Trial Outcomes & Findings for VRC 605: Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or Subcutaneously to Healthy Adults (NCT NCT03015181)

Last Updated: 2020-10-26

Results Overview

Subjects recorded 3-day systemic symptoms in a diary after each study product administration. Solicited systemic symptoms include: unusually tired/feeling unwell, muscles aches, headache, chills, nausea, temperature and joint pain. Subjects recorded highest measured temperature daily. Clinicians reviewed the diary with the subject and collected resolution information for any symptoms that were not resolved within 3 days. Subjects were counted once for each symptom at the worst severity if they indicated experiencing the symptom at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of subjects reporting any systemic symptom at the worst severity. Solicited reactogenicity was recorded without an attribution assessment. Grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

26 participants

Primary outcome timeframe

3 days after each product administration

Results posted on

2020-10-26

Participant Flow

Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland.

Participant milestones

Participant milestones
Measure	Group 1: 1 mg/kg IV Single Dose Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 3: 5 mg/kg SC Single Dose Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.
Overall Study STARTED	4	3	3	3	3	5	5
Overall Study Received VRC07-523LS Per Protocol	3	3	3	3	3	4	4
Overall Study Discontinued VRC07-523LS Administrations	1	0	0	0	0	1	1
Overall Study COMPLETED	3	3	3	3	3	4	4
Overall Study NOT COMPLETED	1	0	0	0	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: 1 mg/kg IV Single Dose Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.
Overall Study Enrolled, but product never administered	1	0	0
Overall Study Withdrawal by Subject	0	1	0
Overall Study Physician Decision	0	0	1

Baseline Characteristics

VRC 605: Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or Subcutaneously to Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: 1 mg/kg IV Single Dose n=4 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=3 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 3: 5 mg/kg SC Single Dose n=3 Participants Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose n=3 Participants Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose n=3 Participants Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses n=5 Participants Group 6 subjects received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses n=5 Participants Group 7 subjects received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0, Week 12 and Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Total n=26 Participants Total of all reporting groups
Age, Continuous	26.5 years STANDARD_DEVIATION 7.0 • n=5 Participants	28.0 years STANDARD_DEVIATION 9.5 • n=7 Participants	30.0 years STANDARD_DEVIATION 7.0 • n=5 Participants	27.0 years STANDARD_DEVIATION 2.6 • n=4 Participants	40.0 years STANDARD_DEVIATION 10.4 • n=21 Participants	25.8 years STANDARD_DEVIATION 4.1 • n=8 Participants	30.0 years STANDARD_DEVIATION 10.6 • n=8 Participants	29.2 years STANDARD_DEVIATION 8.1 • n=24 Participants
Age, Customized 21-30 years	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	18 Participants n=24 Participants
Age, Customized 31-40 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	5 Participants n=24 Participants
Age, Customized 41-50 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=8 Participants	2 Participants n=8 Participants	15 Participants n=24 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants	11 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	4 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	5 Participants n=8 Participants	22 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 Participants
Race/Ethnicity, Customized White	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	16 Participants n=24 Participants
Race/Ethnicity, Customized Multiracial	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	4 Participants n=24 Participants
Weight	75.8 kg STANDARD_DEVIATION 4.6 • n=5 Participants	65.5 kg STANDARD_DEVIATION 17.3 • n=7 Participants	89.4 kg STANDARD_DEVIATION 15.0 • n=5 Participants	75.9 kg STANDARD_DEVIATION 11.0 • n=4 Participants	67.2 kg STANDARD_DEVIATION 20.1 • n=21 Participants	55.2 kg STANDARD_DEVIATION 7.1 • n=8 Participants	76.1 kg STANDARD_DEVIATION 11.4 • n=8 Participants	71.3 kg STANDARD_DEVIATION 14.9 • n=24 Participants
Education High school graduate/GeneralEducationalDevelopment	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants
Education College/University	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	4 Participants n=8 Participants	18 Participants n=24 Participants
Education Advanced degree	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	6 Participants n=24 Participants

PRIMARY outcome

Timeframe: 3 days after each product administration

Population: Subjects who received VRC07-523LS (N=25), where "N" signifies number of subjects analyzed for this outcome measure. Groups 1, 2, 4, 5 and 7 are IV administration groups and Groups 3 and 6 are SC administration groups, with Groups 6 and 7 receiving multiple doses.

