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OpenTrials
Completed

NCT Number: NCT05603195

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

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)

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Labcorp Clinical Research Unit

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REGN7508 (IV)

Drug

Administered sequential, ascending single intravenous (IV) dose

REGN7508 (SC)

Drug

Administered sequential, ascending single subcutaneous (SC) dose

Matching Placebo (IV)

Drug

Administered sequential, ascending single intravenous (IV) dose

Matching Placebo (SC)

Drug

Administered sequential, ascending single subcutaneous (SC) dose

Primary outcomes

  1. Incidences of treatment-emergent adverse events (TEAE)

    Time frame: 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.

  2. Severity of TEAE

    Time frame: 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 outcomes

  1. Change from baseline in activated partial thromboplastin time (aPTT)

    Time frame: Up to 36 days

  2. Change from baseline in prothrombin time (PT)

    Time frame: Up to 36 days

  3. Concentrations of total REGN7508 in serum

    Time frame: Up to 36 days

  4. Concentrations of functional REGN7508 in plasma

    Time frame: Up to 36 days

  5. Absolute concentration and change from baseline in total Factor XI (FXI) concentrations

    Time frame: Up to 36 days

  6. Absolute concentration and change from baseline in free FXI concentrations

    Time frame: Up to 36 days

  7. Incidence of antidrug antibodies (ADAs) to REGN7508 over time

    Time frame: Up to 36 days

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 2, 2022
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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