Trial Outcomes & Findings for Trial to Evaluate CIS43LS in Healthy Adults (NCT NCT04206332)

NCT ID: NCT04206332

Last Updated: 2023-04-18

Results Overview

Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after 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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

71 participants

Primary outcome timeframe

7 days after CIS43LS product administration, at approximately Week 1

Results posted on

2023-04-18

Participant Flow

Healthy adults were recruited for Parts A and B of the study at the NIH Clinical Center in Bethesda, Maryland, USA. Healthy adults were recruited for Part C of the study at the University of Maryland, Baltimore Center for Vaccine Development and Global Health, Baltimore, MD, USA.

A subgroup of 10 participants from Part A who continued to Part B is counted twice: 4 Part A participants received a 2nd CIS43LS dose of 20 mg/kg IV in Part B (1 received 5 mg/kg IV, 1 received 5 mg/kg SC, and 2 received 20 mg/kg IV in Part A) and 6 did not receive CIS43LS in Part B: 3 enrolled as back up in the 20 mg/kg IV group (1 received 5 mg/kg IV, 1 received 5 mg/kg SC and 1 received 20 mg/kg IV in Part A) and 3 enrolled in CHMI (2 received 40 mg/kg IV and 1 enrolled in CHMI in Part A)

Participant milestones

Participant milestones
Measure	Part A, Group 1: CIS43LS (5 mg/kg IV) CIS43LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 2: CIS43LS (5 mg/kg SC) CIS43LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 3: CIS43LS (20 mg/kg IV) CIS43LS (20 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4A: CIS43LS (40 mg/kg IV) CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4B: CIS43LS (40 mg/kg IV) CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 5: CHMI Controls Control participants who did not receive CIS43LS and were enrolled to complete the controlled human malaria infection (CHMI); however, Group 5 did not undergo CHMI because of restrictions related to coronavirus disease 2019 (COVID-19)	Part B, Group 7: CIS43LS (20 mg/kg IV) CIS43LS (20 mg/kg) administered by IV infusion (Day 0) Part B, Group 7 participants included participants previously enrolled in Part A who received either 5 mg/kg IV (1), 5 mg/kg SC (1) or 20 mg/kg IV (2) in the first part of the study and newly enrolled Part B participants VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part B, Group 8: CHMI [CIS43LS (40 mg/kg IV) in Part A] Part B, Group 8 participants included participants previously enrolled in Part A who received CIS43LS (40 mg/kg IV) in the first part of the study but did not receive CIS43LS in Part B of the study. Group 8 participants were enrolled to complete the controlled human malaria infection (CHMI). Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part B, Group 9: CIS43LS (40 mg/kg IV) CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part B, Group 10: CHMI Controls Control participants who did not receive CIS43LS and were enrolled to complete the controlled human malaria infection (CHMI) Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 11: CIS43LS (1 mg/kg IV) CIS43LS (1 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 12: CIS43LS (5 mg/kg IV) CIS43LS (5 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 13: CIS43LS (5 mg/kg SC) CIS43LS (5 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 14: CIS43LS (10 mg/kg IV) CIS43LS (10 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 15: CIS43LS (10 mg/kg SC) CIS43LS (10 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 16: CHMI Controls Control participants who did not receive CIS43LS and were enrolled to complete the controlled human malaria infection (CHMI) Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).
Part A STARTED	4	4	5	5	3	8	0	0	0	0	0	0	0	0	0	0
Part A Received Product Administration	4	4	5	5	3	0	0	0	0	0	0	0	0	0	0	0
Part A Completed Controlled Human Malaria Infection (CHMI)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Part A COMPLETED	4	3	5	5	3	0	0	0	0	0	0	0	0	0	0	0
Part A NOT COMPLETED	0	1	0	0	0	8	0	0	0	0	0	0	0	0	0	0
Part B STARTED	0	0	0	0	0	0	7	2	4	8	0	0	0	0	0	0
Part B Received Product Administration	0	0	0	0	0	0	4	0	4	0	0	0	0	0	0	0
Part B Completed Controlled Human Malaria Infection (CHMI)	0	0	0	0	0	0	4	2	3	6	0	0	0	0	0	0
Part B COMPLETED	0	0	0	0	0	0	4	2	4	6	0	0	0	0	0	0
Part B NOT COMPLETED	0	0	0	0	0	0	3	0	0	2	0	0	0	0	0	0
Part C STARTED	0	0	0	0	0	0	0	0	0	0	7	4	4	4	4	8
Part C Received Product Administration	0	0	0	0	0	0	0	0	0	0	7	4	4	3	4	0
Part C Completed Controlled Human Malaria Infection (CHMI)	0	0	0	0	0	0	0	0	0	0	7	4	4	3	4	6
Part C COMPLETED	0	0	0	0	0	0	0	0	0	0	7	4	4	2	4	6
Part C NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A, Group 2: CIS43LS (5 mg/kg SC) CIS43LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 5: CHMI Controls Control participants who did not receive CIS43LS and were enrolled to complete the controlled human malaria infection (CHMI); however, Group 5 did not undergo CHMI because of restrictions related to coronavirus disease 2019 (COVID-19)	Part B, Group 7: CIS43LS (20 mg/kg IV) CIS43LS (20 mg/kg) administered by IV infusion (Day 0) Part B, Group 7 participants included participants previously enrolled in Part A who received either 5 mg/kg IV (1), 5 mg/kg SC (1) or 20 mg/kg IV (2) in the first part of the study and newly enrolled Part B participants VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part B, Group 10: CHMI Controls Control participants who did not receive CIS43LS and were enrolled to complete the controlled human malaria infection (CHMI) Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 14: CIS43LS (10 mg/kg IV) CIS43LS (10 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 16: CHMI Controls Control participants who did not receive CIS43LS and were enrolled to complete the controlled human malaria infection (CHMI) Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).
Part A Lost to Follow-up	1	0	0	0	0	0
Part A CHMI canceled because of restrictions related to coronavirus disease 2019 (COVID-19)	0	8	0	0	0	0
Part B Back up participants who did not receive CIS43LS or CHMI because they were not needed	0	0	3	2	0	0
Part C Back up participants who did not receive CIS43LS or CHMI because they were not needed	0	0	0	0	0	2
Part C Withdrawal by Subject	0	0	0	0	2	0

