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HIVPhase 1NCT07390955

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

A Phase 1 study testing ePGT121v1-LS (IV), PGDM1400LS (IV) and VRC07-523LS (IV) in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
ePGT121v1-LS (IV), PGDM1400LS (IV) and VRC07-523LS (IV)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
11 sitesin 3 countries
Study dates
19 Mar 2026to 30 Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
Show all 23Show fewer
  • Willing to discuss personal risk of getting HIV and to have HIV prevention counseling.
  • Judged by clinic staff to have a low risk of getting HIV and agrees to avoid higher risk behaviors through the last clinic visit.
  • Hemoglobin levels:
  • Women: at least 11.0 g/dL
  • Men: at least 13.0 g/dL
  • White blood cell count between 2,500 and 12,000 cells/mm³.
  • White blood cell differential is normal or acceptable to clinic staff.
  • Platelet count between 125,000 and 550,000 cells/mm³.
  • ALT (liver enzyme) less than 1.25 times the lab's upper limit of normal.
  • Creatinine (kidney test) less than 1.1 times the lab's upper limit of normal.
  • Negative tests for HIV 1 and HIV 2.
  • Negative hepatitis B surface antigen.
  • Negative hepatitis C antibody, or a negative HCV PCR if the antibody test is positive.
  • Urine protein is negative or only trace.
  • 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.
  • 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.
  • 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.

Who cannot join

  • Received blood products within 120 days before the first study dose (unless the safety review team approves earlier enrollment).
  • Took any experimental (investigational) research drug within 30 days before the first study dose.
  • Weighs less than 35 kg or more than 115 kg.
  • Plans to join another study using an experimental product, or any study that requires non Network HIV antibody testing, during this study.
  • Pregnant or breastfeeding.
  • 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.
Show all 33Show fewer
  • 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.
  • Received humanized or human monoclonal antibodies (mAbs), whether approved or experimental.
  • Previously received monoclonal antibodies that target HIV.
  • Receiving allergy shots within 30 days before the first study dose or scheduled within 14 days after the first dose.
  • 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.
  • History of serious reactions to components of the study products, including anaphylaxis or symptoms like hives, trouble breathing, swelling (angioedema), or abdominal pain.
  • Received immunoglobulin within 60 days before the first study dose (separate from mAbs listed above).
  • 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.
  • Immunodeficiency.
  • 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.
  • 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.
  • A psychiatric condition that prevents following the study. Specifically excluded: psychosis, current suicide risk, or a suicide attempt within the past 3 years.
  • Currently on tuberculosis treatment.
  • Asthma that is more than mild and well controlled.
  • Diabetes (type 1 or type 2). Not excluded: type 2 controlled with diet only, or a past history of gestational diabetes.
  • High blood pressure (hypertension).
  • Diagnosed bleeding disorder.
  • Cancer. Not excluded: surgically removed cancers with good assurance of cure or very low risk of recurrence during the study period.
  • 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.
  • Asplenia (no functioning spleen).
  • 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.

Trial locations and contacts

11 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

11 sites in 3 countries

United States7 sites, 7 recruiting

  • The Ponce de Leon Center CRS (Site ID: 5802)

    Atlanta, Georgia, 30308

    Ericka Patrick, 1-404-616-6313, erpatri@emory.edu

    Not yet recruiting

  • Alabama CRS (Site ID: 31788)

    Birmingham, Alabama, 35222

    Heather Logan, 205-873-8686, heatherlogan@uabmc.edu

    Recruiting

  • Brigham and Women's Hospital Vaccine CRS (BWH VCRS) (Site ID: 30007)

    Boston, Massachusetts, 02115

    Jose H Licona, 1-617-525-9433, jlicona@partners.org

    Not yet recruiting

  • Houston Advancing Research Team CRS (Site ID: 31473)

    Houston, Texas, 77030

    Maria L. Martinez, 1-713-500-6718, Maria.L.Martinez@uth.tmc.edu

    Recruiting

  • Vanderbilt Vaccine (VV) CRS (Site ID: 30352)

    Nashville, Tennessee, 37232

    Shonda E Sumner, 615-343-6906, Shonda.sumner@vumc.org

    Recruiting

  • Penn Prevention CRS (Site ID: 30310)

    Philadelphia, Pennsylvania, 19104

    Debora Dunbar, 1-215-746-3713, ddunbar@pennmedicine.upenn.edu

    Recruiting

  • Bridge HIV CRS (Site ID: 30305)

    San Francisco, California, 94102

    Emily Schaeffer, 1-415-214-1085, emily.schaeffer@sfdph.org

    Recruiting

Other trials in United States

Peru2 sites, 2 recruiting

  • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site ID: 31970)

