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

NCT05102136 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-05-03

No results posted yet for this study

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

Interventions

DRUG

REGN9933

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2023-04-04
Completion
2023-04-04

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05102136 on ClinicalTrials.gov