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

NCT05603195 | Completed Phase 1 FDA Drug

• 2 other identifiers: R7508-HV-211022022-002001-20
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Conditions

Healthy Volunteer

Keywords

Thrombotic disorders

Outcome Measures

Primary Outcomes (2)

• Incidences of treatment-emergent adverse events (TEAE)

  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.

  Up to 36 days

• Severity of TEAE

  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.

  Up to 36 days

Secondary Outcomes (7)

• 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

Study Arms (10)

Cohort 1 Lowest IV Dose

EXPERIMENTAL

Randomized 3:1

Drug: REGN7508 (IV); Drug: Matching Placebo (IV)

Cohort 2 Low IV Dose

EXPERIMENTAL

Randomized 3:1

Drug: REGN7508 (IV); Drug: Matching Placebo (IV)

Cohort 3 Mid IV Dose

EXPERIMENTAL

Randomized 3:1

Drug: REGN7508 (IV); Drug: Matching Placebo (IV)

Cohort 4 High IV Dose

EXPERIMENTAL

Randomized 3:1

Drug: REGN7508 (IV); Drug: Matching Placebo (IV)

Cohort 5 Higher IV Dose

EXPERIMENTAL

Randomized 3:1

Drug: REGN7508 (IV); Drug: Matching Placebo (IV)

Cohort 6 High SC Dose

EXPERIMENTAL

Randomized 3:1

Drug: REGN7508 (SC); Drug: Matching Placebo (SC)

Cohort 7 Higher SC Dose

EXPERIMENTAL

Randomized 3:1

Drug: REGN7508 (SC); Drug: Matching Placebo (SC)

Optional: Cohort 8 Highest IV or SC Dose

EXPERIMENTAL

Randomized 3:1

Drug: REGN7508 (IV); Drug: REGN7508 (SC); Drug: Matching Placebo (IV); Drug: Matching Placebo (SC)

Cohort 9 High SC Dose

EXPERIMENTAL

Randomized 3:1

Drug: REGN7508 (SC); Drug: Matching Placebo (SC)

Optional: Cohort 10 Highest SC Dose

EXPERIMENTAL

Randomized 3:1

Drug: REGN7508 (SC); Drug: Matching Placebo (SC)

Interventions

REGN7508 (IV) DRUG

Administered sequential, ascending single intravenous (IV) dose

Cohort 1 Lowest IV Dose; Cohort 2 Low IV Dose; Cohort 3 Mid IV Dose; Cohort 4 High IV Dose; Cohort 5 Higher IV Dose; Optional: Cohort 8 Highest IV or SC Dose

REGN7508 (SC) DRUG

Administered sequential, ascending single subcutaneous (SC) dose

Cohort 6 High SC Dose; Cohort 7 Higher SC Dose; Cohort 9 High SC Dose; Optional: Cohort 10 Highest SC Dose; Optional: Cohort 8 Highest IV or SC Dose

Matching Placebo (IV) DRUG

Administered sequential, ascending single intravenous (IV) dose

Cohort 1 Lowest IV Dose; Cohort 2 Low IV Dose; Cohort 3 Mid IV Dose; Cohort 4 High IV Dose; Cohort 5 Higher IV Dose; Optional: Cohort 8 Highest IV or SC Dose

Matching Placebo (SC) DRUG

Administered sequential, ascending single subcutaneous (SC) dose

Cohort 6 High SC Dose; Cohort 7 Higher SC Dose; Cohort 9 High SC Dose; Optional: Cohort 10 Highest SC Dose; Optional: Cohort 8 Highest IV or SC Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Labcorp Clinical Research Unit

Leeds, LS2 9LH, United Kingdom

Location

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 2, 2022
• Study Start: January 12, 2023
• Primary Completion: September 17, 2024
• Study Completion: September 17, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

GB (1)