    Bellavista, Provincia Constitucional del Callao, 07006

    Fanny G Rosas Benancio, 51-1-4800401 ext. 1007, frosas@citbm.pe

    Not yet recruiting

  • Via Libre CRS (Site ID: 31909)

    Lima Cercado, Lima region, 15001

    Carlos Anton Talledo, 51-12-039900 ext. 156, canton@vialibre.org.pe

    Not yet recruiting

Other trials in Peru

Zimbabwe2 sites, 2 recruiting

  • Seke South CRS (Site ID: 30294)

    Harare

    Thandiwe Chirenda, RGN, MPH, 263-77-2460038, tchirenda@uz-ctrc.org

    Not yet recruiting

  • Spilhaus CRS (Site ID: 30314)

    Harare

    Muchaneta Bhondai-Mhuri, 263-772859799, mbhondai@uz-ctrc.org

    Not yet recruiting

Other trials in Zimbabwe

About this study

Official title: 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

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).

Read more

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.

Conditions
HIV
Being tested
ePGT121v1-LS (IV), PGDM1400LS (IV), VRC07-523LS (IV), ePGT121v1-LS (SC), PGDM1400LS (SC)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ePGT121v1-LS (IV)Biological

    Intravenous infusion (IV)

  • PGDM1400LS (IV)Biological

    IV infusion

  • VRC07-523LS (IV)Biological

    IV infusion

  • ePGT121v1-LS (SC)Biological

    Subcutaneous (SC) injection

  • PGDM1400LS (SC)Biological

    SC injection

  • VRC07-523LS (SC)Biological

    SC injection

Study groups in NCT07390955
Study groupRoleWhat they receive
Part A: Group 1ExperimentalePGT121v1-LS 5 mg/kg to be administered via intravenous (IV) infusion at Week 0 and Week 24
Receives: Biological: ePGT121v1-LS (IV)
Part A: Group 2ExperimentalePGT121v1-LS 20 mg/kg to be administered via IV infusion at Week 0 and Week 24
Receives: Biological: ePGT121v1-LS (IV)
Part A: Group 3ExperimentalePGT121v1-LS 40 mg/kg to be administered via IV infusion at Week 0 and Week 24
Receives: Biological: ePGT121v1-LS (IV)
Part A: Group 4ExperimentalePGT121v1-LS 5 mg/kg + PGDM1400LS 5 mg/kg + VRC07-523LS 5 mg/kg to be administered via IV infusion sequentially in this order at Week 0 and Week 24
Receives: Biological: ePGT121v1-LS (IV); Biological: PGDM1400LS (IV); Biological: VRC07-523LS (IV)
Part A: Group 5ExperimentalePGT121v1-LS 20 mg/kg + PGDM1400LS 20 mg/kg + VRC07-523LS 20 mg/kg to be administered via IV infusion sequentially in this order at Week 0 and Week 24
Receives: Biological: ePGT121v1-LS (IV); Biological: PGDM1400LS (IV); Biological: VRC07-523LS (IV)
Part A: Group 6ExperimentalePGT121v1-LS 40 mg/kg + PGDM1400LS 40 mg/kg + VRC07-523LS 40 mg/kg to be administered via IV infusion sequentially in this order at Week 0 and Week 24
Receives: Biological: ePGT121v1-LS (IV); Biological: PGDM1400LS (IV); Biological: VRC07-523LS (IV)
Part B: Group 7ExperimentalePGT121v1-LS 375 mg (3 injections of 125 mg each) to be administered via subcutaneous (SC) injection at Week 0 and Week 12
Receives: Biological: ePGT121v1-LS (SC)
Part B: Group 8ExperimentalePGT121v1-LS 125 mg + PGDM1400LS 100 mg + VRC07-523LS 100 mg to be administered via SC injection sequentially in this order at Week 0 and Week 12
Receives: Biological: ePGT121v1-LS (SC); Biological: PGDM1400LS (SC); Biological: VRC07-523LS (SC)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline through Week 48

