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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

A Phase 1 Clinical Trial to Evaluate the Safety, Pharmacokinetics, and in Vitro Neutralization of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS Administered in Multiple Doses and Routes to Adult Participants Without HIV-1

A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1 (NCT07390955) is a Phase 1 interventional studying HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For HIV, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 83 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused HIV subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age 18 to 55 years. 2. Can visit a participating clinic and is willing to stay in the study for its full duration. 3. Understands the study and is able and willing to give willing to sign a consent form. 4. Agrees not to join another experimental study until the final required clinic visit. 5. In good overall health based on medical history, physical exam, and screening lab tests. 6. Willing to receive HIV test results. 7. Willing to discuss personal risk of getting HIV and to have HIV prevention counseling. 8. Judged by clinic staff to have a low risk of getting HIV and agrees to avoid higher risk behaviors through the last clinic visit. 9. Hemoglobin levels: - Women: at least 11.0 g/dL - Men: at least 13.0 g/dL 10. White blood cell count between 2,500 and 12,000 cells/mm³. 11. White blood cell differential is normal or acceptable to clinic staff. 12. Platelet count between 125,000 and 550,000 cells/mm³. 13. ALT (liver enzyme) less than 1.25 times the lab's upper limit of normal. 14. Creatinine (kidney test) less than 1.1 times the lab's upper limit of normal. 15. Negative tests for HIV 1 and HIV 2. 16. Negative hepatitis B surface antigen. 17. Negative hepatitis C antibody, or a negative HCV PCR if the antibody test is positive. 18. Urine protein is negative or only trace. 19. If a woman who could become pregnant: negative pregnancy test within 72 hours before the first study treatment. Women with a documented total hysterectomy, both ovaries removed, both fallopian tubes removed, or menopause (no periods for at least 1 year) do not need pregnancy testing. 20. Women who could become pregnant agree to use effective birth control for sex that could lead to pregnancy starting at least 21 days before enrollment and continuing through the last study visit. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age 18 to 55 years. 2. Can visit a participating clinic and is willing to stay in the study for its full duration. 3. Understands the study and is able and willing to give informed consent. 4. Agrees not to join another experimental study until the final required clinic visit. 5. In good overall health based on medical history, physical exam, and screening lab tests. 6. Willing to receive HIV test results. 7. Willing to discuss personal risk of getting HIV and to have HIV prevention counseling. 8. Judged by clinic staff to have a low risk of getting HIV and agrees to avoid higher risk behaviors through the last clinic visit. 9. Hemoglobin levels: * Women: at least 11.0 g/dL * Men: at least 13.0 g/dL 10. White blood cell count between 2,500 and 12,000 cells/mm³. 11. White blood cell differential is normal or acceptable to clinic staff. 12. Platelet count between 125,000 and 550,000 cells/mm³. 13. ALT (liver enzyme) less than 1.25 times the lab's upper limit of normal. 14. Creatinine (kidney test) less than 1.1 times the lab's upper limit of normal. 15. Negative tests for HIV 1 and HIV 2. 16. Negative hepatitis B surface antigen. 17. Negative hepatitis C antibody, or a negative HCV PCR if the antibody test is positive. 18. Urine protein is negative or only trace. 19. If a woman who could become pregnant: negative pregnancy test within 72 hours before the first study treatment. Women with a documented total hysterectomy, both ovaries removed, both fallopian tubes removed, or menopause (no periods for at least 1 year) do not need pregnancy testing. 20. Women who could become pregnant agree to use effective birth control for sex that could lead to pregnancy starting at least 21 days before enrollment and continuing through the last study visit. 21. Women who could become pregnant also agree not to try to become pregnant using methods like egg retrieval, artificial insemination, or in vitro fertilization starting at least 21 days before enrollment and continuing through the last clinic visit. Exclusion Criteria: 1. Received blood products within 120 days before the first study dose (unless the safety review team approves earlier enrollment). 2. Took any experimental (investigational) research drug within 30 days before the first study dose. 3. Weighs less than 35 kg or more than 115 kg. 4. Plans to join another study using an experimental product, or any study that requires non Network HIV antibody testing, during this study. 5. Pregnant or breastfeeding. 6. Previously received an HIV vaccine in a vaccine trial. If a potential participant received placebo/control only, eligibility will be decided case by case by the safety review team. 7. Received any non HIV vaccine within 14 days before enrollment or plan to get one within 14 days after enrollment. Exception: ACAM2000 smallpox vaccine within 28 days before enrollment (or scab still present if earlier) or planned within 14 days after enrollment. 8. Received humanized or human monoclonal antibodies (mAbs), whether approved or experimental. 9. Previously received monoclonal antibodies that target HIV. 10. Receiving allergy shots within 30 days before the first study dose or scheduled within 14 days after the first dose. 11. Took immune suppressing medicines within 30 days before the first study dose. Not excluded: nasal steroid sprays; inhaled steroids (see asthma item); topical steroids for mild skin conditions; or one short course of oral/IV prednisone (less than 20 mg/day for under 14 days) finished at least 7 days before the first infusion/injection. 12. History of serious reactions to components of the study products, including anaphylaxis or symptoms like hives, trouble breathing, swelling (angioedema), or abdominal pain. 13. Received immunoglobulin within 60 days before the first study dose (separate from mAbs listed above). 14. Autoimmune disease that is not mild, stable, and uncomplicated. Mild, stable cases not needing immune suppressing drugs may be allowed if the investigator judges low risk. 15. Immunodeficiency. 16. Any significant medical issue, abnormal exam or lab result, or past condition that could: * Affect the immune system or its response, * Require medicines that affect the immune system, * Make repeated injections, infusions, or blood draws unsafe or not feasible (for example, very difficult veins), * Need active medical care to prevent serious harm during the study, * Have symptoms that could be mistaken for reactions to the study product, * Or is otherwise listed among these exclusions. 17. Any medical or skin condition, social situation, or job duty that, in the investigator's judgment, would interfere with following the study, safety assessments, or giving informed consent. 18. A psychiatric condition that prevents following the study. Specifically excluded: psychosis, current suicide risk, or a suicide attempt within the past 3 years. 19. Currently on tuberculosis treatment. 20. Asthma that is more than mild and well controlled. 21. Diabetes (type 1 or type 2). Not excluded: type 2 controlled with diet only, or a past history of gestational diabetes. 22. High blood pressure (hypertension). 23. Diagnosed bleeding disorder. 24. Cancer. Not excluded: surgically removed cancers with good assurance of cure or very low risk of recurrence during the study period. 25. Seizure disorder with any seizure in the past 3 years, or use of seizure prevention or seizure treatment medicines at any time in the past 3 years. 26. Asplenia (no functioning spleen). 27. History of widespread hives, swelling (angioedema), or anaphylaxis. Not excluded if due to a known trigger and there have been no reactions for at least 5 years, showing successful avoidance of the trigger.

