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

Sponsor

Regeneron Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05603195

Collaborator

(none)

Enrollment

Location

Arms

14.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate the safety and tolerability of single doses of REGN7508 in healthy adult participants

The secondary objectives of the study are to:

Evaluate the effects of single doses of REGN7508 on intrinsic/common pathway coagulation
Evaluate the effects of single doses of REGN7508 on extrinsic/common pathway coagulation
Characterize the drug concentration profiles and pharmacokinetics (PK) following single escalating doses of REGN7508
Characterize the concentration profiles of total Factor XI (FXI) following single escalating doses of REGN7508
Assess the immunogenicity of single doses of REGN7508

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: REGN7508 (IV) Drug: REGN7508 (SC) Drug: Matching Placebo (IV) Drug: Matching Placebo (SC)	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of REGN7508, a Monoclonal Antibody Against Factor XI, in Healthy Adult Subjects

Actual Study Start Date :

Jan 12, 2023

Anticipated Primary Completion Date :

Mar 27, 2024

Anticipated Study Completion Date :

Mar 27, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 Lowest IV Dose Randomized 3:1	Drug: REGN7508 (IV) Administered sequential, ascending single intravenous (IV) dose Drug: Matching Placebo (IV) Administered sequential, ascending single intravenous (IV) dose
Experimental: Cohort 2 Low IV Dose Randomized 3:1	Drug: REGN7508 (IV) Administered sequential, ascending single intravenous (IV) dose Drug: Matching Placebo (IV) Administered sequential, ascending single intravenous (IV) dose
Experimental: Cohort 3 Mid IV Dose Randomized 3:1	Drug: REGN7508 (IV) Administered sequential, ascending single intravenous (IV) dose Drug: Matching Placebo (IV) Administered sequential, ascending single intravenous (IV) dose
Experimental: Cohort 4 High IV Dose Randomized 3:1	Drug: REGN7508 (IV) Administered sequential, ascending single intravenous (IV) dose Drug: Matching Placebo (IV) Administered sequential, ascending single intravenous (IV) dose
Experimental: Cohort 5 Higher IV Dose Randomized 3:1	Drug: REGN7508 (IV) Administered sequential, ascending single intravenous (IV) dose Drug: Matching Placebo (IV) Administered sequential, ascending single intravenous (IV) dose
Experimental: Cohort 6 High SC Dose Randomized 3:1 SC Dose Cohort will be initiated only after an equivalent or higher IV Dose level has been evaluated. SC Cohort 6 and 7 may be activated prior to IV Dose Cohort 5.	Drug: REGN7508 (SC) Administered sequential, ascending single subcutaneous (SC) dose Drug: Matching Placebo (SC) Administered sequential, ascending single subcutaneous (SC) dose
Experimental: Cohort 7 Higher SC Dose Randomized 3:1 SC Dose Cohort will be initiated only after an equivalent or higher IV Dose level has been evaluated. SC Cohort 6 and 7 may be activated prior to IV Dose Cohort 5.	Drug: REGN7508 (SC) Administered sequential, ascending single subcutaneous (SC) dose Drug: Matching Placebo (SC) Administered sequential, ascending single subcutaneous (SC) dose
Experimental: Optional: Cohort 8 Highest IV or SC Dose Randomized 3:1	Drug: REGN7508 (IV) Administered sequential, ascending single intravenous (IV) dose Drug: REGN7508 (SC) Administered sequential, ascending single subcutaneous (SC) dose Drug: Matching Placebo (IV) Administered sequential, ascending single intravenous (IV) dose Drug: Matching Placebo (SC) Administered sequential, ascending single subcutaneous (SC) dose
Experimental: Optional: Cohort 9 Highest IV or SC Dose Randomized 3:1	Drug: REGN7508 (IV) Administered sequential, ascending single intravenous (IV) dose Drug: REGN7508 (SC) Administered sequential, ascending single subcutaneous (SC) dose Drug: Matching Placebo (IV) Administered sequential, ascending single intravenous (IV) dose Drug: Matching Placebo (SC) Administered sequential, ascending single subcutaneous (SC) dose

Outcome Measures

Primary Outcome Measures

Incidences of treatment-emergent adverse events (TEAE) [Through the End of Outpatient Clinical Follow-up (EOF), Approximately 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 [Through the EOF, Approximately 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

Change from baseline in activated partial thromboplastin time (aPTT) [Baseline Through EOF, Approximately 36 Days]
Change from baseline in prothrombin time (PT) [Baseline Through EOF, Approximately 36 Days]
Concentrations of REGN7508 in serum [Through the EOF, Approximately 36 Days]
Change from baseline in total Factor XI (FXI) concentrations [Baseline Through the EOF, Approximately 36 Days]
Incidence of antidrug antibodies (ADAs) to REGN7508 over time [Through the EOF, Approximately 36 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Key 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Labcorp Clinical Research Unit	Leeds		United Kingdom	LS2 9LH

Sponsors and Collaborators

Regeneron Pharmaceuticals

Investigators

Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Regeneron Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT05603195

Other Study ID Numbers:

R7508-HV-21102
2022-002001-20

First Posted:

Nov 2, 2022

Last Update Posted:

Feb 1, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Regeneron Pharmaceuticals

Thrombotic disorders

Study Results

No Results Posted as of Feb 1, 2023