NCT05184452 - A Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of PGDM1400LS Alone and in Combination With VRC07-523LS and PGT121.414.LS in Healthy, HIV-uninfected Adult Participants | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 15, 2021

Primary Completion Date

July 19, 2023

Study Completion Date

July 19, 2023

Conditions

HIV Infections

Interventions

DRUG

PGDM1400LS (5mg/kg, IV)

5 mg/kg to be administered via IV infusion

DRUG

PGDM1400LS (20mg/kg, IV)

20 mg/kg to be administered via IV infusion

DRUG

PGDM1400LS (20mg/kg, SC)

20 mg/kg to be administered via SC infusion

DRUG

PGDM1400LS (40mg/kg, IV)

40 mg/kg to be administered via IV infusion

DRUG

PGDM1400LS (40mg/kg, SC)

40 mg/kg to be administered via SC infusion

DRUG

PGDM1400LS (1.4g, IV)

1.4gram to be administered via IV infusion

DRUG

PGDM1400LS (1.4g, SC)

1.4gram to be administered via SC infusion

DRUG

VRC07-523LS (20mg/kg, IV)

VRC07-523LS 20mg/kg administered via IV infusion

DRUG

VRC07-523LS (20mg/kg, SC)

VRC07-523LS 20mg/kg administered via SC infusion

DRUG

VRC07-523LS (1.4g, IV)

VRC07-523LS 1.4g administered via IV infusion

DRUG

VRC07-523LS (1.4g, SC)

VRC07-523LS 1.4g administered via SC infusion

DRUG

VRC07-523LS (40mg/kg, IV)

VRC07-523LS 40mg/kg administered via IV infusion

DRUG

PGT121.414.LS (20mg/kg, IV)

PGT121.414.LS 20mg/kg administered via IV infusion

DRUG

PGT121.414.LS (20mg/kg, SC)

PGT121.414.LS 20mg/kg administered via SC infusion

DRUG

PGT121.414.LS (1.4g, IV)

PGT121.414.LS 1.4g administered via IV infusion

DRUG

PGT121.414.LS (1.4g, SC)

PGT121.414.LS 1.4g administered via SC infusion

DRUG

PGT121.414.LS (40mg/kg, IV)

PGT121.414.LS 40mg/kg administered via IV infusion

Trial Locations (13)

1862

Soweto HVTN CRS, Soweto

2001

Ward 21 Clinical Research Site, Hillbrow

4001

CAPRISA eThekweni Clinical Research Site, Berea

7925

Groote Schuur Hospital, Cape Town

30030

The Hope Clinic of the Emory Vaccine Center, Atlanta

37232

Vanderbilt Vaccine (VV), Nashville

94102

Bridge HIV CRS, San Francisco

20037-1894

George Washington University, Washington D.C.

07103

New Jersey Medical School Clinical Research Center CRS, Newark

Unknown

Kenya Medical Research Institute (KEMRI), Kericho

Seke South Clinical Research Site, Chitungwiza

Milton Park CRS, Milton Park

Spilhaus CRS, Milton Park

All Listed Sponsors

collaborator

National Institutes of Health (NIH)

NIH

collaborator

Department of Health and Human Services

FED

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH