CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 80 enrolled
Drug / intervention
REGN7508 (IV) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05603195
NCT05603195Phase 1Completed

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

Regeneron Pharmaceuticals·interventional·Posted Nov 2, 2022·Updated Oct 1, 2024

In Brief

A Phase 1 clinical trial evaluating REGN7508 (IV), REGN7508 (SC), and 2 other interventions for Healthy Volunteer. Completed, enrolled 80 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedNov 2, 2022
Enrollment StartJan 12, 2023
Primary CompletionSep 17, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 3.7 years ago

Interventions

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