A Phase 1 interventional study of VRC-HIVMAB091-00-AB and rHuPH20 in HIV Antibodies, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-01.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment
Background:
The experimental product in this study, N6LS, is a human monoclonal antibody. Antibodies are one way that the human body fights infection. Monoclonal means that all the antibodies in the product are the same. N6LS is directed against the HIV virus. There is no HIV in the N6LS study product and you cannot get HIV from this product. This study is the first time N6LS is tested in humans. It was given into a vein in the arm (intravenously, IV) or as an injection underneath the skin (subcutaneously, SC). The study also tested N6LS mixed with an enzyme, rHuPH20 (recombinant human hyaluronidase). rHuPH20 increases the spread of fluids injected underneath your skin (subcutaneously, SC) and allows for the rapid delivery of large volume injections that can be given with a single needle. It was given as a SC infusion using a small needle attached to an infusion pump. Study products were only given to healthy adults who are not infected with HIV.
Objective:
The main purpose of the study is to see if N6LS alone and N6LS mixed with rHuPH20 is safe in healthy adults. Another goal is to learn how amounts of N6LS in the body change over time.
Study Plan:
Assigned study groups depended on the dose of product, the numbers of times the product was given (once or three times at 12-week intervals), and how the product was given (IV or SC). Blood samples for research were collected at most of the visits. There were about 14 clinic visits over 6 months for all groups who got one dose of product, and about 26 clinic visits over 12 months for the groups who got three doses of product.
Study Design:
This is the first study in healthy adults of the N6LS monoclonal antibody (MAb). It was a dose-escalation study to examine safety, tolerability, dose, and pharmacokinetics (PK) of N6LS administered intravenously (IV) and subcutaneously (SC) to healthy adults. For SC administration, N6LS was administered alone or co-administered with the permeation enhancer rHuPH20 enzyme. Primary hypotheses are that N6LS administration to healthy adults will be safe by the IV and SC routes, alone and with rHuPH20 co-administration. A secondary hypothesis is that all N6LS administrations will be detectable in human sera with a definable half-life
Product Description:
N6LS (VRC-HIVMAB091-00-AB) is a human MAb targeted to the HIV-1 CD4 binding site. It was developed by the VRC/NIAID/NIH and manufactured under current Good Manufacturing Practice (cGMP) regulations at the VRC Vaccine Pilot Plant operated under contract by the Vaccine Clinical Materials Program (VCMP), Leidos Biomedical Research, Inc., Frederick, MD. The product was provided as a sterile aqueous buffered solution in 10 mL glass vials at a concentration of 100 mg/mL and volume of 6.25 mL.
Each vial of ENHANZE™ Drug Product (EDP) contains 0.5 mL of rHuPH20 formulated at a concentration of 1 mg/mL (approximately 110,000 U/mL rHuPH20). rHuPH20 is a tissue permeability modifier that depolymerizes hyaluronan (HA), increasing the dispersion of a substance into the subcutaneous space, which enables SC delivery of co-administered antibody (-ies) at higher dose volumes (e.g., >10 mL) that cannot be administered quickly without rHuPH20. EDP is manufactured by Ajinomoto Althea, Inc. (San Diego, CA) for Halozyme Therapeutics, Inc. (San Diego, CA) and is supplied in 2 mL glass vials as a sterile, single-dose, injectable liquid.
Subjects:
Healthy adults, 18-50 years of age.
Study Plan:
This open-label study included 8 dose groups to assess N6LS alone given as a single IV infusion at the 5, 20, or 40 mg/kg dose level (Groups 1,3 and 4); a single SC injection at the 5 mg/kg dose level (Group 2); or in 3 administrations, spaced 12 weeks apart by SC injection at the 5 mg/kg dose level (Group 5), or by IV infusion at the 20 mg/kg dose level (Group 6). Two additional groups assessed N6LS given as a single SC injection mixed with rHuPH20 (2000 U/mL) at 5 mg/kg (Group 7) or 20 mg/kg (Group 8) doses. Enrollment opened with Groups 1, 2 and 5; and was followed by the sequential activation of Groups 3, 4, and 6. With implementation of the two SC N6LS+rHuPH20 arms as a protocol amendment, Group 7 opened first to accrual, followed by Group 8.
Study Duration:
Study participation was approximately 24 weeks for participants in Groups 1-4, 7 and 8; and 48 weeks for participants in Groups 5 and 6.
