RecruitingPhase 1

A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1

United States, Peru, Zimbabwe83 participantsStarted 2026-03-19

Plain-language summary

This study is testing a lab-made antibody called ePGT121v1-LS that targets a specific part of HIV. Researchers will give it by vein (IV) and under the skin (SC), both on its own and together with two other antibodies, VRC07-523LS and PGDM1400LS, which target different parts of the virus. They will assess safety and side effects, determine the right dose, study how the body processes the drug (pharmacokinetics or PK), and measure how well it neutralizes HIV in the blood (serum neutralizing activity). The expectation is that ePGT121v1-LS, whether given alone or with PGDM1400LS and VRC07-523LS, by IV or SC, will be safe in generally healthy adults and that the antibodies will not interfere with each other when used together. Approximately 83 volunteers in overall good health and without HIV-1 will be enrolled into two parts (A and B). Part A has six groups. In Groups 1-3, participants will get ePGT121v1-LS given by IV at one of three dose levels: 5 mg/kg, 20 mg/kg, or 40 mg/kg. In Groups 4-6, participants will receive three antibodies-first ePGT121v1-LS, then PGDM1400LS and VRC07-523LS-given by IV at two separate visits that are 24 weeks apart. The total study duration for participants in Part A is 48 weeks of scheduled clinic visits. Part B has two groups. In Group 7, people will get ePGT121v1-LS as SC shots at two visits 12 weeks apart. Each visit will give a total of 375 mg, split into three injections of 125 mg each. In Group 8, people will also have two visits 12 weeks apart and will receive three antibodies as SC shots in this order: first ePGT121v1-LS (125 mg), then PGDM1400LS (100 mg), and then VRC07-523LS (100 mg). The total study duration for participants in Part B is 24 weeks of scheduled clinic visits.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18 to 55 years.
. Can visit a participating clinic and is willing to stay in the study for its full duration.
. Understands the study and is able and willing to give informed consent.
. Agrees not to join another experimental study until the final required clinic visit.
. In good overall health based on medical history, physical exam, and screening lab tests.
. Willing to receive HIV test results.
. Willing to discuss personal risk of getting HIV and to have HIV prevention counseling.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A: Number of participants with solicited local Adverse Events (AEs)

Timeframe: Baseline through Week 48

Part B: Number of participants with solicited local Adverse Events (AEs)

Timeframe: Baseline through Week 24

Part A: Percentage of participants with solicited local Adverse Events (AEs)

Timeframe: Baseline through Week 48

Part B: Percentage of participants with solicited local Adverse Events (AEs)

Timeframe: Baseline through Week 24

Part A: Number of participants with solicited systemic AEs

Timeframe: Baseline through Week 48

Part B: Number of participants with solicited systemic AEs

Timeframe: Baseline through Week 24

Part A: Percentage of participants with solicited systemic AEs

Timeframe: Baseline through Week 48

Trial details

NCT IDNCT07390955

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2027-08-30

View on ClinicalTrials.gov More HIV trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18 to 55 years.
. Can visit a participating clinic and is willing to stay in the study for its full duration.
. Understands the study and is able and willing to give informed consent.
. Agrees not to join another experimental study until the final required clinic visit.
. In good overall health based on medical history, physical exam, and screening lab tests.
. Willing to receive HIV test results.
. Willing to discuss personal risk of getting HIV and to have HIV prevention counseling.

What they're measuring

Part A: Number of participants with solicited local Adverse Events (AEs)

Timeframe: Baseline through Week 48

Part B: Number of participants with solicited local Adverse Events (AEs)

Timeframe: Baseline through Week 24

Part A: Percentage of participants with solicited local Adverse Events (AEs)

Timeframe: Baseline through Week 48

Part B: Percentage of participants with solicited local Adverse Events (AEs)

Timeframe: Baseline through Week 24

Part A: Number of participants with solicited systemic AEs

Timeframe: Baseline through Week 48

Part B: Number of participants with solicited systemic AEs

Timeframe: Baseline through Week 24

Part A: Percentage of participants with solicited systemic AEs

Timeframe: Baseline through Week 48

A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria