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Completed

NCT Number: NCT05102136

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9933 in Adult Healthy Volunteers

The primary objective of the study is to evaluate the safety and tolerability of single doses of REGN9933 in healthy participants

The secondary objectives of the study are to:

* Evaluate the effects of single doses of REGN9933 on intrinsic/common pathway coagulation * Evaluate the effects of single doses of REGN9933 on extrinsic/common pathway coagulation * Characterize the drug concentration profiles and pharmacokinetic (PK) following single escalating doses of REGN9933 * Characterize the concentration profiles of total FXI following single escalating doses of REGN9933 * Assess the immunogenicity of single doses of REGN9933

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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

Regeneron Study Site

Edegem, Antwerp, B-2650, Belgium

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 kilograms/per metered squared (kg/m^2) (inclusive) at the screening visit.
  • Judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiogram (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. Note :Participant with suspected or confirmed Gilbert's disease can be enrolled in the study.
  • Normal activated partial thromboplastin time (aPTT), normal prothrombin time (PT), and normal platelet counts at screening period and at day -1 as defined by the local laboratory
  • Hemoglobin value ≥11.0 grams per deciliter (g/dL) for females and ≥12.9 g/dL for males at screening and day -1
  • Negative fecal occult blood test (FOBT) during screening period
  • Normal Bleeding time test (BTT) at day -1 as defined by the study site

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 subject by study participation.
  • Whole blood donation within the previous 56 days or plasma donation within the previous 7 days prior to screening
  • Pregnant or breastfeeding women
  • History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, neurological, or dermatologic disease, as assessed by the investigator
  • Hospitalized for any reason within 30 days of the screening visit.
  • 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 screening.
  • History of alcohol abuse within the last 2 years prior to dosing
  • Positive for human immunodeficiency virus (HIV), hepatitis B, or and/or hepatitis C per protocol resolved hepatitis B infection is not an exclusion.
  • 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
  • Women of child bearing potential (defined as women who are fertile, following menarche until becoming postmenopausal, unless permanently surgically sterile. The only allowed permanent sterilization methods for this study are hysterectomy and/or bilateral oophorectomy.)

Note: Other protocol defined inclusion/exclusion criteria apply.

Treatment and study plan

REGN9933

Drug

Administered intravenously (IV) or subcutaneous (SC) per the protocol

Placebo

Drug

Placebo to match REGN9933 in same form; placebo administered IV or SC per the protocol

Primary outcomes

  1. Incidence and severity of treatment emergent adverse events (TEAE)

    Time frame: Until resolution of pharmacodynamic (PD) effects; approximately 36 days

Secondary outcomes

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

    Time frame: Until resolution of PD effects; approximately 36 days

  2. Change from baseline in prothrombin time (PT)

    Time frame: Until resolution of PD effects; approximately 36 days

  3. Concentration of REGN9933 in serum

    Time frame: Until resolution of PD effects; approximately 36 days

  4. Change from baseline in total Factor XI (FXI) concentrations

    Time frame: Until resolution of PD effects; approximately 36 days

  5. The incidence of antidrug antibodies (ADAs) to REGN9933 over time

    Time frame: Until resolution of PD effects; approximately 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 REGN9933, a Monoclonal Antibody Against Factor XI, in Healthy Adult Subjects

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 1, 2021
Registry last updated
May 3, 2023

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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