Trial Outcomes & Findings for A Study of MGD020 Alone or Combined With MGD014 in Persons With HIV-1 on Antiretroviral Therapy (NCT NCT05261191)

NCT ID: NCT05261191

Last Updated: 2025-03-28

Results Overview

Observation of side effects determines the highest safe dose for further study

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 17 participants
• Primary outcome timeframe: Throughout the study, up to 43 days
• Results posted on: 2025-03-28

Participant Flow

Participants who completed treatment in Part 1A or Part 1B may be considered for treatment in a subsequent cohort in Part B2 or Part 2. Participants must continue to meet all eligibility criteria, not have experienced severe adverse events in Part 1, and do not have detectable antidrug antibodies against prior study treatment. Subsequent treatments assignments are not defined in advance when entering the study.

Participant milestones

Measure	Part 1A: Cohort 1 Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Part 1A STARTED	1	1	1	3	3	6	0	0	0
Part 1A Participant Treated in 1A Cohort 2 and Part IB Cohort 1	0	1	0	0	0	0	0	0	0
Part 1A Participant Treated in 1A Cohort 4, 1B Cohort 2 and Part 2	0	0	0	1	0	0	0	0	0
Part 1A Participant Treated in 1A Cohort 4 and Part 2	0	0	0	1	0	0	0	0	0
Part 1A Participant Treated in 1A Cohort 5 and 1B Cohort 1	0	0	0	0	1	0	0	0	0
Part 1A Participant Treated in 1A Cohort 5 and 1B Cohort 2	0	0	0	0	1	0	0	0	0
Part 1A COMPLETED	1	1	1	3	3	6	0	0	0
Part 1A NOT COMPLETED	0	0	0	0	0	0	0	0	0
Part 1B STARTED	0	0	0	0	0	0	3	3	0
Part 1B Participant Treated 1B Cohort 1 and Part 2	0	0	0	0	0	0	1	0	0
Part 1B COMPLETED	0	0	0	0	0	0	3	3	0
Part 1B NOT COMPLETED	0	0	0	0	0	0	0	0	0
Part 2 STARTED	0	0	0	0	0	0	0	0	3
Part 2 COMPLETED	0	0	0	0	0	0	0	0	3
Part 2 NOT COMPLETED	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Baseline characteristics are reported separately for each cohort.