Treatments Being Tested

BIOLOGICAL

ePGT121v1-LS (IV)

Intravenous infusion (IV)

BIOLOGICAL

PGDM1400LS (IV)

IV infusion

BIOLOGICAL

VRC07-523LS (IV)

IV infusion

BIOLOGICAL

ePGT121v1-LS (SC)

Subcutaneous (SC) injection

BIOLOGICAL

PGDM1400LS (SC)

SC injection

BIOLOGICAL

VRC07-523LS (SC)

SC injection

Locations (10)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Alabama CRS (Site ID: 31788)
Birmingham, Alabama, United States
Bridge HIV CRS (Site ID: 30305)
San Francisco, California, United States
George Washington University CRS (Site ID: 31608)
Washington D.C., District of Columbia, United States
The Ponce de Leon Center CRS (Site ID: 5802)
Atlanta, Georgia, United States
Brigham and Women's Hospital Vaccine CRS (BWH VCRS) (Site ID: 30007)
Boston, Massachusetts, United States
Penn Prevention CRS (Site ID: 30310)
Philadelphia, Pennsylvania, United States
Vanderbilt Vaccine (VV) CRS (Site ID: 30352)
Nashville, Tennessee, United States
Houston Advancing Research Team CRS (Site ID: 31473)
Houston, Texas, United States
Via Libre CRS (Site ID: 31909)
Lima Cercado, Lima region, Peru
Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970)
Bellavista, Provincia Constitucional del Callao, Peru

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07390955), the sponsor (National Institute of Allergy and Infectious Diseases (NIAID)), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07390955 clinical trial studying?

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, b… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07390955?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07390955?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07390955. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07390955. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.