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Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Combinations of Monoclonal Antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS Administered Via Intravenous Infusion in Healthy, HIV-uninfected Adult Participants

NCT03928821 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-07-11

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion in healthy, HIV-uninfected adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

PGT121

20 mg/kg administered intravenously

BIOLOGICAL

PGDM1400

20 mg/kg administered intravenously

BIOLOGICAL

10-1074

20 mg/kg administered intravenously

BIOLOGICAL

VRC07-523LS

20 mg/kg administered intravenously

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Magdalena Sobieszczyk · Columbia University

  • Sharon Mannheimer · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2021-03-25
Completion
2021-03-25
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 NCT03928821 on ClinicalTrials.gov