Baseline characteristics by cohort

Measure	Part 1A: Cohort 1 n=1 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=1 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 n=1 Participants Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 n=3 Participants Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 n=3 Participants Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 n=6 Participants Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 n=3 Participants Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 n=3 Participants Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 n=3 Participants Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.	Total n=24 Participants Total of all reporting groups
Age, Continuous Part 1A	64.0 years STANDARD_DEVIATION NA • n=1 Participants • Baseline characteristics are reported separately for each cohort.	57.0 years STANDARD_DEVIATION NA • n=1 Participants • Baseline characteristics are reported separately for each cohort.	50.0 years STANDARD_DEVIATION NA • n=1 Participants • Baseline characteristics are reported separately for each cohort.	58.0 years STANDARD_DEVIATION 3.46 • n=3 Participants • Baseline characteristics are reported separately for each cohort.	52.0 years STANDARD_DEVIATION 14.73 • n=3 Participants • Baseline characteristics are reported separately for each cohort.	53.2 years STANDARD_DEVIATION 10.89 • n=6 Participants • Baseline characteristics are reported separately for each cohort.	—	—	—	54.7 years STANDARD_DEVIATION 9.39 • n=15 Participants • Baseline characteristics are reported separately for each cohort.
Age, Continuous Part 1B	—	—	—	—	—	—	59.3 years STANDARD_DEVIATION 5.13 • n=3 Participants • Baseline characteristics are reported separately for each cohort.	52.3 years STANDARD_DEVIATION 13.32 • n=3 Participants • Baseline characteristics are reported separately for each cohort.	—	55.8 years STANDARD_DEVIATION 9.81 • n=6 Participants • Baseline characteristics are reported separately for each cohort.
Age, Continuous Part 2	—	—	—	—	—	—	—	—	57.0 years STANDARD_DEVIATION 3.46 • n=3 Participants • Baseline characteristics are reported separately for each cohort.	57.0 years STANDARD_DEVIATION 3.46 • n=3 Participants • Baseline characteristics are reported separately for each cohort.
Sex: Female, Male Part 1A · Female	1 Participants n=1 Participants • Baseline demographics are presented for each cohort in different rows.	0 Participants n=1 Participants • Baseline demographics are presented for each cohort in different rows.	1 Participants n=1 Participants • Baseline demographics are presented for each cohort in different rows.	2 Participants n=3 Participants • Baseline demographics are presented for each cohort in different rows.	1 Participants n=3 Participants • Baseline demographics are presented for each cohort in different rows.	0 Participants n=6 Participants • Baseline demographics are presented for each cohort in different rows.	—	—	—	5 Participants n=15 Participants • Baseline demographics are presented for each cohort in different rows.
Sex: Female, Male Part 1A · Male	0 Participants n=1 Participants • Baseline demographics are presented for each cohort in different rows.	1 Participants n=1 Participants • Baseline demographics are presented for each cohort in different rows.	0 Participants n=1 Participants • Baseline demographics are presented for each cohort in different rows.	1 Participants n=3 Participants • Baseline demographics are presented for each cohort in different rows.	2 Participants n=3 Participants • Baseline demographics are presented for each cohort in different rows.	6 Participants n=6 Participants • Baseline demographics are presented for each cohort in different rows.	—	—	—	10 Participants n=15 Participants • Baseline demographics are presented for each cohort in different rows.
Sex: Female, Male Part 1B · Female	—	—	—	—	—	—	0 Participants n=3 Participants • Baseline demographics are presented for each cohort in different rows.	1 Participants n=3 Participants • Baseline demographics are presented for each cohort in different rows.	—	1 Participants n=6 Participants • Baseline demographics are presented for each cohort in different rows.
Sex: Female, Male Part 1B · Male	—	—	—	—	—	—	3 Participants n=3 Participants • Baseline demographics are presented for each cohort in different rows.	2 Participants n=3 Participants • Baseline demographics are presented for each cohort in different rows.	—	5 Participants n=6 Participants • Baseline demographics are presented for each cohort in different rows.
Sex: Female, Male Part 2 · Female	—	—	—	—	—	—	—	—	1 Participants n=3 Participants • Baseline demographics are presented for each cohort in different rows.	1 Participants n=3 Participants • Baseline demographics are presented for each cohort in different rows.
Sex: Female, Male Part 2 · Male	—	—	—	—	—	—	—	—	2 Participants n=3 Participants • Baseline demographics are presented for each cohort in different rows.	2 Participants n=3 Participants • Baseline demographics are presented for each cohort in different rows.
Race/Ethnicity, Customized Part 1A : Asian	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	1 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.	—	—	—	1 Participants n=15 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 1B: Asian	—	—	—	—	—	—	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	—	0 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 2: Asian	—	—	—	—	—	—	0 Participants Baseline demographics are reported separately for each cohort.	—	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 1A Black or African American	1 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	1 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	2 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	2 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	2 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.	—	—	—	8 Participants n=15 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 1B Black or African American	—	—	—	—	—	—	1 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	1 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	—	2 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 2: Black or African American	—	—	—	—	—	—	—	—	2 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	2 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 1A: White	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	1 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	1 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	1 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	3 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.	—	—	—	6 Participants n=15 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 1B: White	—	—	—	—	—	—	1 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	1 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	—	2 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 2: White	—	—	—	—	—	—	—	—	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 1A: American Indian or Alaska Native	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.	—	—	—	0 Participants n=15 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 1B: American Indian or Alaska Native	—	—	—	—	—	—	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	1 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	—	1 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 2: American Indian or Alaska Native	—	—	—	—	—	—	—	—	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 1A: Not Reported	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.	—	—	—	0 Participants n=15 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 1B: Not Reported	—	—	—	—	—	—	1 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	—	1 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 2: Not Reported	—	—	—	—	—	—	—	—	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 1A: Other	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.	—	—	—	0 Participants n=15 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 1B: Other	—	—	—	—	—	—	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	—	0 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 2: Other	—	—	—	—	—	—	—	—	1 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	1 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 1A: Hispanic	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	1 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	0 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	2 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.	—	—	—	3 Participants n=15 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 1B: Hispanic	—	—	—	—	—	—	1 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	2 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	—	3 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 2: Hispanic	—	—	—	—	—	—	—	—	2 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	2 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 1A: Not Hispanic	1 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	1 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	1 Participants n=1 Participants • Baseline demographics are reported separately for each cohort.	2 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	3 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	4 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.	—	—	—	12 Participants n=15 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 1B: Not Hispanic	—	—	—	—	—	—	2 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	1 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	—	3 Participants n=6 Participants • Baseline demographics are reported separately for each cohort.
Race/Ethnicity, Customized Part 2: Not Hispanic	—	—	—	—	—	—	—	—	1 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.	1 Participants n=3 Participants • Baseline demographics are reported separately for each cohort.
Region of Enrollment United States	1 participants n=1 Participants • All participants in Part 1A were enrolled in the United States.	1 participants n=1 Participants • All participants in Part 1A were enrolled in the United States.	1 participants n=1 Participants • All participants in Part 1A were enrolled in the United States.	3 participants n=3 Participants • All participants in Part 1A were enrolled in the United States.	3 participants n=3 Participants • All participants in Part 1A were enrolled in the United States.	6 participants n=6 Participants • All participants in Part 1A were enrolled in the United States.	3 participants n=3 Participants • All participants in Part 1B were enrolled in the United States.	3 participants n=3 Participants • All participants in Part 1B were enrolled in the United States.	3 participants n=3 Participants • All participants in Part 2 were enrolled in the United States.	3 participants n=3 Participants • All participants in Part 2 were enrolled in the United States.