Outcome measures

Outcome measures
Measure	Group 1: 1 mg/kg IV Single Dose n=3 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=3 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose n=3 Participants Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose n=3 Participants Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 1 n=5 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 2 n=4 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 3 n=4 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall IV Groups n=17 Participants Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups	Group 3: 5 mg/kg SC Single Dose n=3 Participants Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 1 n=5 Participants Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 2 n=4 Participants Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 3 n=4 Participants Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall SC Groups n=8 Participants Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Malaise · None	3 Participants	3 Participants	3 Participants	2 Participants	3 Participants	3 Participants	3 Participants	14 Participants	3 Participants	2 Participants	4 Participants	4 Participants	5 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Malaise · Mild	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants	2 Participants	0 Participants	3 Participants	0 Participants	0 Participants	3 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Malaise · Moderate	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Myalgia · None	3 Participants	2 Participants	3 Participants	2 Participants	4 Participants	3 Participants	3 Participants	14 Participants	3 Participants	3 Participants	4 Participants	4 Participants	6 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Myalgia · Mild	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Myalgia · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Headache · None	3 Participants	3 Participants	3 Participants	2 Participants	4 Participants	3 Participants	4 Participants	15 Participants	3 Participants	3 Participants	3 Participants	4 Participants	5 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Headache · Mild	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	2 Participants	1 Participants	0 Participants	3 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Headache · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Chills · None	3 Participants	3 Participants	3 Participants	2 Participants	4 Participants	3 Participants	3 Participants	15 Participants	3 Participants	4 Participants	4 Participants	4 Participants	7 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Chills · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Chills · Moderate	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Nausea · None	3 Participants	3 Participants	3 Participants	2 Participants	5 Participants	4 Participants	4 Participants	16 Participants	3 Participants	4 Participants	4 Participants	4 Participants	7 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Nausea · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Nausea · Moderate	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Temperature · None	3 Participants	3 Participants	3 Participants	3 Participants	4 Participants	4 Participants	4 Participants	16 Participants	3 Participants	5 Participants	4 Participants	4 Participants	8 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Temperature · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Temperature · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Joint Pain · None	3 Participants	3 Participants	3 Participants	2 Participants	5 Participants	4 Participants	3 Participants	15 Participants	3 Participants	3 Participants	4 Participants	4 Participants	6 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Joint Pain · Mild	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Joint Pain · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Any Systemic Symptom Reported · None	3 Participants	2 Participants	3 Participants	2 Participants	3 Participants	3 Participants	3 Participants	13 Participants	3 Participants	1 Participants	3 Participants	4 Participants	3 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Any Systemic Symptom Reported · Mild	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	0 Participants	4 Participants	1 Participants	0 Participants	5 Participants
Number of Subjects Reporting Systemic Reactogenicity Signs and Symptoms Within 3 Days of Any Product Administration Any Systemic Symptom Reported · Moderate	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 7 days after each product administration

Local symptoms assessed and recorded by the clinicians. Solicited local symptoms include pain/tenderness, swelling, redness, bruising, and pruritus (itchiness) at the product administration site. Clinicians assessed the study product administration site for local symptoms on the day of product administration after completion of the administration and on Days 1, 2 and 7 post administration. Subjects were counted once for each symptom at the worst severity if they experienced the symptom at any severity during the reporting period. If symptoms were experienced, clinicians collected resolution information for any symptom that was not resolved within 7 days. The number reported for "Any Local Symptom" is the number of subjects reporting any local symptom at the worst severity. Solicited reactogenicity recorded without an attribution assessment. If symptoms were reported, grading was done by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 2.0.

