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Evaluating the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibodies in Healthy Participants

NCT05959707 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2024-07-05

No results posted yet for this study

Summary

Part A:

The purpose of this part is to study how the body's immune system reacts to a lab-made HIV-1 monoclonal antibody against HIV antigen when given in different doses. The study will also evaluate if the antibody is safe to give to people and does not make them too uncomfortable.

Part B:

The purpose of this part is to study how the body's immune system reacts to a combination of lab-made HIV-1 monoclonal antibodies against HIV antigens when given in different doses. The study also wants to see if the way the antibodies are given affects the immune response.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

VRC01.23LS

VRC01.23LS will be administered IV over approximately 30 to 60 minutes.

BIOLOGICAL

PGT121.414.LS

PGT121.414.LS will be administered IV over approximately 30 to 60 minutes.

BIOLOGICAL

PGDM1400LS

PGDM1400LS will be administered IV over approximately 30 to 60 minutes.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • HIV Vaccine Trials Network

    lead NETWORK

Principal Investigators

  • Hyman Scott · Bridge HIV

  • Cynthia Gay · University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-08-14
Primary Completion
2025-01-14
Completion
2025-01-14

Countries

  • South Africa

Study Locations

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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 NCT05959707 on ClinicalTrials.gov