PRIMARY outcome

Timeframe: Throughout the study, up to 43 days

Observation of side effects determines the highest safe dose for further study

Outcome measures

Measure	Part 1A: Cohort 1 n=1 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=1 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 n=1 Participants Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 n=3 Participants Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 n=3 Participants Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 n=6 Participants Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Number and Types of Adverse Events (AEs), Including Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 Alone in Part 1A Event leading to MGD020 withdrawal	0 participants with adverse events by type	0 participants with adverse events by type	0 participants with adverse events by type	0 participants with adverse events by type	0 participants with adverse events by type	0 participants with adverse events by type	—	—	—
Number and Types of Adverse Events (AEs), Including Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 Alone in Part 1A Any Adverse Event	1 participants with adverse events by type	1 participants with adverse events by type	1 participants with adverse events by type	3 participants with adverse events by type	1 participants with adverse events by type	5 participants with adverse events by type	—	—	—
Number and Types of Adverse Events (AEs), Including Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 Alone in Part 1A Treatment-related Adverse Event	0 participants with adverse events by type	1 participants with adverse events by type	1 participants with adverse events by type	1 participants with adverse events by type	0 participants with adverse events by type	2 participants with adverse events by type	—	—	—
Number and Types of Adverse Events (AEs), Including Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 Alone in Part 1A Severe adverse event	0 participants with adverse events by type	0 participants with adverse events by type	0 participants with adverse events by type	0 participants with adverse events by type	0 participants with adverse events by type	0 participants with adverse events by type	—	—	—
Number and Types of Adverse Events (AEs), Including Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 Alone in Part 1A Treatment-related severe adverse event	0 participants with adverse events by type	0 participants with adverse events by type	0 participants with adverse events by type	0 participants with adverse events by type	0 participants with adverse events by type	0 participants with adverse events by type	—	—	—

PRIMARY outcome

Timeframe: Throughout the study, up to 43 days

Observation of side effects determines the highest safe dose for further study

Outcome measures

Measure	Part 1A: Cohort 1 n=3 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=3 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 1B. Any AE	2 participants with AE by type	1 participants with AE by type	—	—	—	—	—	—	—
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 1B. Treatment-related AE	2 participants with AE by type	0 participants with AE by type	—	—	—	—	—	—	—
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 1B. Severe AE	1 participants with AE by type	0 participants with AE by type	—	—	—	—	—	—	—
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 1B. Severe treatment-related AE	0 participants with AE by type	0 participants with AE by type	—	—	—	—	—	—	—
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 1B. Event leading to MGD020 withdrawal	0 participants with AE by type	0 participants with AE by type	—	—	—	—	—	—	—
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 1B. Event leading to MGD014 withdrawal	0 participants with AE by type	0 participants with AE by type	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Throughout the study, up to 81 days.

Observation of side effects determines the highest safe dose for further study

Outcome measures

Measure	Part 1A: Cohort 1 n=3 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 2. Any AE	2 participants with AE by type	—	—	—	—	—	—	—	—
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 2. Treatment-related AE	0 participants with AE by type	—	—	—	—	—	—	—	—
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 2. Severe AE	0 participants with AE by type	—	—	—	—	—	—	—	—
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 2. Severe treatment-related AE	0 participants with AE by type	—	—	—	—	—	—	—	—
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 2. Event leading to MGD020 withdrawal	0 participants with AE by type	—	—	—	—	—	—	—	—
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 2. Event leading to MGD014 withdrawal	0 participants with AE by type	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2

Population: All participants who received ay least a single-dose of MGD020, and had at least 1 measurable concentration above the lower limit of quantification (LLOQ). One participant in Part A, cohort 4 was excluded from the analysis due to no measurable concentration above the LLOQ. Mean Cmax for Part 2 is after the third infusion.