National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
A volunteer must have met all of the following criteria:
Screening laboratory criteria within 84 days prior to enrollment meeting the following criteria:
Female-Specific Criteria:
EXCLUSION CRITERIA:
A volunteer would have been excluded if one or more of the following conditions applied:
N6LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0)
Biological: VRC-HIVMAB091-00-AB
N6LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0)
Biological: VRC-HIVMAB091-00-AB
N6LS (20 mg/kg) administered by IV infusion (Day 0)
Biological: VRC-HIVMAB091-00-AB
N6LS (40 mg/kg) administered by IV infusion (Day 0)
Biological: VRC-HIVMAB091-00-AB
N6LS (5 mg/kg) administered by SC injection (Day 0, Week 12 and Week 24)
Biological: VRC-HIVMAB091-00-AB
N6LS (20 mg/kg) administered by IV infusion (Day 0, Week 12 and Week 24)
Biological: VRC-HIVMAB091-00-AB
N6LS (5 mg/kg) + rHuPH20 (2000 U/ml) administered by SC injection (Day 0)
Biological: VRC-HIVMAB091-00-AB · Biological: rHuPH20
N6LS (20 mg/kg) + rHuPH20 (2000 U/ml) administered by SC injection (Day 0)
Biological: VRC-HIVMAB091-00-AB · Biological: rHuPH20
N6LS (VRC-HIVMAB091-00-AB) is a human monoclonal antibody targeted to the HIV-1 CD4 binding site.
Recombinant human hyaluronidase PH20 (rHuPH20) is the active ingredient of the investigational ENHANZE™ Drug Product (EDP). EDP is a purified preparation of rHuPH20.
Also known as: EDP
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 3 Days of N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20
Participants recorded the occurrence of solicited symptoms on a diary card for 3 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Time frame: 3 days after each product administration, at approximately Day 3 for all dose groups, and at approximately Day 87 and Day 171 for repeat dose groups
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20
Participants recorded the occurrence of solicited symptoms on a diary card for 3 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Time frame: 3 days after each product administration, at approximately Day 3 for all dose groups, and at approximately Day 87 and Day 171 for repeat dose groups
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20
Unsolicited adverse event (AE) data collection included AEs of all severities from the date of product administration through the Day 56 (8 weeks) after each product administration visit. After the Day 56 (8 weeks) after each product administration visit, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that require ongoing medical management (reported as a separate outcome) were recorded through the last study visit. The relationship between a non-serious AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Time frame: Day 0 through 8 weeks after each product administration, at approximately Week 8 for all dose groups, and at Weeks 20 and 32 for repeat dose groups
Number of Participants With Serious Adverse Events (SAEs) Following N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20
SAEs were recorded from receipt of first study product administration through the last expected study visit at Week 24 for single dose groups and at Week 48 for repeat dose groups. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Time frame: Day 0 after product administration through the study participation, up to Week 24 for single dose groups and up to Week 48 for repeat dose groups
Number of Participants With New Chronic Medical Conditions Following N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20
New chronic medical conditions that required ongoing medical management were recorded from receipt of first study product administration through the last expected study visit at Week 24 for single dose groups and at Week 48 for repeat dose groups. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Time frame: Day 0 after product administration through the study participation, up to Week 24 for single dose groups and up to Week 48 for repeat dose groups
Number of Participants With Abnormal Laboratory Measures of Safety Following N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20
Abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV) platelets, and neutrophil, lymphocyte, monocyte, eosinophil and basophil counts) and chemistry (alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, alkaline phosphatase (ALP) and Comprehensive Metabolic Panel (CMP)). Complete Blood Count (CBC) with differential and chemistry (ALT, AST, ALP, creatinine and CMP) results were collected at different timepoints throughout the study per the protocol's schedule of evaluations. Institutional laboratory normal ranges as well as the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 were used.
Time frame: Day 0 through 8 weeks after each product administration, at approximately Week 8 for all dose groups, and at Weeks 20 and 32 for repeat dose groups
Number of Participants Who Produced N6LS Anti-drug Antibodies (ADA) Following N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20
A three-tiered assay was used for ADA evaluation. The tier 1 screening assay measures specific and non-specific binding of serum proteins to N6LS. The tier 2 assay is a qualitative competition assay in which exogenously added N6LS removes any N6LS-binding proteins from the serum prior to the binding assay. If the addition of the exogenous N6LS results in a reduction of signal, the specificity of N6LS binding is confirmed. The tier 3 assay is a qualitative assay that assesses the ability of N6LS-binding serum protein to prevent N6LS-mediated neutralization of an HIV pseudovirus in vitro. Only samples positive for a tier were analyzed in subsequent tiers.
Time frame: Baseline and Weeks 4 and 8 for single dose groups, or Baseline and Weeks 4, 28, and 32 for repeat dose groups
Pharmacokinetic (PK) Parameters of N6LS: Maximum Observed Serum Concentration (Cmax)
Cmax is the peak serum concentration that N6LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.
Time frame: Baseline through the study participation, up to Week 24 for single dose groups and up to Week 48 for repeat dose groups
Pharmacokinetic (PK) Parameters of N6LS: Time to Reach Maximum Observed Serum Concentration (Tmax)
Tmax is the time it takes to reach Cmax of N6LS after it has been administered; it is determined based on the summary PK curve for each dose group.
Time frame: Baseline through the study participation, up to Week 24 for single dose groups and up to Week 48 for repeat dose groups
Pharmacokinetic (PK) Parameters of N6LS: Beta Half-life (T1/2b)
Beta half-life (T1/2b) will be reported for this study. Beta half-life (T1/2b) is the time required for half of the N6LS product to be eliminated from the serum.
Time frame: Baseline through the study participation, up to Week 24 for single dose groups and up to Week 48 for repeat dose groups
Pharmacokinetic (PK) Parameters of N6LS: Clearance Rate
Clearance is the rate of N6LS elimination divided by the plasma N6LS concentration; determined based on the summary pharmacokinetic (PK) curve for each study group. Clearance following a SC administration is calculated as Clearance (CL)/Bioavailability (F).
Time frame: Baseline through the study participation, up to Week 24 for single dose groups and up to Week 48 for repeat dose groups
Pharmacokinetic (PK) Parameters of N6LS: Volume of Distribution
Theoretical volume that would be necessary to contain the total amount of administered drug at the same concentration as observed in plasma. It represents the degree to which a drug is distributed in body tissue rather than the plasma and calculated based in the PK curve for each study group. Volume of distribution following a SC administration is calculated as Volume of distribution (V)/Bioavailability (F).
Time frame: Baseline through the study participation, up to Week 24 for single dose groups and up to Week 48 for repeat dose groups
Healthy adults were recruited for the study at the NIH Clinical Center in Bethesda, Maryland, USA.
| Milestone | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose |
|---|---|---|---|---|---|---|---|---|
| Started | 3 | 4 | 3 | 3 | 5 | 5 | 5 | 5 |
| Received first product administration | 3 | 3 | 3 | 3 | 5 | 5 | 5 | 5 |
| Received all product administrations | 3 | 3 | 3 | 3 | 5 | 5 | 5 | 5 |
| Completed | 3 | 3 | 3 | 3 | 5 | 5 | 4 | 5 |
| Not completed | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Participants recorded the occurrence of solicited symptoms on a diary card for 3 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
| Participants | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose |
|---|---|---|---|---|---|---|---|---|
| Pain/Tenderness — None | 3 | 1 | 3 | 3 | 1 | 5 | 3 | 1 |
| Pain/Tenderness — Mild | 0 | 2 | 0 | 0 | 4 | 0 | 2 | 3 |
| Pain/Tenderness — Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Pain/Tenderness — Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Bruising — None | 3 | 3 | 3 | 3 | 5 | 4 | 5 | 5 |
| Bruising — Mild | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Bruising — Moderate | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Bruising — Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Swelling — None | 3 | 3 | 3 | 3 | 3 | 5 | 4 | 4 |
| Swelling — Mild | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Swelling — Moderate | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Swelling — Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Redness — None | 3 | 3 | 3 | 3 | 3 | 5 | 0 | 0 |
| Redness — Mild | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Redness — Moderate | 0 | 0 | 0 | 0 | 2 | 0 | 3 | 1 |
| Redness — Severe | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 |
| Pruritis (Itching) — None | 3 | 3 | 3 | 3 | 3 | 5 | 4 | 2 |
| Pruritis (Itching) — Mild | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 2 |
| Pruritis (Itching) — Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Pruritis (Itching) — Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any Local Symptom — None | 3 | 1 | 3 | 3 | 1 | 4 | 0 | 0 |
| Any Local Symptom — Mild | 0 | 2 | 0 | 0 | 2 | 0 | 1 | 0 |
| Any Local Symptom — Moderate | 0 | 0 | 0 | 0 | 2 | 1 | 3 | 1 |
| Any Local Symptom — Severe | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 4 |
Participants recorded the occurrence of solicited symptoms on a diary card for 3 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
| Participants | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose |
|---|---|---|---|---|---|---|---|---|
| Malaise — None | 3 | 3 | 2 | 3 | 4 | 5 | 5 | 4 |
| Malaise — Mild | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 |
| Malaise — Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Malaise — Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Myalgia — None | 3 | 3 | 3 | 3 | 4 | 5 | 5 | 5 |
| Myalgia — Mild | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Myalgia — Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Myalgia — Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Headache — None | 2 | 3 | 1 | 2 | 4 | 5 | 5 | 5 |
| Headache — Mild | 1 | 0 | 2 | 1 | 1 | 0 | 0 | 0 |
| Headache — Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Headache — Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Chills — None | 3 | 3 | 3 | 2 | 5 | 5 | 5 | 5 |
| Chills — Mild | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Chills — Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Chills — Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Nausea — None | 3 | 3 | 3 | 2 | 4 | 5 | 5 | 4 |
| Nausea — Mild | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 |
| Nausea — Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Nausea — Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Temperature (Fever) — None | 3 | 3 | 3 | 3 | 5 | 5 | 5 | 5 |
| Temperature (Fever) — Mild | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Temperature (Fever) — Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Temperature (Fever) — Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Joint Pain — None | 3 | 3 | 3 | 3 | 5 | 5 | 5 | 5 |
| Joint Pain — Mild | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Joint Pain — Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Joint Pain — Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any Systemic Symptom — None | 2 | 3 | 1 | 2 | 2 | 5 | 5 | 3 |
| Any Systemic Symptom — Mild | 1 | 0 | 2 | 1 | 3 | 0 | 0 | 2 |
| Any Systemic Symptom — Moderate | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Any Systemic Symptom — Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Unsolicited adverse event (AE) data collection included AEs of all severities from the date of product administration through the Day 56 (8 weeks) after each product administration visit. After the Day 56 (8 weeks) after each product administration visit, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that require ongoing medical management (reported as a separate outcome) were recorded through the last study visit. The relationship between a non-serious AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
| Participants | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose |
|---|---|---|---|---|---|---|---|---|
| Related to Study Product | 0 | 2 | 1 | 0 | 1 | 2 | 0 | 1 |
| Unrelated to Study Product | 1 | 1 | 1 | 2 | 2 | 3 | 2 | 2 |
| Total Number of Participants who had One or More Non-Serious Unsolicited AE | 1 | 3 | 2 | 2 | 3 | 5 | 2 | 3 |
SAEs were recorded from receipt of first study product administration through the last expected study visit at Week 24 for single dose groups and at Week 48 for repeat dose groups. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
| Participants | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose |
|---|---|---|---|---|---|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) Following N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
New chronic medical conditions that required ongoing medical management were recorded from receipt of first study product administration through the last expected study visit at Week 24 for single dose groups and at Week 48 for repeat dose groups. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
| Participants | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose |
|---|---|---|---|---|---|---|---|---|
| Number of Participants With New Chronic Medical Conditions Following N6LS Product Administration Alone or N6LS Co-Administered With rHuPH20 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV) platelets, and neutrophil, lymphocyte, monocyte, eosinophil and basophil counts) and chemistry (alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, alkaline phosphatase (ALP) and Comprehensive Metabolic Panel (CMP)). Complete Blood Count (CBC) with differential and chemistry (ALT, AST, ALP, creatinine and CMP) results were collected at different timepoints throughout the study per the protocol's schedule of evaluations. Institutional laboratory normal ranges as well as the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 were used.
| Participants | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose |
|---|---|---|---|---|---|---|---|---|
| Neutrophil Count | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Alanine aminotransferase (ALT) | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
| Aspartate aminotransferase (AST) | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 |
| Creatinine | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Number of Participants with one or more Abnormal Laboratory Results AE Related to Study Product | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Number of Participants with one or more Abnormal Laboratory Results AE Unrelated to Study Product | 0 | 2 | 0 | 0 | 0 | 1 | 1 | 0 |
| Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs | 0 | 2 | 1 | 0 | 0 | 2 | 1 | 0 |
A three-tiered assay was used for ADA evaluation. The tier 1 screening assay measures specific and non-specific binding of serum proteins to N6LS. The tier 2 assay is a qualitative competition assay in which exogenously added N6LS removes any N6LS-binding proteins from the serum prior to the binding assay. If the addition of the exogenous N6LS results in a reduction of signal, the specificity of N6LS binding is confirmed. The tier 3 assay is a qualitative assay that assesses the ability of N6LS-binding serum protein to prevent N6LS-mediated neutralization of an HIV pseudovirus in vitro. Only samples positive for a tier were analyzed in subsequent tiers.
