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Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of the Monoclonal Antibody PGT121.414.LS Administered Alone and in Combination With VRC07-523LS Via Intravenous or Subcutaneous Infusions in Healthy, HIV-uninfected Adult Participants

NCT04212091 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-12-13

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous or subcutaneous infusions in healthy, HIV-uninfected adult participants.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

PGT121.414.LS

Administered via IV infusion or SC infusion, depending on the arm

BIOLOGICAL

VRC07-523LS

Administered via IV infusion or SC infusion, depending on the arm

Sponsors & Collaborators

  • HIV Vaccine Trials Network

    collaborator NETWORK

  • HIV Prevention Trials Network

    collaborator NETWORK

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Christopher Hurt · University of North Carolina, Chapel Hill

  • Kathryn Stephenson · Beth Israel Deaconess Medical Center, Harvard University

  • Srilatha Edupuganti · Emory University

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
2020-11-10
Primary Completion
2023-01-18
Completion
2023-01-18
FDA Drug
Yes

Countries

  • United States

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 NCT04212091 on ClinicalTrials.gov