:1
REGN7508 (IV)
Administered sequential, ascending single intravenous (IV) dose
REGN7508 (SC)
Administered sequential, ascending single subcutaneous (SC) dose
Matching Placebo (IV)
Administered sequential, ascending single intravenous (IV) dose
Matching Placebo (SC)
Administered sequential, ascending single subcutaneous (SC) dose
Cohort 9 High SC Dose
Randomized 3:1
REGN7508 (SC)
Administered sequential, ascending single subcutaneous (SC) dose
Matching Placebo (SC)
Administered sequential, ascending single subcutaneous (SC) dose
Optional: Cohort 10 Highest SC Dose
Randomized 3:1
REGN7508 (SC)
Administered sequential, ascending single subcutaneous (SC) dose
Matching Placebo (SC)
Administered sequential, ascending single subcutaneous (SC) dose
Interventions
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REGN7508 (IV)
Administered sequential, ascending single intravenous (IV) dose
REGN7508 (SC)
Administered sequential, ascending single subcutaneous (SC) dose
Matching Placebo (IV)
Administered sequential, ascending single intravenous (IV) dose
Matching Placebo (SC)
Administered sequential, ascending single subcutaneous (SC) dose
Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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
4. 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
5. Hemoglobin value ≥11.0 g/dL for females and ≥12.9 g/dL for males at the screening and day 1 visits
Exclusion Criteria
2. Whole blood donation within the previous 56 days or plasma donation within the previous 7 days prior to the screening visit
3. 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
4. Estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73m2 at screening
5. Current smoker or former smoker, including e-cigarettes, who stopped smoking within 12 months prior to the screening visit
6. 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
7. History of alcohol abuse within the last 2 years prior to the day 1 visit
8. 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
9. History of significant multiple and/or severe allergies (eg, latex gloves) or has had an anaphylactic reaction to prescription or nonprescription drugs or food
18 Years
55 Years
ALL
Yes
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Labcorp Clinical Research Unit
Leeds, , United Kingdom
Countries
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Other Identifiers
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2022-002001-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R7508-HV-21102
Identifier Type: -
Identifier Source: org_study_id
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