Baseline Characteristics

Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A, Group 1: CIS43LS (5 mg/kg IV) n=4 Participants CIS43LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 2: CIS43LS (5 mg/kg SC) n=4 Participants CIS43LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 3: CIS43LS (20 mg/kg IV) n=5 Participants CIS43LS (20 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4A: CIS43LS (40 mg/kg IV) n=5 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4B: CIS43LS (40 mg/kg IV) n=3 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 5: CHMI Controls n=8 Participants Control participants who did not receive CIS43LS and were enrolled to complete the controlled human malaria infection (CHMI); however, Group 5 did not undergo CHMI because of restrictions related to coronavirus disease 2019 (COVID-19)	Part B, Group 6: CIS43LS (5 mg/kg SC) CIS43LS (5 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part B, Group 7: CIS43LS (20 mg/kg IV) n=7 Participants CIS43LS (20 mg/kg) administered by IV infusion (Day 0) Part B, Group 7 participants included participants previously enrolled in Part A who received either 5 mg/kg IV (1), 5 mg/kg SC (1) or 20 mg/kg IV (2) in the first part of the study and newly enrolled Part B participants VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part B, Group 8: CHMI [CIS43LS (40 mg/kg IV) in Part A] n=2 Participants Part B, Group 8 participants included participants previously enrolled in Part A who received CIS43LS (40 mg/kg IV) in the first part of the study but did not receive CIS43LS in Part B of the study. Group 8 participants were enrolled to complete the controlled human malaria infection (CHMI). Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part B, Group 9: CIS43LS (40 mg/kg IV) n=4 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part B, Group 10: CHMI Controls n=8 Participants Control participants who did not receive CIS43LS and were enrolled to complete the controlled human malaria infection (CHMI) Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 11: CIS43LS (1 mg/kg IV) n=7 Participants CIS43LS (1 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 12: CIS43LS (5 mg/kg IV) n=4 Participants CIS43LS (5 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 13: CIS43LS (5 mg/kg SC) n=4 Participants CIS43LS (5 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 14: CIS43LS (10 mg/kg IV) n=4 Participants CIS43LS (10 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 15: CIS43LS (10 mg/kg SC) n=4 Participants CIS43LS (10 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 16: CHMI Controls n=8 Participants Control participants who did not receive CIS43LS and were enrolled to complete the controlled human malaria infection (CHMI) Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Total n=81 Participants Total of all reporting groups
Race/Ethnicity, Customized Part B · White	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=2 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	9 Participants n=21 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Race/Ethnicity, Customized Part B · Multiracial	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=2 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=21 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Race/Ethnicity, Customized Part C · Asian	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=31 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Race/Ethnicity, Customized Part C · Black or African American	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	6 Participants n=31 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Race/Ethnicity, Customized Part C · White	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	6 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	7 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	24 Participants n=31 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Race/Ethnicity, Customized Part C · Multiracial	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=31 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Age, Customized Part B · 18-20 years	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=2 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=21 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Age, Continuous Part A	26.5 years STANDARD_DEVIATION 5.1 • n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	23.5 years STANDARD_DEVIATION 3.7 • n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	29.4 years STANDARD_DEVIATION 5.4 • n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	35.0 years STANDARD_DEVIATION 10.2 • n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	25.3 years STANDARD_DEVIATION 4.0 • n=3 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	30.5 years STANDARD_DEVIATION 8.9 • n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	—	—	—	—	—	—	—	—	—	—	—	29.0 years STANDARD_DEVIATION 7.6 • n=29 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Age, Continuous Part B	—	—	—	—	—	—	—	25.1 years STANDARD_DEVIATION 4.2 • n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	31.5 years STANDARD_DEVIATION 10.6 • n=2 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	26.8 years STANDARD_DEVIATION 3.4 • n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	30.1 years STANDARD_DEVIATION 4.5 • n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	—	—	—	—	—	—	28.0 years STANDARD_DEVIATION 5.1 • n=21 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Age, Continuous Part C	—	—	—	—	—	—	—	—	—	—	—	38.6 years STANDARD_DEVIATION 8.7 • n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	30.5 years STANDARD_DEVIATION 5.6 • n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	37.3 years STANDARD_DEVIATION 7.4 • n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	31.0 years STANDARD_DEVIATION 7.6 • n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	28.3 years STANDARD_DEVIATION 3.3 • n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	32.5 years STANDARD_DEVIATION 9.7 • n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	33.5 years STANDARD_DEVIATION 8.1 • n=31 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Age, Customized Part A · 18-20 years	1 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=3 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=29 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Age, Customized Part A · 21-30 years	3 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=3 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	5 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	20 Participants n=29 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Age, Customized Part A · 31-40 years	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=3 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	6 Participants n=29 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Age, Customized Part A · 41-50 years	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=3 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=29 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Age, Customized Part B · 21-30 years	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	5 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=2 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	5 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	15 Participants n=21 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Age, Customized Part B · 31-40 years	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=2 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	5 Participants n=21 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Age, Customized Part B · 41-50 years	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	—	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=2 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=21 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Age, Customized Part C · 18-20 years	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=31 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Age, Customized Part C · 21-30 years	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	12 Participants n=31 