Outcome measures

Outcome measures
Measure	Group 1: 1 mg/kg IV Single Dose n=3 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=3 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose n=3 Participants Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose n=3 Participants Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 1 n=5 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 2 n=4 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 3 n=4 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall IV Groups n=17 Participants Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups	Group 3: 5 mg/kg SC Single Dose n=3 Participants Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 1 n=5 Participants Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 2 n=4 Participants Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 3 n=4 Participants Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall SC Groups n=8 Participants Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Pain/Tenderness · None	3 Participants	3 Participants	2 Participants	3 Participants	5 Participants	4 Participants	4 Participants	16 Participants	2 Participants	2 Participants	1 Participants	2 Participants	4 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Pain/Tenderness · Mild	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants	3 Participants	2 Participants	4 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Pain/Tenderness · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Bruising · None	3 Participants	3 Participants	3 Participants	3 Participants	4 Participants	4 Participants	4 Participants	16 Participants	3 Participants	5 Participants	4 Participants	4 Participants	8 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Bruising · Mild	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Bruising · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Swelling · None	3 Participants	3 Participants	3 Participants	3 Participants	5 Participants	4 Participants	4 Participants	17 Participants	3 Participants	5 Participants	4 Participants	4 Participants	8 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Swelling · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Swelling · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Redness · None	3 Participants	3 Participants	3 Participants	3 Participants	5 Participants	4 Participants	4 Participants	17 Participants	3 Participants	5 Participants	4 Participants	3 Participants	7 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Redness · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Redness · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Pruritus · None	3 Participants	3 Participants	3 Participants	3 Participants	5 Participants	4 Participants	4 Participants	17 Participants	3 Participants	5 Participants	4 Participants	4 Participants	8 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Pruritus · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Pruritus · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Any Local Symptom Reported · None	3 Participants	3 Participants	2 Participants	3 Participants	4 Participants	4 Participants	4 Participants	15 Participants	2 Participants	2 Participants	1 Participants	1 Participants	4 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Any Local Symptom Reported · Mild	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants	3 Participants	3 Participants	2 Participants	3 Participants
Number of Subjects Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Any Product Administration Any Local Symptom Reported · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Through 24 weeks after the last product administration

Population: Subjects who received VRC07-523LS (N=25), where "N" signifies number of subjects analyzed for this outcome measure.

Unsolicited adverse events (AEs) collected during the period from study product administration at Day 0 through 56 days after the last product administration. After the indicated time period through the last expected study visit at 24 weeks after the last product administration, only new chronic medical conditions collected as unsolicited AEs. The number reported is the number of subjects who experienced at least one AE in the reporting period. A subject with multiple experiences of the same event is counted once using the event of worst severity.

Outcome measures

Outcome measures
Measure	Group 1: 1 mg/kg IV Single Dose n=3 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=3 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose n=3 Participants Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose n=3 Participants Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 1 n=3 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 2 n=5 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 3 n=5 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall IV Groups n=25 Participants Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups	Group 3: 5 mg/kg SC Single Dose Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 1 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 2 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 3 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall SC Groups Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events Related to study product	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants	4 Participants	—	—	—	—	—
Number of Subjects Reporting 1 or More Unsolicited Non-Serious Adverse Events Unrelated to study product	2 Participants	1 Participants	1 Participants	0 Participants	0 Participants	5 Participants	3 Participants	12 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Through 24 weeks after the last product administration

Population: Subjects who received VRC07-523LS (N=25), where "N" signifies number of subjects analyzed for this outcome measure.

Serious adverse events (SAEs) collected during the period from study product administration at Day 0 through 24 weeks after the last product administration.

Outcome measures

Outcome measures
Measure	Group 1: 1 mg/kg IV Single Dose n=3 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=3 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose n=3 Participants Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose n=3 Participants Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 1 n=3 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 2 n=5 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 3 n=5 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall IV Groups n=25 Participants Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups	Group 3: 5 mg/kg SC Single Dose Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 1 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 2 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 3 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall SC Groups Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
Number of Subjects Reporting Serious Adverse Events Related to study product	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Number of Subjects Reporting Serious Adverse Events Unrelated to study product	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 24 weeks post product administration

Population: Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS, and represents the first dose only. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV).

