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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05603195
• Other study ID #: R7508-HV-21102
• Secondary ID: 2022-002001-20
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 12, 2023
• Est. completion date: September 24, 2024

Study information

• Verified date: June 2024
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: September 24, 2024
• Est. primary completion date: September 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

1. Body mass index between 18.0 and 32.5 kg/m2 (inclusive) at the screening visit

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

Key Exclusion Criteria:

1. 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

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

NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United Kingdom	Labcorp Clinical Research Unit	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change from baseline in activated partial thromboplastin time (aPTT)		Up to 36 days
Secondary	Change from baseline in prothrombin time (PT)		Up to 36 days
Secondary	Concentrations of total REGN7508 in serum		Up to 36 days
Secondary	Concentrations of functional REGN7508 in plasma		Up to 36 days
Secondary	Absolute concentration and change from baseline in total Factor XI (FXI) concentrations		Up to 36 days
Secondary	Absolute concentration and change from baseline in free FXI concentrations		Up to 36 days
Secondary	Incidence of antidrug antibodies (ADAs) to REGN7508 over time		Up to 36 days