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

    Measured: Baseline through Week 24

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

    Measured: Baseline through Week 48

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

    Measured: Baseline through Week 24

  5. Part A: Number of participants with solicited systemic AEs

    Measured: Baseline through Week 48

  6. Part B: Number of participants with solicited systemic AEs

    Measured: Baseline through Week 24

  7. Part A: Percentage of participants with solicited systemic AEs

    Measured: Baseline through Week 48

  8. Part B: Percentage of participants with solicited systemic AEs

    Measured: Baseline through Week 24

  9. Part A: Percentage of participants with safety laboratory abnormalities meeting grade 1 AE criteria or above

    Measured: Baseline through Week 48

  10. Part B: Percentage of participants with safety laboratory abnormalities meeting grade 1 AE criteria or above

    Measured: Baseline through Week 24

  11. Part A: Number of participants with unsolicited AEs

    Measured: Baseline through Week 48

  12. Part B: Number of participants with unsolicited AEs

    Measured: Baseline through Week 24

  13. Part A: Percentage of participants with unsolicited AEs

    Measured: Baseline through Week 48

  14. Part B: Percentage of participants with unsolicited AEs

    Measured: Baseline through Week 24

  15. Part A: Number of participants with Serious Adverse Events (SAEs)

    Measured: Baseline through Week 48

  16. Part B: Number of participants with Serious Adverse Events (SAEs)

    Measured: Baseline through Week 24

  17. Part A: Percentage of participants with Serious Adverse Events (SAEs)

    Measured: Baseline through Week 48

  18. Part B: Percentage of participants with Serious Adverse Events (SAEs)

    Measured: Baseline through Week 24

  19. Part A: Number of participants who discontinue study product administration

    Measured: Baseline through Week 48

  20. Part B: Number of participants who discontinue study product administration

    Measured: Baseline through Week 24

  21. Part A: Percentage of participants who discontinue study product administration

    Measured: Baseline through Week 48

  22. Part B: Percentage of participants who discontinue study product administration

    Measured: Baseline through Week 24

  23. Part A: Number of participants who terminate the study early

    Measured: Baseline through Week 48

  24. Part B: Number of participants who terminate the study early

    Measured: Baseline through Week 24

  25. Part A: Percentage of participants who terminate the study early

    Measured: Baseline through Week 48

  26. Part B: Percentage of participants who terminate the study early

    Measured: Baseline through Week 24

  27. Part A: Serum Concentration of ePGT121v1-LS

    Measured by anti-idiotype binding antibody multiplex assay

    Measured: Baseline through Week 48

  28. Part B: Serum Concentration of ePGT121v1-LS

    Measured by anti-idiotype binding antibody multiplex assay

    Measured: Baseline through Week 24

  29. Part A: Serum Concentration of PGDM1400LS

    Measured by anti-idiotype binding antibody multiplex assay

    Measured: Baseline through Week 48

  30. Part B: Serum Concentration of PGDM1400LS

    Measured by anti-idiotype binding antibody multiplex assay

    Measured: Baseline through Week 24

  31. Part A: Serum Concentration of VRC07-523LS

    Measured by anti-idiotype binding antibody multiplex assay

    Measured: Baseline through Week 48

  32. Part B: Serum Concentration of VRC07-523LS

    Measured by anti-idiotype binding antibody multiplex assay

    Measured: Baseline through Week 24

  33. Part A: Area Under the Concentration-Time Curve (AUC) of ePGT121v1-LS

    Measured: Baseline through Week 48

  34. Part B: AUC of ePGT121v1-LS

    Measured: Baseline through Week 24

  35. Part A: AUC of PGDM1400LS

    Measured: Baseline through Week 48

  36. Part B: AUC of PGDM1400LS

    Measured: Baseline through Week 24

  37. Part A: AUC of VRC07-523LS

    Measured: Baseline through Week 48

  38. Part B: AUC of VRC07-523LS

    Measured: Baseline through Week 24

  39. Part A: Maximum Observed Concentration (Cmax) of ePGT121v1-LS

    Measured: Baseline through Week 48

  40. Part B: Cmax of ePGT121v1-LS

    Measured: Baseline through Week 24

  41. Part A: Cmax of PGDM1400LS

    Measured: Baseline through Week 48

  42. Part B: Cmax of PGDM1400LS

    Measured: Baseline through Week 24

  43. Part A: Cmax of VRC07-523LS

    Measured: Baseline through Week 48

  44. Part B: Cmax of VRC07-523LS

    Measured: Baseline through Week 24

  45. Part A: Time to Maximum Concentration (Tmax) of ePGT121v1-LS

    Measured: Baseline through Week 48

  46. Part B: Tmax of ePGT121v1-LS

    Measured: Baseline through Week 24

  47. Part A: Tmax of PGDM1400LS

    Measured: Baseline through Week 48

  48. Part B: Tmax of PGDM1400LS

    Measured: Baseline through Week 24

  49. Part A: Tmax of VRC07-523LS

    Measured: Baseline through Week 48

