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

NCT05102136 | Completed Phase 1

• 2 other identifiers: R9933-HV-21072021-002568-34
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

HV

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment emergent adverse events (TEAE)

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

Secondary Outcomes (5)

• Change from baseline in activated partial thromboplastin time (aPTT)

  Until resolution of PD effects; approximately 36 days

• Change from baseline in prothrombin time (PT)

  Until resolution of PD effects; approximately 36 days

• Concentration of REGN9933 in serum

  Until resolution of PD effects; approximately 36 days

• Change from baseline in total Factor XI (FXI) concentrations

  Until resolution of PD effects; approximately 36 days

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

  Until resolution of PD effects; approximately 36 days

Study Arms (2)

Intravenous Cohorts

EXPERIMENTAL

Randomized 6:2 to REGN9933 or placebo

Drug: REGN9933; Drug: Placebo

Subcutaneous Cohorts

EXPERIMENTAL

Randomized 6:2 to REGN9933 or placebo

Drug: REGN9933; Drug: Placebo

Interventions

REGN9933 DRUG

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

Intravenous Cohorts; Subcutaneous Cohorts

Placebo DRUG

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

Intravenous Cohorts; Subcutaneous Cohorts

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 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

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 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
• 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.)

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

Regeneron Study Site

Edegem, Antwerp, B-2650, Belgium

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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 1, 2021
• Study Start: October 27, 2021
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-04

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

BE (1)