Outcome measures

Outcome measures
Measure	Group 1: 1 mg/kg IV Single Dose n=3 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=3 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose n=3 Participants Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose n=4 Participants Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 1 n=3 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 2 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 3 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall IV Groups Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups	Group 3: 5 mg/kg SC Single Dose Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 1 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 2 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 3 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall SC Groups Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Single Dose Groups	47 µg/mL Standard Deviation 16	240 µg/mL Standard Deviation 35	50 µg/mL Standard Deviation 11	869 µg/mL Standard Deviation 190	1630 µg/mL Standard Deviation 644	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through 24 weeks after the last product administration

Cmax is the peak serum concentration that VRC07-523LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group. Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3: Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion

Outcome measures

Outcome measures
Measure	Group 1: 1 mg/kg IV Single Dose n=5 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=4 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 1 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 2 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 3 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall IV Groups Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups	Group 3: 5 mg/kg SC Single Dose Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 1 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 2 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 3 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall SC Groups Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Multiple Dose Groups Dose 1	38 µg/mL Standard Deviation 17	1196 µg/mL Standard Deviation 74	—	—	—	—	—	—	—	—	—	—	—
Maximum Observed Serum Concentration (Cmax) of VRC07-523LS: Multiple Dose Groups Dose 3	37 µg/mL Standard Deviation 12	799 µg/mL Standard Deviation 98	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Through 24 weeks after the last product administration for Groups 1-5 and through 8 weeks after the last product administration for Groups 6 and 7

Tmax is the time it takes to reach Cmax of VRC07-523LS after it has been administered; it is determined based on the summary PK curve for each study group Serum was collected at the following time points: Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion

Outcome measures

Outcome measures
Measure	Group 1: 1 mg/kg IV Single Dose n=3 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=3 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose n=3 Participants Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose n=4 Participants Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 1 n=3 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 2 n=5 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 3 n=4 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall IV Groups Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups	Group 3: 5 mg/kg SC Single Dose Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 1 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 2 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 3 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall SC Groups Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
Time to Reach Maximum Observed Serum Concentration (Tmax) of VRC07-523LS	0.7 days Standard Deviation 0.5	0.04 days Standard Deviation 0.02	10 days Standard Deviation 9.5	0.3 days Standard Deviation 0.4	0.04 days Standard Deviation 0.02	5.7 days Standard Deviation 5.0	0.04 days Standard Deviation 0.02	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 4 post product administration

The mean of individual subject VRC07-523LS serum concentrations by administered dose group

Outcome measures

Outcome measures
Measure	Group 1: 1 mg/kg IV Single Dose n=3 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=3 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose n=3 Participants Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose n=4 Participants Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 1 n=3 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 2 n=5 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 3 n=4 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall IV Groups Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups	Group 3: 5 mg/kg SC Single Dose Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 1 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 2 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 3 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall SC Groups Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
4 Week Mean Serum Concentration of VRC07-523LS	14 µg/mL Standard Deviation 7.5	57 µg/mL Standard Deviation 11	31 µg/mL Standard Deviation 11	148 µg/mL Standard Deviation 28	272 µg/mL Standard Deviation 52	25 µg/mL Standard Deviation 13	242 µg/mL Standard Deviation 51	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Week 12 post product administration

The mean of individual subject VRC07-523LS serum concentrations by administered dose group

Outcome measures

Outcome measures
Measure	Group 1: 1 mg/kg IV Single Dose n=3 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=3 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose n=3 Participants Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose n=4 Participants Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 1 n=3 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 2 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 3 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall IV Groups Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups	Group 3: 5 mg/kg SC Single Dose Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 1 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 2 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 3 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall SC Groups Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
12 Week Mean Serum Concentration of VRC07-523LS: Single Dose Groups	3.8 µg/mL Standard Deviation 0.7	57 µg/mL Standard Deviation 11	7.1 µg/mL Standard Deviation 1.3	44 µg/mL Standard Deviation 14	85 µg/mL Standard Deviation 30	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 12 weeks after each product administration

The mean of individual subject VRC07-523LS serum concentrations by administered dose group

