A Phase 1 interventional study of 3BNC117-LS and Placebo in Human Immunodeficiency Virus, sponsored by Rockefeller University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Rockefeller University · Phase 1, Interventional, and Prevention
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
The proposed study is a phase 1 study of the mAb 3BNC117-LS administered intravenously in HIV uninfected individuals and HIV-infected individuals, and subcutaneously in HIV-uninfected individuals.The objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of a single administration of 3BNC117-LS.
The proposed study is a Phase 1, open label, dose escalation cohort study of 3BNC117-LS administered intravenously in HIV-uninfected and HIV-1 infected participants.
This study consists of two parts. In part A, study participants will be enrolled in an open label manner to receive a single intravenous infusion of 3BNC117-LS at one of three increasing dose levels (3 mg/kg, 10 mg/kg and 30 mg/kg). Participants in Part B will also receive a single administration of 3BNC117-LS, however, the product administered in Part B of the study derives from a new manufacturing lot. The manufacturing lot used in Part A had incomplete glycosylation of the 3BNC117-LS light chain, which has been corrected in the new lot. Participants in Part B will receive 3BNC117-LS intravenously at 30 mg/kg in an open label manner (HIV-uninfected and HIV-infected) or will be randomized to receive a subcutaneous injection of 3BNC117-LS or placebo in a double-blinded fashion (HIV-uninfected only).
Part A has already been enrolled with 21 participants. Part B has a planned enrollment of 22 participants.
Part A
Part B
Following 3BNC117-LS infusion, study participants will return for safety assessments at weeks 1, 2 and 4 following infusion, then bi-monthly or monthly until the end of study follow up.
Serum samples for PK (pharmacokinetic) measurements will be collected before 3BNC117-LS infusion, at the end of the infusion, and at multiple time points during study follow up.
Samples will also be collected for measurement of HIV-1 plasma RNA levels before 3BNC117-LS infusion (screen, pre-infusion and day 0) and at all follow up visits in Groups 2B and 2C.
All participants will be followed for 48 weeks after 3BNC117-LS administration.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
This study's enrollment of 43 is below the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Rockefeller University is the lead sponsor of 123 studies on the registry; 3 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Groups 1A-1F (-uninfected):
If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use two effective methods of (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting IUD, hormone-based contraceptive with condom) from 10 days prior to and until seven months after 3BNC117-LS infusion, and agrees to safer sex counseling at each visit.
Groups 2B-2D (HIV-infected):
Exclusion Criteria:
Groups 1A-1F (-uninfected):
Laboratory abnormalities in the parameters listed:
Groups 2B-2D (HIV-infected):
Laboratory abnormalities in the parameters listed below:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 3 mg/kg.
Drug: 3BNC117-LS
HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 10 mg/kg.
Drug: 3BNC117-LS
HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
Drug: 3BNC117-LS
HIV-infected individuals on ART with HIV-1 plasma RNA levels \< 20 copies/ml or off ART for at least 8 weeks with HIV-1 plasma RNA levels \< 100,000 copies/ml, will be administered one infusion of 3BNC117-LS dosed at 10 mg/kg.
Drug: 3BNC117-LS
HIV-infected individuals on ART with HIV-1 plasma RNA levels \< 20 copies/ml, or off ART for at least 8 weeks with HIV-1 plasma RNA levels \< 100,000 copies/ml, will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
Drug: 3BNC117-LS
HIV-uninfected individuals will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
Drug: 3BNC117-LS
HIV-infected individuals on ART with HIV-1 plasma RNA levels \< 20 copies/ml will be administered one infusion of 3BNC117-LS dosed at 30 mg/kg.
Drug: 3BNC117-LS
HIV-uninfected individuals will be administered a single 1 mL (approximately 150 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.
Drug: 3BNC117-LS · Drug: Placebo
HIV-uninfected individuals will be administered a single 2 mL (approximately 300 mg) subcutaneous injection of 3BNC117-LS or placebo in a 3:1 ratio.
Drug: 3BNC117-LS · Drug: Placebo
Intravenous infusion of 3BNC117-LS
Also known as: Monoclonal Antibody
Placebo
The Number of Participants Who Experience Adverse Events Within 2 Weeks After 3BNC117-LS Infusion in All Study Groups
Adverse events include signs, symptoms and laboratory abnormalities, in addition to local and systemic reactogenicity adverse events.