| Participants | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose |
|---|---|---|---|---|---|---|---|---|
| Tier 1 ADA-Positive Sample | 2 | 2 | 1 | 1 | 2 | 0 | 0 | 0 |
| Tier 2 ADA-Positive Sample | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 |
| Tier 3 ADA-Positive Sample | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Cmax is the peak serum concentration that N6LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.
| μg/ml | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose |
|---|---|---|---|---|---|---|---|---|
| Pharmacokinetic (PK) Parameters of N6LS: Maximum Observed Serum Concentration (Cmax) | 109.0 ± 28.6 | 20.8 ± 1.9 | 492.7 ± 22.9 | 737.3 ± 53.7 | 21.3 ± 5.4 | 411.0 ± 76.7 | 37.3 ± 3.9 | 108.8 ± 40.6 |
Tmax is the time it takes to reach Cmax of N6LS after it has been administered; it is determined based on the summary PK curve for each dose group.
| days | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose |
|---|---|---|---|---|---|---|---|---|
| Pharmacokinetic (PK) Parameters of N6LS: Time to Reach Maximum Observed Serum Concentration (Tmax) | 0.12 ± 0.05 | 2.85 ± 1.02 | 0.12 ± 0.09 | 0.13 ± 0.07 | 6.87 ± 0.07 | 0.03 ± 0.02 | 2.56 ± 0.44 | 4.34 ± 2.38 |
Beta half-life (T1/2b) will be reported for this study. Beta half-life (T1/2b) is the time required for half of the N6LS product to be eliminated from the serum.
| days | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose |
|---|---|---|---|---|---|---|---|---|
| Pharmacokinetic (PK) Parameters of N6LS: Beta Half-life (T1/2b) | 48.7 ± 3.5 | 46.8 ± 1.7 | 50.9 ± 2.3 | 45.3 ± 4.4 | 49.9 ± 4.6 | 46.9 ± 1.9 | 49.2 ± 2.0 | 49.8 ± 6.5 |
Clearance is the rate of N6LS elimination divided by the plasma N6LS concentration; determined based on the summary pharmacokinetic (PK) curve for each study group. Clearance following a SC administration is calculated as Clearance (CL)/Bioavailability (F).
| ml/day | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose |
|---|---|---|---|---|---|---|---|---|
| Pharmacokinetic (PK) Parameters of N6LS: Clearance Rate | 143.1 ± 35.1 | 365.3 ± 108.5 | 142.3 ± 13.3 | 131.0 ± 22.7 | 297.6 ± 60.3 | 148.3 ± 28.3 | 205.9 ± 16.8 | 253.7 ± 102.0 |
Theoretical volume that would be necessary to contain the total amount of administered drug at the same concentration as observed in plasma. It represents the degree to which a drug is distributed in body tissue rather than the plasma and calculated based in the PK curve for each study group. Volume of distribution following a SC administration is calculated as Volume of distribution (V)/Bioavailability (F).
