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Safety and drug levels of three lab-made HIV antibodies in adults without HIV

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

Phase 1 Interventional National Institute of Allergy and Infectious Diseases (NIAID) · NCT07390955

This study will test whether one or combinations of three lab-made HIV antibodies given by IV or under the skin are safe and how long they stay in the body in healthy adults without HIV.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment83 (estimated)
Ages18 Years to 55 Years
SexAll
SponsorNational Institute of Allergy and Infectious Diseases (NIAID) NIH
Drugs / interventionsprednisone
Locations12 sites (Birmingham, Alabama and 11 other locations)
Trial IDNCT07390955 on ClinicalTrials.gov

What this trial studies

Researchers will give the lab-made antibody ePGT121v1-LS alone and together with two other antibodies (PGDM1400LS and VRC07-523LS) by intravenous (IV) infusion or subcutaneous (SC) injection to healthy adults without HIV. About 83 volunteers will be enrolled across two parts, with Part A using multiple dose groups (including IV doses of 5, 20, and 40 mg/kg) and Part B testing additional dosing and routes. The study will monitor safety and side effects, measure drug levels over time (pharmacokinetics), and test how well participants' serum neutralizes HIV. Investigators will also look for any interactions between antibodies when they are given together.

Who should consider this trial

Good fit: Healthy adults aged 18–55 who do not have HIV, are judged to be at low risk for acquiring HIV, and can attend all required clinic visits and testing are ideal candidates.

Not a fit: People living with HIV, those outside the 18–55 age range, or individuals unable to avoid higher-risk behaviors or attend required visits are unlikely to receive benefit from this study.

Why it matters

Potential benefit: If successful, the study could identify safe dosing and antibody combinations that inform future HIV prevention approaches.

How similar studies have performed: Other broadly neutralizing HIV antibodies have been tested in humans and shown acceptable safety and antiviral activity, but combination regimens and prevention efficacy are still being studied.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 11 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions HIV
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.