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Age, Customized Part C · 31-40 years	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	11 Participants n=31 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Age, Customized Part C · 41-50 years	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	7 Participants n=31 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Sex: Female, Male Part A · Female	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=3 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	7 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	17 Participants n=29 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Sex: Female, Male Part A · Male	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=3 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	12 Participants n=29 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Sex: Female, Male Part B · Female	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=2 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	6 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	11 Participants n=21 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Sex: Female, Male Part B · Male	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=2 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	10 Participants n=21 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Sex: Female, Male Part C · Female	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	18 Participants n=31 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Sex: Female, Male Part C · Male	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	13 Participants n=31 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Ethnicity (NIH/OMB) Part A · Hispanic or Latino	1 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=3 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=29 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Ethnicity (NIH/OMB) Part A · Not Hispanic or Latino	3 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	5 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=3 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	7 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	26 Participants n=29 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Ethnicity (NIH/OMB) Part A · Unknown or Not Reported	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=3 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=29 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Ethnicity (NIH/OMB) Part B · Hispanic or Latino	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=2 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=21 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Ethnicity (NIH/OMB) Part B · Not Hispanic or Latino	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	6 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=2 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	7 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	19 Participants n=21 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Ethnicity (NIH/OMB) Part B · Unknown or Not Reported	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=2 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=21 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Ethnicity (NIH/OMB) Part C · Hispanic or Latino	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=31 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Ethnicity (NIH/OMB) Part C · Not Hispanic or Latino	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	7 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	8 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	30 Participants n=31 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Ethnicity (NIH/OMB) Part C · Unknown or Not Reported	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=31 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Race/Ethnicity, Customized Part A · Asian	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=3 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	5 Participants n=29 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Race/Ethnicity, Customized Part A · Black or African American	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=3 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=29 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Race/Ethnicity, Customized Part A · White	4 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	4 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=3 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	6 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	21 Participants n=29 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Race/Ethnicity, Customized Part A · Multiracial	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=5 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=3 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=29 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Race/Ethnicity, Customized Part B · Asian	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	3 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=2 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	7 Participants n=21 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Race/Ethnicity, Customized Part B · Black or African American	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=7 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=2 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants n=4 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	1 Participants n=8 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	0 Participants Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").	2 Participants n=21 Participants • Each row population reports Baseline Characteristics data separately for each part of the study (e.g., "Part A", "Part B", and "Part C").
Weight (kg) Part A	67.1 kg STANDARD_DEVIATION 8.8 • n=4 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	70.5 kg STANDARD_DEVIATION 15.1 • n=4 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	74.4 kg STANDARD_DEVIATION 14.7 • n=5 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	73.8 kg STANDARD_DEVIATION 12.7 • n=5 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	66.2 kg STANDARD_DEVIATION 19.5 • n=3 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	66.9 kg STANDARD_DEVIATION 14.8 • n=8 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	—	—	—	—	—	—	—	—	—	—	—	69.8 kg STANDARD_DEVIATION 13.4 • n=29 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.
Weight (kg) Part B	—	—	—	—	—	—	—	65.0 kg STANDARD_DEVIATION 13.4 • n=7 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	72.1 kg STANDARD_DEVIATION 1.3 • n=2 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	75.9 kg STANDARD_DEVIATION 13.5 • n=4 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	74.9 kg STANDARD_DEVIATION 16.0 • n=8 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	—	—	—	—	—	—	71.1 kg STANDARD_DEVIATION 13.8 • n=21 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.
Weight (kg) Part C	—	—	—	—	—	—	—	—	—	—	—	75.6 kg STANDARD_DEVIATION 18.9 • n=7 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	70.8 kg STANDARD_DEVIATION 3.2 • n=4 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	85.5 kg STANDARD_DEVIATION 14.5 • n=4 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	66.6 kg STANDARD_DEVIATION 4.1 • n=3 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	74.6 kg STANDARD_DEVIATION 19.5 • n=4 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	70.8 kg STANDARD_DEVIATION 14.0 • n=8 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.	75.1 kg STANDARD_DEVIATION 15.0 • n=30 Participants • Each row population reports baseline characteristics data separately for each part of the study. Part C: A total of 22 weights were collected at enrollment and included in the overall weight measurement: one Group 14 participant withdrew prior to product administration and weight collection, and 8 Group 16 participants had weight collected during screening but not at enrollment. Weight collected for Group 16 participants in the screening protocol is excluded from the overall weight evaluation.