Outcome measures

Outcome measures
Measure	Group 1: 1 mg/kg IV Single Dose n=5 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=4 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 1 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 2 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 3 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall IV Groups Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups	Group 3: 5 mg/kg SC Single Dose Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 1 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 2 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 3 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall SC Groups Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
12 Week Mean Serum Concentration of VRC07-523LS: Multiple Dose Groups Dose 1	6.3 µg/mL Standard Deviation 1.5	46 µg/mL Standard Deviation 13	—	—	—	—	—	—	—	—	—	—	—
12 Week Mean Serum Concentration of VRC07-523LS: Multiple Dose Groups Dose 3	9.8 µg/mL Standard Deviation 2.5	71 µg/mL Standard Deviation 29	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Administration (0h) to 24 weeks post product administration

The total area under the curve (AUC(inf)) was taken as the sum of the observed AUC up to the final concentration (AUC(obs)) plus the AUC after the final concentration (AUC(Clast-inf)) where AUC(Clast-inf) was estimated as Clast/lz. Serum was collected at the following time points: Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4, 8, 12, 16, 20, and 24 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4, 8, 12, 16, 20, and 24 post injection

Outcome measures

Outcome measures
Measure	Group 1: 1 mg/kg IV Single Dose n=3 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=3 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose n=3 Participants Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose n=4 Participants Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 1 n=3 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 2 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 3 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall IV Groups Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups	Group 3: 5 mg/kg SC Single Dose Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 1 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 2 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 3 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall SC Groups Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
Area Under the Curve (AUC(0-inf)): Single Dose Groups	1381 µg*d/mL Standard Deviation 325	4551 µg*d/mL Standard Deviation 904	2189 µg*d/mL Standard Deviation 309	13748 µg*d/mL Standard Deviation 1853	25517 µg*d/mL Standard Deviation 5097	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Administration (0h) up to 84 days after each product administration

The AUC0-84D represents the total drug exposure in 84 days after VRC07-523LS administration; it is determined based on the summary PK curve for each group. Serum was collected at the following time points for Groups 6 and 7 after Dose 1 and Dose 3: Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 6, Dose 3: Pre-injection (Week 24) and 72 hours post injection, followed by Weeks 25-28 and every 4 weeks up to 48 weeks post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hrs post infusion, followed by Weeks 1, 2, 4 and 8 post infusion; Group 7, Dose 3: Pre-infusion (Week 24), end of infusion and 1 hour post infusion followed by Weeks 25-28 and every 4 weeks up to 48 weeks post infusion

Outcome measures

Outcome measures
Measure	Group 1: 1 mg/kg IV Single Dose n=5 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=4 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 1 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 2 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 3 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall IV Groups Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups	Group 3: 5 mg/kg SC Single Dose Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 1 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 2 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 3 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall SC Groups Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
Area Under the Curve (AUC0-84D): Multiple Dose Groups Dose 1	1440 µg*d/mL Standard Deviation 563	14760 µg*d/mL Standard Deviation 2646	—	—	—	—	—	—	—	—	—	—	—
Area Under the Curve (AUC0-84D): Multiple Dose Groups Dose 3	1671 µg*d/mL Standard Deviation 443	13573 µg*d/mL Standard Deviation 1115	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Administration (0h) to 28 days post product administration

Population: Pharmacokinetic (PK) parameters shown for all subjects who received at least one administration of VRC07-523LS. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4 (single dose at 20 mg/kg IV). Value following SC administration represents CL/F (apparent clearance).