Time frame: 2 weeks following the 3BNC117-LS infusion
Elimination Half-life (t1/2) of 3BNC117-LS in All Study Groups
Elimination half-life (t1/2) measured in days of 3BNC117-LS in all study groups
Time frame: 48 weeks
Frequency of Induced Anti-3BNC117-LS Antibodies in All Study Groups.
number of participants with induced Anti-3BNC117-LS antibodies in all study groups
Time frame: 48 weeks
The Number of Participants Who Experience Adverse Events During Study Follow-up
Adverse events include signs, symptoms and laboratory abnormalities
Time frame: 48 weeks
| Milestone | Group 1A | Group 1B | Group 1C | Group 2B | Group 2C | Group 1D | Group 2D | Group 1E 3BNC117-LS | Group 1F 3BNC117-LS | Group 1E Placebo | Group 1F Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 3 | 3 | 6 | 3 | 6 | 3 | 3 | 6 | 6 | 2 | 2 |
| Completed | 3 | 3 | 5 | 3 | 6 | 2 | 3 | 6 | 6 | 2 | 0 |
| Not completed | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 2 |
Adverse events include signs, symptoms and laboratory abnormalities, in addition to local and systemic reactogenicity adverse events.
| Participants | Group 1A | Group 1B | Group 1C | Group 2B | Group 2C | Group 1D | Group 2D | Group 1E 3BNC117-LS | Groups 1F 3BNC117-LS | Group 1E Placebo | Group 1F Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|
| The Number of Participants Who Experience Adverse Events Within 2 Weeks After 3BNC117-LS Infusion in All Study Groups | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 0 |
Elimination half-life (t1/2) measured in days of 3BNC117-LS in all study groups
| Days (median half-life per group) | Group 1A | Group 1B | Group 1C | Group 2B | Group 2C | Group 1D | Group 2D | Group 1E- 3BNC117-LS | Group 1F - 3BNC117-LS |
|---|---|---|---|---|---|---|---|---|---|
| Elimination Half-life (t1/2) of 3BNC117-LS in All Study Groups | 76.33 (69.31 to 107.30) | 58.81 (51.48 to 59.00) | 61.98 (41.49 to 83.51) | 60.83 (54.10 to 98.85) | 45.45 (41.85 to 62.64) | 59.04 (57.60 to 64.41) | 52.44 (39.49 to 64.52) | 63.60 (53.82 to 76.65) | 67.59 (49.69 to 78.26) |
number of participants with induced Anti-3BNC117-LS antibodies in all study groups
| Participants | Group 1A | Group 1B | Group 1C | Group 2B | Group 2C | Group 1D | Group 2D | Group 1E - 3BNC117-LS | Group 1F - 3BNC117-LS |
|---|---|---|---|---|---|---|---|---|---|
| Frequency of Induced Anti-3BNC117-LS Antibodies in All Study Groups. | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 |
Adverse events include signs, symptoms and laboratory abnormalities
| Participants | Groups 1A | Group 1B | Group 1C | Group 2B | Group 2C | Group 1D | Group 2D | Group 1E - 3BNC117-LS | Group 1F - 3BNC117-LS | Group 1E -Placebo | Group 1F - Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|
| The Number of Participants Who Experience Adverse Events During Study Follow-up | 3 | 2 | 4 | 1 | 3 | 0 | 0 | 1 | 0 | 1 | 1 |
Collected over 48 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1A | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Group 1B | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Group 1C | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Group 2B | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| Group 2C | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Group 1D | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Group 2D | 0/3 (0%) | 1/3 (33.3%) | 1/3 (33.3%) |
| Group 1E 3BNC117-LS | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| Group 1F 3BNC117-LS | 0/6 (0%) | 1/6 (16.7%) | 4/6 (66.7%) |
| Group 1E Placebo | 0/2 (0%) | 0/2 (0%) | 2/2 (100%) |
| Group 1F Placebo | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Event | Group 1A | Group 1B | Group 1C | Group 2B | Group 2C | Group 1D | Group 2D | Group 1E 3BNC117-LS | Group 1F 3BNC117-LS | Group 1E Placebo | Group 1F Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|