PRIMARY outcome

Timeframe: 7 days after CIS43LS product administration, at approximately Week 1

Population: Population included all enrolled participants who received CIS43LS and provided safety data (via diary card). A subgroup of 4 participants from Part A who continued to Part B are counted twice, and received a second CIS43LS dose intravenously (IV): 4 received CIS43LS at a dose of 20 mg/kg IV in Part B (1 had previously received 5 mg/kg IV, 1 had received 5 mg/kg subcutaneously, and 2 had received 20 mg/kg IV). No participants enrolled in Group 6: CIS43LS (5 mg/kg SC).

Outcome measures

Outcome measures
Measure	Part A, Group 1: CIS43LS (5 mg/kg IV) n=4 Participants CIS43LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 2: CIS43LS (5 mg/kg SC) n=4 Participants CIS43LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 3: CIS43LS (20 mg/kg IV) n=5 Participants CIS43LS (20 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4A: CIS43LS (40 mg/kg IV) n=5 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4B: CIS43LS (40 mg/kg IV) n=3 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part B, Group 7: CIS43LS (20 mg/kg IV) n=4 Participants CIS43LS (20 mg/kg) administered by IV infusion (Day 0) Part B, Group 7 participants included participants previously enrolled in Part A who received either 5 mg/kg IV (1), 5 mg/kg SC (1) or 20 mg/kg IV (2) in the first part of the study and newly enrolled Part B participants VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part B, Group 9: CIS43LS (40 mg/kg IV) n=4 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 11: CIS43LS (1 mg/kg IV) n=7 Participants CIS43LS (1 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 12: CIS43LS (5 mg/kg IV) n=4 Participants CIS43LS (5 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 13: CIS43LS (5 mg/kg SC) n=4 Participants CIS43LS (5 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 14: CIS43LS (10 mg/kg IV) n=3 Participants CIS43LS (10 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 15: CIS43LS (10 mg/kg SC) n=4 Participants CIS43LS (10 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Pain/Tenderness · None	4 Participants	1 Participants	5 Participants	3 Participants	3 Participants	2 Participants	4 Participants	4 Participants	4 Participants	4 Participants	3 Participants	3 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Pain/Tenderness · Mild	0 Participants	3 Participants	0 Participants	2 Participants	0 Participants	2 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS 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
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Pain/Tenderness · Severe	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 Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Pruritis (Itching) · None	4 Participants	4 Participants	5 Participants	5 Participants	3 Participants	4 Participants	4 Participants	7 Participants	4 Participants	4 Participants	3 Participants	3 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Pruritis (Itching) · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Pruritis (Itching) · 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
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Pruritis (Itching) · Severe	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 Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Swelling · None	4 Participants	4 Participants	5 Participants	5 Participants	3 Participants	4 Participants	4 Participants	7 Participants	4 Participants	4 Participants	3 Participants	4 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS 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
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS 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
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS 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	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Swelling · Severe	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 Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Redness · None	4 Participants	4 Participants	5 Participants	5 Participants	3 Participants	4 Participants	4 Participants	6 Participants	4 Participants	4 Participants	3 Participants	4 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Redness · Severe	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 Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Redness · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Bruising · None	4 Participants	4 Participants	5 Participants	4 Participants	3 Participants	4 Participants	4 Participants	7 Participants	4 Participants	4 Participants	3 Participants	4 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Bruising · 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
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Bruising · Moderate	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Bruising · Severe	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 Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Any Local Symptom · None	4 Participants	1 Participants	5 Participants	3 Participants	3 Participants	2 Participants	4 Participants	4 Participants	4 Participants	4 Participants	3 Participants	2 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Any Local Symptom · Mild	0 Participants	3 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Any Local Symptom · Moderate	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Any Local Symptom · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 7 days after CIS43LS product administration, at approximately Week 1

Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after 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 systemic 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.