Rate of VRC07-523LS elimination divided by the plasma VRC07-523LS concentration; determined based on the summary PK curve for each study group. Serum was collected at the following time points: Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2 and 4 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2 and 4 post infusion

Outcome measures

Outcome measures
Measure	Group 1: 1 mg/kg IV Single Dose n=3 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=3 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose n=4 Participants Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose n=3 Participants Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 1 n=4 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 2 n=17 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 3 n=3 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall IV Groups n=5 Participants Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups	Group 3: 5 mg/kg SC Single Dose n=8 Participants Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 1 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 2 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 3 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall SC Groups Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
VRC07-523LS Clearance Rate	70 mL/day Standard Deviation 20	78 mL/day Standard Deviation 18	110 mL/day Standard Deviation 19	105 mL/day Standard Deviation 14	101 mL/day Standard Deviation 15	94 mL/day Standard Deviation 22	226 mL/day Standard Deviation 54	158 mL/day Standard Deviation 34	184 mL/day Standard Deviation 52	—	—	—	—

SECONDARY outcome

Timeframe: Administration (0h) to 56 days post product administration

Half-life (T1/2) is the time required for half of the drug to be eliminated from the serum. Serum was collected at the following time points: Groups 1, 2, 4, and 5: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1-4 and 8 post infusion; Group 3: Pre-injection (baseline) and 24, 48, 72 hours post injection, and Weeks 1-4 and 8 post injection; Group 6, Dose 1: Pre-injection (baseline) and 24, 48, and 72 hours post injection, followed by Weeks 1, 2, 4 and 8 post injection; Group 7, Dose 1: Pre-infusion (baseline), end of infusion (0h) and 1, 3, 6, 24 and 48 hours post infusion, followed by Weeks 1, 2, 4 and 8 post infusion

Outcome measures

Outcome measures
Measure	Group 1: 1 mg/kg IV Single Dose n=3 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=3 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose n=4 Participants Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose n=3 Participants Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 1 n=4 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 2 n=17 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 3 n=3 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall IV Groups n=5 Participants Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups	Group 3: 5 mg/kg SC Single Dose n=8 Participants Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 1 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 2 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 3 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall SC Groups Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
Overall IV Half-life (T1/2) of VRC07-523LS	48 days Standard Deviation 26	32 days Standard Deviation 1.1	45 days Standard Deviation 5.2	42 days Standard Deviation 5.1	27 days Standard Deviation 1.8	38 days Standard Deviation 12	36 days Standard Deviation 6.7	31 days Standard Deviation 10	33 days Standard Deviation 8.9	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 4 and 8 post product administration

Population: Subjects who received a single dose of VRC07-523LS via SC or IV administration. One subject in Group 7 (multiple doses at 20 mg/kg IV) who only received a single dose was analyzed with Group 4.

Serum samples collected 4 weeks and 8 weeks after VRC07-523LS administration

Outcome measures

Outcome measures
Measure	Group 1: 1 mg/kg IV Single Dose n=3 Participants Group 1 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 1 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 2: 5 mg/kg IV Single Dose n=3 Participants Group 2 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 4: 20 mg/kg IV Single Dose n=3 Participants Group 4 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 5: 40 mg/kg IV Single Dose n=4 Participants Group 5 subjects received a single IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 40 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 1 n=3 Participants Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 2 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 7: 20 mg/kg IV Multiple Doses: Dose 3 Group 7 subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 20 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall IV Groups Total number of subjects who received an IV infusion of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 1, 2, 4, 5 and 7 are IV administration groups	Group 3: 5 mg/kg SC Single Dose Group 3 subjects received a single SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 1 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Day 0 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 2 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 12 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Group 6: 5 mg/kg SC Multiple Doses: Dose 3 Group 6 subjects who received a SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) on Week 24 at a dose of 5 mg/kg. VRC-HIVMAB075-00-AB: VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.	Overall SC Groups Total number of subjects who received an SC injection of VRC07-523LS (VRC-HIVMAB075-00-AB) - Groups 3 and 6 are SC administration groups
Number of Single Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS Week 4: Subjects with Anti-Drug Antibodies	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—
Number of Single Dose Subjects Who Produced Anti-Drug Antibodies to VRC07-523LS Week 8: Subjects with Anti-Drug Antibodies	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Weeks 4, 28 and 32 after the first product administration

Population: Subjects who received multiple doses of VRC07-523LS via SC or IV administration. One subject in Group 7 who only received a single dose was not included in this analysis but was analyzed with Group 4 (single dose at 20 mg/kg IV).

Serum samples collected 4 weeks, 28 weeks and 32 weeks after VRC07-523LS administration