| Liter | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose |
|---|---|---|---|---|---|---|---|---|
| Pharmacokinetic (PK) Parameters of N6LS: Volume of Distribution | 9.6 ± 2.6 | 23.2 ± 6.5 | 9.9 ± 0.4 | 7.9 ± 1.2 | 20.5 ± 2.6 | 9.3 ± 1.5 | 13.5 ± 0.9 | 16.6 ± 5.6 |
Collected over Unsolicited adverse event (AE) data collection included AEs of all severities after each study product administration through the Day 56 (8 weeks) visit. After the Day 56 visit, only serious AEs (SAEs) and new chronic medical conditions that required ongoing medical management were recorded through the study participation, up to Week 24 for single dose groups (1-4 and 7-8, N=22) and up to Week 48 for repeat dose groups (5-6, N=10).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: N6LS (5 mg/kg IV) Single Dose | 0/3 (0%) | 0/3 (0%) | 1/3 (33.3%) |
| Group 2: N6LS (5 mg/kg SC) Single Dose | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Group 3: N6LS (20 mg/kg IV) Single Dose | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Group 4: N6LS (40 mg/kg IV) Single Dose | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Group 5: N6LS (5 mg/kg SC) Repeat Dose | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Group 6: N6LS (20 mg/kg IV) Repeat Dose | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Event | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose |
|---|---|---|---|---|---|---|---|---|
| Administration site erythemaGeneral disorders | 0/3 | 0/3 | 0/3 | 0/3 | 2/5 | 0/5 | 5/5 | 5/5 |
| Administration site painGeneral disorders | 0/3 | 2/3 | 0/3 | 0/3 | 4/5 | 0/5 | 2/5 | 4/5 |
| DiarrhoeaGastrointestinal disorders | 0/3 | 2/3 | 0/3 | 0/3 | 1/5 | 1/5 | 0/5 | 1/5 |
| HeadacheNervous system disorders | 1/3 | 0/3 | 2/3 | 1/3 | 1/5 | 0/5 | 0/5 | 0/5 |
| Administration site pruritusGeneral disorders | 0/3 | 0/3 | 0/3 | 0/3 | 2/5 | 0/5 | 1/5 | 3/5 |
| Upper respiratory tract infectionInfections and infestations | 1/3 | 0/3 | 1/3 | 1/3 | 1/5 | 2/5 | 0/5 | 1/5 |
| Administration site swellingGeneral disorders | 0/3 | 0/3 | 0/3 | 0/3 | 2/5 | 0/5 | 1/5 | 1/5 |
| NeutropeniaBlood and lymphatic system disorders | 0/3 | 0/3 | 1/3 | 0/3 | 0/5 | 0/5 | 0/5 | 0/5 |
| Abdominal painGastrointestinal disorders | 0/3 | 0/3 | 1/3 | 0/3 | 0/5 | 0/5 | 0/5 | 0/5 |
| Administration site bruiseGeneral disorders | 0/3 | 0/3 | 0/3 | 1/3 | 0/5 | 0/5 | 0/5 | 0/5 |
Population included all enrolled participants. Weight represents weight at time of enrollment. Age represents age at enrollment day.
| Age, Continuous(years) | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 30.3 ± 7.4 | 31.3 ± 7.4 | 29.0 ± 6.6 | 28.0 ± 7.8 | 31.0 ± 8.5 | 26.2 ± 7.8 | 37.6 ± 12.5 | 32.8 ± 12.0 | 31.1 ± 9.0 |
| Age, Customized(Participants) | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Total |
|---|---|---|---|---|---|---|---|---|---|
| 21-30 years | 1 | 2 | 2 | 2 | 2 | 4 | 2 | 3 | 18 |
| 31-40 years | 2 | 1 | 1 | 1 | 3 | 1 | 1 | 0 | 10 |
| 41-50 years | 0 | 1 | 0 | 0 | 0 | 0 | 2 | 2 | 5 |
| Sex: Female, Male(Participants) | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 1 | 3 | 1 | 2 | 4 | 3 | 2 | 3 | 19 |
| Male | 2 | 1 | 2 | 1 | 1 | 2 | 3 | 2 | 14 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 3 |
| Not Hispanic or Latino | 3 | 4 | 2 | 2 | 5 | 5 | 4 | 5 | 30 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 0 | 0 | 2 | 1 | 1 | 0 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 4 |
| White | 1 | 2 | 3 | 2 | 2 | 3 | 3 | 4 | 20 |
| More than one race | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Weight (kg)(kg) | Group 1: N6LS (5 mg/kg IV) Single Dose | Group 2: N6LS (5 mg/kg SC) Single Dose | Group 3: N6LS (20 mg/kg IV) Single Dose | Group 4: N6LS (40 mg/kg IV) Single Dose | Group 5: N6LS (5 mg/kg SC) Repeat Dose | Group 6: N6LS (20 mg/kg IV) Repeat Dose | Group 7: N6LS (5 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Group 8: N6LS (20 mg/kg SC) + rHuPH20 (2000 U/ml SC) Single Dose | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 79.9 ± 16.0 | 88.5 ± 17.1 | 90.7 ± 3.2 | 61.7 ± 11.8 | 82.0 ± 15.3 | 74.7 ± 13.8 | 83.9 ± 5.6 | 73.4 ± 9.3 | 79.4 ± 13.6 |
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