Outcome measures

Outcome measures
Measure	Part A, Group 1: CIS43LS (5 mg/kg IV) n=4 Participants CIS43LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 2: CIS43LS (5 mg/kg SC) n=4 Participants CIS43LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 3: CIS43LS (20 mg/kg IV) n=5 Participants CIS43LS (20 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4A: CIS43LS (40 mg/kg IV) n=5 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4B: CIS43LS (40 mg/kg IV) n=3 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part B, Group 7: CIS43LS (20 mg/kg IV) n=4 Participants CIS43LS (20 mg/kg) administered by IV infusion (Day 0) Part B, Group 7 participants included participants previously enrolled in Part A who received either 5 mg/kg IV (1), 5 mg/kg SC (1) or 20 mg/kg IV (2) in the first part of the study and newly enrolled Part B participants VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part B, Group 9: CIS43LS (40 mg/kg IV) n=4 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 11: CIS43LS (1 mg/kg IV) n=7 Participants CIS43LS (1 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 12: CIS43LS (5 mg/kg IV) n=4 Participants CIS43LS (5 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 13: CIS43LS (5 mg/kg SC) n=4 Participants CIS43LS (5 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 14: CIS43LS (10 mg/kg IV) n=3 Participants CIS43LS (10 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 15: CIS43LS (10 mg/kg SC) n=4 Participants CIS43LS (10 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Malaise · None	4 Participants	4 Participants	5 Participants	4 Participants	3 Participants	2 Participants	4 Participants	6 Participants	3 Participants	3 Participants	2 Participants	3 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Malaise · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Malaise · Moderate	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Malaise · Severe	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 Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Muscle Aches · None	4 Participants	2 Participants	4 Participants	3 Participants	3 Participants	4 Participants	4 Participants	6 Participants	3 Participants	4 Participants	3 Participants	3 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Muscle Aches · Mild	0 Participants	2 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Muscle Aches · Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Muscle Aches · Severe	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 Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Headache · None	3 Participants	3 Participants	3 Participants	4 Participants	2 Participants	4 Participants	3 Participants	6 Participants	3 Participants	4 Participants	2 Participants	2 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Headache · Mild	0 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Headache · Moderate	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Headache · Severe	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 Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Chills · None	4 Participants	4 Participants	5 Participants	5 Participants	3 Participants	4 Participants	4 Participants	7 Participants	4 Participants	4 Participants	3 Participants	4 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Chills · 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
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Chills · 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
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Chills · Severe	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 Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Nausea · None	3 Participants	4 Participants	5 Participants	5 Participants	3 Participants	3 Participants	4 Participants	5 Participants	4 Participants	4 Participants	3 Participants	4 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Nausea · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Nausea · Moderate	1 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 Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Nausea · Severe	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 Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Joint Pain · None	4 Participants	4 Participants	5 Participants	4 Participants	3 Participants	4 Participants	4 Participants	7 Participants	3 Participants	4 Participants	3 Participants	3 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Joint Pain · Mild	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Joint Pain · 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
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Joint Pain · Severe	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 Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Temperature (Fever) · None	4 Participants	4 Participants	5 Participants	5 Participants	3 Participants	4 Participants	3 Participants	7 Participants	4 Participants	4 Participants	3 Participants	4 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Temperature (Fever) · Mild	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Temperature (Fever) · 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
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Temperature (Fever) · Severe	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 Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Any Systemic Symptom · None	3 Participants	1 Participants	3 Participants	2 Participants	2 Participants	2 Participants	2 Participants	5 Participants	3 Participants	3 Participants	2 Participants	2 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Any Systemic Symptom · Mild	0 Participants	3 Participants	2 Participants	2 Participants	1 Participants	2 Participants	2 Participants	1 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Any Systemic Symptom · Moderate	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of CIS43LS Product Administration Any Systemic Symptom · Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0 through 4 weeks after CIS43LS product administration

Population: Population included all enrolled participants who received CIS43LS and had safety data collected (via clinical assessment and/or lab results). A subgroup of 4 participants from Part A who continued to Part B are counted twice, and received a second CIS43LS dose intravenously (IV): 4 received CIS43LS at a dose of 20 mg/kg IV in Part B (1 had previously received 5 mg/kg IV, 1 received 5 mg/kg subcutaneously, and 2 received 20 mg/kg IV). No participants enrolled in Group 6: CIS43LS (5 mg/kg SC).

Unsolicited adverse event (AE) data collection included AEs of all severities from the date of product administration through the Day 28 post-product administration visit. At other time periods between study product administration and when greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions that required ongoing medical management (reported as a separate outcome) were recorded through the last study visit. The relationship between an 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.