  50. Part B: Tmax of VRC07-523LS

    Measured: Baseline through Week 24

  51. Part A: Clearance (CL) of ePGT121v1-LS

    Measured: Baseline through Week 48

  52. Part B: CL of ePGT121v1-LS

    Measured: Baseline through Week 24

  53. Part A: CL of PGDM1400LS

    Measured: Baseline through Week 48

  54. Part B: CL of PGDM1400LS

    Measured: Baseline through Week 24

  55. Part A: CL of VRC07-523LS

    Measured: Baseline through Week 48

  56. Part B: CL of VRC07-523LS

    Measured: Baseline through Week 24

  57. Part A: Volume of Distribution (Vd) of ePGT121v1-LS

    Measured: Baseline through Week 48

  58. Part B: Vd of ePGT121v1-LS

    Measured: Baseline through Week 24

  59. Part A: Vd of PGDM1400LS

    Measured: Baseline through Week 48

  60. Part B: Vd of PGDM1400LS

    Measured: Baseline through Week 24

  61. Part A: Vd of VRC07-523LS

    Measured: Baseline through Week 48

  62. Part B: Vd of VRC07-523LS

    Measured: Baseline through Week 24

  63. Part A: Terminal Elimination Rate Constant (λz) of ePGT121v1-LS

    Measured: Baseline through Week 48

  64. Part B: λz of ePGT121v1-LS

    Measured: Baseline through Week 24

  65. Part A: λz of PGDM1400LS

    Measured: Baseline through Week 48

  66. Part B: λz of PGDM1400LS

    Measured: Baseline through Week 24

  67. Part A: λz of VRC07-523LS

    Measured: Baseline through Week 48

  68. Part B: λz of VRC07-523LS

    Measured: Baseline through Week 24

  69. Part A: Terminal Half-life (T1/2) of ePGT121v1-LS

    Measured: Baseline through Week 48

  70. Part B: T1/2 of ePGT121v1-LS

    Measured: Baseline through Week 24

  71. Part A: T1/2 of PGDM1400LS

    Measured: Baseline through Week 48

  72. Part B: T1/2 of PGDM1400LS

    Measured: Baseline through Week 24

  73. Part A: T1/2 of VRC07-523LS

    Measured: Baseline through Week 48

  74. Part B: T1/2 of VRC07-523LS

    Measured: Baseline through Week 24

  75. Part A: Area Under the Magnitude-Breadth Curve (AUC-MB)

    The AUC-MB to a global panel of pseudoviruses (78) will be computed for each evaluable participant

    Measured: Baseline through Week 48

  76. Part B: AUC-MB

    The AUC-MB to a global panel of pseudoviruses (78) will be computed for each evaluable participant

    Measured: Baseline through Week 24

Secondary outcomes (8)

  1. Serum Concentration of ePGT121v1-LS

    Measured by anti-idiotype binding antibody multiplex assay for all participants in all groups regardless of how many product administrations and how much product they received

    Measured: Baseline through Week 48

  2. Serum Concentration of PGDM1400LS

    Measured by anti-idiotype binding antibody multiplex assay for all participants in all groups regardless of how many product administrations and how much product they received

    Measured: Baseline through Week 48

  3. Serum Concentration of VRC07-523LS

    Measured by anti-idiotype binding antibody multiplex assay for all participants in all groups regardless of how many product administrations and how much product they received

    Measured: Baseline through Week 48

  4. Correlation Between Serum/Plasma Concentration and Serum Neutralization Titer (ID50) for Each Virus

    All participants in all groups regardless of how many product administrations and how much product they received

    Measured: Baseline through Week 48

  5. Correlation Between Serum/Plasma Concentration and Serum Neutralization Titer (ID80) for Each Virus

    All participants in all groups regardless of how many product administrations and how much product they received

    Measured: Baseline through Week 48

  6. Correlation Between Serum/Plasma Concentration and AUC-MB of Serum Neutralization Across the Virus Panel

    All participants in all groups regardless of how many product administrations and how much product they received

    Measured: Baseline through Week 48

  7. Area Under the Magnitude-Breadth Curve (AUC-MB)

    All participants in all groups regardless of how many product administrations and how much product they received

    Measured: Baseline through Week 48

  8. Population pharmacokinetic (PopPK) modeling of monoclonal antibody (mAb) concentration-time data

    Measured: Baseline through Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start19 Mar 2026
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
83 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07390955
Sponsor's protocol ID
HVTN 141/HPTN 105
Other IDs
38950
Status last verified
Aug 2026
First submitted
22 Dec 2025
Last updated
1 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ePGT121v1-LS (IV), PGDM1400LS (IV) and VRC07-523LS (IV) in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Peru, Zimbabwe. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Number of participants with solicited local Adverse Events (AEs) (time frame: Baseline through Week 48). The study lists 76 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07390955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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