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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

NCT05603195 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-10-01

No results posted yet for this study

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)

Conditions

  • Healthy Volunteer

Interventions

DRUG

REGN7508 (IV)

Administered sequential, ascending single intravenous (IV) dose

DRUG

REGN7508 (SC)

Administered sequential, ascending single subcutaneous (SC) dose

DRUG

Matching Placebo (IV)

Administered sequential, ascending single intravenous (IV) dose

DRUG

Matching Placebo (SC)

Administered sequential, ascending single subcutaneous (SC) dose

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-01-12
Primary Completion
2024-09-17
Completion
2024-09-17
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT05603195 on ClinicalTrials.gov