Outcome measures

Outcome measures
Measure	Part A, Group 1: CIS43LS (5 mg/kg IV) n=4 Participants CIS43LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 2: CIS43LS (5 mg/kg SC) n=4 Participants CIS43LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 3: CIS43LS (20 mg/kg IV) n=5 Participants CIS43LS (20 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4A: CIS43LS (40 mg/kg IV) n=5 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4B: CIS43LS (40 mg/kg IV) n=3 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part B, Group 7: CIS43LS (20 mg/kg IV) n=4 Participants CIS43LS (20 mg/kg) administered by IV infusion (Day 0) Part B, Group 7 participants included participants previously enrolled in Part A who received either 5 mg/kg IV (1), 5 mg/kg SC (1) or 20 mg/kg IV (2) in the first part of the study and newly enrolled Part B participants VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part B, Group 9: CIS43LS (40 mg/kg IV) n=4 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 11: CIS43LS (1 mg/kg IV) n=7 Participants CIS43LS (1 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 12: CIS43LS (5 mg/kg IV) n=4 Participants CIS43LS (5 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 13: CIS43LS (5 mg/kg SC) n=4 Participants CIS43LS (5 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 14: CIS43LS (10 mg/kg IV) n=3 Participants CIS43LS (10 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 15: CIS43LS (10 mg/kg SC) n=4 Participants CIS43LS (10 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following CIS43LS Product Administration Related to Study Product	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following CIS43LS Product Administration Unrelated to Study Product	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants	4 Participants
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following CIS43LS Product Administration Total Number of Participants who had One or More Non-Serious Unsolicited AE after CIS43LS	4 Participants	0 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	3 Participants	0 Participants	2 Participants	2 Participants	4 Participants

PRIMARY outcome

Timeframe: Day 0 through 4 weeks after CHMI

Population: Population included all enrolled participants who completed CHMI and had safety data collected (via clinical assessment and/or laboratory results). Part A participants did not complete CHMI because of restrictions related to coronavirus disease 2019 (COVID-19). No participants enrolled in Part B, Group 6: CIS43LS (5 mg/kg SC).

Unsolicited adverse event (AE) data collection included AEs of all severities from CHMI through the Day 28 post-CHMI visit. The relationship between an AE and CHMI 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.

Outcome measures

Outcome measures
Measure	Part A, Group 1: CIS43LS (5 mg/kg IV) n=4 Participants CIS43LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 2: CIS43LS (5 mg/kg SC) n=2 Participants CIS43LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 3: CIS43LS (20 mg/kg IV) n=3 Participants CIS43LS (20 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4A: CIS43LS (40 mg/kg IV) n=6 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4B: CIS43LS (40 mg/kg IV) n=7 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part B, Group 7: CIS43LS (20 mg/kg IV) n=4 Participants CIS43LS (20 mg/kg) administered by IV infusion (Day 0) Part B, Group 7 participants included participants previously enrolled in Part A who received either 5 mg/kg IV (1), 5 mg/kg SC (1) or 20 mg/kg IV (2) in the first part of the study and newly enrolled Part B participants VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part B, Group 9: CIS43LS (40 mg/kg IV) n=4 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 11: CIS43LS (1 mg/kg IV) n=3 Participants CIS43LS (1 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 12: CIS43LS (5 mg/kg IV) n=4 Participants CIS43LS (5 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 13: CIS43LS (5 mg/kg SC) n=6 Participants CIS43LS (5 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 14: CIS43LS (10 mg/kg IV) CIS43LS (10 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 15: CIS43LS (10 mg/kg SC) CIS43LS (10 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Controlled Human Malaria Infection (CHMI) Related to CHMI	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	—	—
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Controlled Human Malaria Infection (CHMI) Unrelated to CHMI	1 Participants	0 Participants	0 Participants	1 Participants	3 Participants	2 Participants	3 Participants	2 Participants	3 Participants	0 Participants	—	—
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Controlled Human Malaria Infection (CHMI) Total Number of Participants who had One or More Non-Serious Unsolicited AE after CHMI	1 Participants	0 Participants	0 Participants	1 Participants	4 Participants	2 Participants	4 Participants	2 Participants	4 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Day 0 after CIS43LS product administration through the study participation, up to Week 24

SAEs were recorded from receipt of first study product administration through the last expected study visit at Week 24. 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.