| CellulitisInfections and infestations | 0/3 | 0/3 | 0/6 | 0/3 | 0/6 | 0/3 | 1/3 | 0/6 | 0/6 | 0/2 | 0/2 |
| Transient ischemic attackNervous system disorders | 0/3 | 0/3 | 0/6 | 0/3 | 0/6 | 0/3 | 0/3 | 0/6 | 1/6 | 0/2 | 0/2 |
| Event | Group 1A | Group 1B | Group 1C | Group 2B | Group 2C | Group 1D | Group 2D | Group 1E 3BNC117-LS | Group 1F 3BNC117-LS | Group 1E Placebo | Group 1F Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Upper Respiratory InfectionInfections and infestations | 2/3 | 0/3 | 0/6 | 0/3 | 0/6 | 1/3 | 0/3 | 1/6 | 1/6 | 0/2 | 0/2 |
| NauseaGastrointestinal disorders | 0/3 | 0/3 | 0/6 | 0/3 | 1/6 | 0/3 | 0/3 | 0/6 | 1/6 | 1/2 | 0/2 |
| Conjunctivitis allergicEye disorders | 0/3 | 0/3 | 0/6 | 0/3 | 0/6 | 0/3 | 0/3 | 0/6 | 0/6 | 0/2 | 1/2 |
| Glucose tolerance impairedInvestigations | 0/3 | 0/3 | 0/6 | 0/3 | 0/6 | 0/3 | 0/3 | 0/6 | 0/6 | 1/2 | 0/2 |
| Alcohol abusePsychiatric disorders | 0/3 | 0/3 | 0/6 | 0/3 | 0/6 | 0/3 | 0/3 | 0/6 | 0/6 | 1/2 | 0/2 |
| DizzinessGeneral disorders | 0/3 | 1/3 | 0/6 | 0/3 | 0/6 | 0/3 | 0/3 | 0/6 | 1/6 | 0/2 | 0/2 |
| Decreased hemoglobinBlood and lymphatic system disorders | 0/3 | 0/3 | 1/6 | 0/3 | 0/6 | 0/3 | 1/3 | 0/6 | 0/6 | 0/2 | 0/2 |
| Elevated blood pressureCardiac disorders | 0/3 | 0/3 | 0/6 | 1/3 | 1/6 | 0/3 | 0/3 | 0/6 | 1/6 | 0/2 | 0/2 |
| Eye pruritusEye disorders | 0/3 | 0/3 | 0/6 | 0/3 | 0/6 | 1/3 | 0/3 | 0/6 | 0/6 | 0/2 | 0/2 |
| HyperbilirubinaemiaHepatobiliary disorders | 1/3 | 0/3 | 0/6 | 0/3 | 0/6 | 0/3 | 0/3 | 0/6 | 0/6 | 0/2 | 0/2 |
| Age, Categorical(Participants) | Group 1A | Group 1B | Group 1C | Group 2B | Group 2C | Group 1D | Group 2D | Group 1E 3BNC117-LS | Group 1F 3BNC117-LS | Group 1E Placebo | Group 1F Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 6 | 3 | 6 | 3 | 3 | 6 | 6 | 2 | 2 | 43 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Group 1A | Group 1B | Group 1C | Group 2B | Group 2C | Group 1D | Group 2D | Group 1E 3BNC117-LS | Group 1F 3BNC117-LS | Group 1E Placebo | Group 1F Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 31 (24 to 42) | 42 (34 to 56) | 39 (24 to 54) | 48 (26 to 61) | 49 (26 to 63) | 37 (23 to 51) | 50 (33 to 59) | 46 (24 to 64) | 44 (31 to 64) | 54 (52 to 57) | 47 (43 to 52) | 49 (23 to 64) |
| Sex: Female, Male(Participants) | Group 1A | Group 1B | Group 1C | Group 2B | Group 2C | Group 1D | Group 2D | Group 1E 3BNC117-LS | Group 1F 3BNC117-LS | Group 1E Placebo | Group 1F Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 0 | 1 | 4 | 0 | 1 | 2 | 1 | 3 | 5 | 2 | 1 | 20 |
| Male | 3 | 2 | 2 | 3 | 5 | 1 | 2 | 3 | 1 | 0 | 1 | 23 |
| Race (NIH/OMB)(Participants) | Group 1A | Group 1B | Group 1C | Group 2B | Group 2C | Group 1D | Group 2D | Group 1E 3BNC117-LS | Group 1F 3BNC117-LS | Group 1E Placebo | Group 1F Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Asian | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 | 2 | 4 | 3 | 3 | 4 | 3 | 1 | 1 | 27 |
| White | 0 | 0 | 3 | 1 | 2 | 0 | 0 | 2 | 1 | 0 | 1 | 10 |
| More than one race | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Region of Enrollment(Participants) | Group 1A | Group 1B | Group 1C | Group 2B | Group 2C | Group 1D | Group 2D | Group 1E 3BNC117-LS | Group 1F 3BNC117-LS | Group 1E Placebo | Group 1F Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States | 3 | 3 | 6 | 3 | 6 | 3 | 3 | 6 | 6 | 2 | 2 | 43 |
Plan to share: No
Ran from Sep 2017 to primary completion in Dec 2020, 39 months.
Results were first posted in May 2026, 5 years 4 months after primary completion.
Of 63 non-industry phase 1 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 39. This study's 39 months is above that.
Counting every sponsor, half of 139 studies reached it within 14 months; a quarter within 4 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Teropavimab
Acquired Immunodeficiency Syndrome →