Outcome measures

Outcome measures
Measure	Part A, Group 1: CIS43LS (5 mg/kg IV) n=4 Participants CIS43LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 2: CIS43LS (5 mg/kg SC) n=4 Participants CIS43LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 3: CIS43LS (20 mg/kg IV) n=5 Participants CIS43LS (20 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4A: CIS43LS (40 mg/kg IV) n=5 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4B: CIS43LS (40 mg/kg IV) n=3 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part B, Group 7: CIS43LS (20 mg/kg IV) n=4 Participants CIS43LS (20 mg/kg) administered by IV infusion (Day 0) Part B, Group 7 participants included participants previously enrolled in Part A who received either 5 mg/kg IV (1), 5 mg/kg SC (1) or 20 mg/kg IV (2) in the first part of the study and newly enrolled Part B participants VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part B, Group 9: CIS43LS (40 mg/kg IV) n=4 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 11: CIS43LS (1 mg/kg IV) n=7 Participants CIS43LS (1 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 12: CIS43LS (5 mg/kg IV) n=4 Participants CIS43LS (5 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 13: CIS43LS (5 mg/kg SC) n=4 Participants CIS43LS (5 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 14: CIS43LS (10 mg/kg IV) n=3 Participants CIS43LS (10 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 15: CIS43LS (10 mg/kg SC) n=4 Participants CIS43LS (10 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).
Number of Participants With Serious Adverse Events (SAEs) Following CIS43LS Product Administration Related to Study Product	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 Participants With Serious Adverse Events (SAEs) Following CIS43LS Product Administration Unrelated to Study Product	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Serious Adverse Events (SAEs) Following CIS43LS Product Administration Total number of Participants With SAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0 after CIS43LS product administration through the study participation, up to Week 24

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. 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.

Outcome measures

Outcome measures
Measure	Part A, Group 1: CIS43LS (5 mg/kg IV) n=4 Participants CIS43LS (5 mg/kg) administered by intravenous (IV) infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 2: CIS43LS (5 mg/kg SC) n=4 Participants CIS43LS (5 mg/kg) administered by subcutaneous (SC) injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 3: CIS43LS (20 mg/kg IV) n=5 Participants CIS43LS (20 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4A: CIS43LS (40 mg/kg IV) n=5 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part A, Group 4B: CIS43LS (40 mg/kg IV) n=3 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.	Part B, Group 7: CIS43LS (20 mg/kg IV) n=4 Participants CIS43LS (20 mg/kg) administered by IV infusion (Day 0) Part B, Group 7 participants included participants previously enrolled in Part A who received either 5 mg/kg IV (1), 5 mg/kg SC (1) or 20 mg/kg IV (2) in the first part of the study and newly enrolled Part B participants VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part B, Group 9: CIS43LS (40 mg/kg IV) n=4 Participants CIS43LS (40 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 11: CIS43LS (1 mg/kg IV) n=7 Participants CIS43LS (1 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 12: CIS43LS (5 mg/kg IV) n=4 Participants CIS43LS (5 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 13: CIS43LS (5 mg/kg SC) n=4 Participants CIS43LS (5 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 14: CIS43LS (10 mg/kg IV) n=3 Participants CIS43LS (10 mg/kg) administered by IV infusion (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).	Part C, Group 15: CIS43LS (10 mg/kg SC) n=4 Participants CIS43LS (10 mg/kg) administered by SC injection (Day 0) VRC-MALMAB0100-00-AB: VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma. Plasmodium falciparum (P. falciparum) sporozoite challenge: Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).
Number of Participants With New Chronic Medical Conditions Following CIS43LS Product Administration	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 0 through 4 weeks after CIS43LS product administration

Population: Population included all enrolled participants who received CIS43LS and had safety data collected via laboratory results. A subgroup of 4 participants from Part A who continued to Part B are counted twice, and received a second CIS43LS dose intravenously (IV): 4 received CIS43LS at a dose of 20 mg/kg IV in Part B (1 had previously received 5 mg/kg IV, 1 had received 5 mg/kg subcutaneously, and 2 had received 20 mg/kg IV). No participants enrolled in Group 6: CIS43LS (5 mg/kg SC).

Abnormal laboratory results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included hematology (hemoglobin, hematocrit, mean corpuscular volume (MCV) platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil counts) and chemistry (alanine aminotransferase (ALT) and creatinine). Complete Blood Count (CBC) with differential and Chemistry (ALT and creatinine) results were collected at different timepoints in Parts A, B and C 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.