The highest concentration of MGD020 at the end of the infusion

Outcome measures

Measure	Part 1A: Cohort 1 n=1 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=1 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 n=1 Participants Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 n=2 Participants Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 n=3 Participants Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 n=6 Participants Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 n=3 Participants Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 n=3 Participants Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 n=3 Participants Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Mean Maximum Concentration of MGD020	54.2 mcg/liter Confidence interval cannot be calculated for a cohort = 1.	45.8 mcg/liter Confidence interval cannot be calculated for a cohort = 1.	185.0 mcg/liter Confidence interval cannot be calculated for a cohort = 1.	540.5 mcg/liter Interval 441.5 to 639.5	2000 mcg/liter Interval 1807.0 to 2193.0	6415 mcg/liter Interval 5729.0 to 7101.0	3410 mcg/liter Interval 350.5 to 6469.0	6947 mcg/liter Interval 5078.0 to 8816.0	8593 mcg/liter Interval 7883.0 to 9303.0

SECONDARY outcome

Timeframe: Throughout the study, up to 43 days for Part 1B, and up to 78 days for Part 2

Population: All participants who received at least a single-dose of MGD014, and had at least 1 measurable concentration above the LLOQ. Mean Cmax for Part 2 is after the third infusion.

The highest concentration of MGD014 at the end of the infusion (Cmax).

Outcome measures

Measure	Part 1A: Cohort 1 n=3 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=3 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 n=3 Participants Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Mean Maximum Concentration of MGD014	6070 mcg/liter Interval 4325.0 to 7815.0	6297 mcg/liter Interval 5213.0 to 7380.0	7043 mcg/liter Interval 6694.0 to 7393.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2

Population: All participants who received at least a single-dose of MGD020, and had at least 1 measurable concentration above the LLOQ. One participant in Part A, cohort 4 was excluded from the analysis due to no measurable concentration above the LLOQ.. Mean Tmax for Part 2 is after the first infusion.

The amount of time required to get maximum concentration of MGD020

Outcome measures

Measure	Part 1A: Cohort 1 n=1 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=1 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 n=1 Participants Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 n=2 Participants Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 n=3 Participants Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 n=6 Participants Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 n=3 Participants Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 n=3 Participants Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 n=3 Participants Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Mean Time to Maximal Concentration of MGD020	1.4 hours Full range is not applicable to a cohort of 1.	2.1 hours Full range is not applicable to a cohort of 1.	2.1 hours Full range is not applicable to a cohort of 1.	1.6 hours Interval 1.1 to 2.0	1.4 hours Interval 1.1 to 2.0	2.1 hours Interval 1.1 to 5.0	3.8 hours Interval 1.1 to 6.6	1.2 hours Interval 1.0 to 1.4	1.0 hours Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: Throughout the study, up to 43 days for Part 1B, and up to 78 days for Part 2

Population: All participants who received at least a single-dose of MGD014, and had at least 1 measurable concentration above the LLOQ. Mean Tmax for Part 2 is after the first infusion.

The amount of time required to get maximum concentration of MGD014

Outcome measures

Measure	Part 1A: Cohort 1 n=3 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=3 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 n=3 Participants Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Mean Time to Maximal Concentration of MGD014	2.7 hours Interval 1.1 to 5.1	1.7 hours Interval 1.0 to 2.1	1.3 hours Interval 1.0 to 2.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2

Population: All participants who received at least a single-dose of MGD020, and had at least 1 measurable concentration above the LLOQ. One participant in Part A, cohort 4 was excluded from the analysis due to no measurable concentration above the LLOQ. Mean AUC for Part 2 is after the first infusion.

Total body exposure to MGD020

Outcome measures

Measure	Part 1A: Cohort 1 n=1 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=1 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 n=1 Participants Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 n=2 Participants Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 n=3 Participants Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 n=6 Participants Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 n=3 Participants Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 n=3 Participants Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 n=3 Participants Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Mean Area Under the Concentration-time Curve (AUC) of MGD020	5570 mcg*hour/liter CI cannot be calculated for cohort = 1.	9280 mcg*hour/liter CI cannot be calculated for cohort = 1.	29400 mcg*hour/liter CI cannot be calculated for cohort = 1.	88900 mcg*hour/liter Interval 63224.0 to 114576.0	283667 mcg*hour/liter Interval 213313.0 to 354021.0	957833 mcg*hour/liter Interval 804523.0 to 1111143.0	365667 mcg*hour/liter Interval 311299.0 to 420035.0	1088333 mcg*hour/liter Interval 790851.0 to 1385815.0	854333 mcg*hour/liter Interval 771129.0 to 937538.0

SECONDARY outcome

Timeframe: Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2

Population: All participants who received at least a single-dose of MGD014, and had at least 1 measurable concentration above the LLOQ. Mean AUC for Part 2 is after the first infusion.

Total body exposure to MGD014

Outcome measures

Measure	Part 1A: Cohort 1 n=3 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=3 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 n=3 Participants Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Mean AUC of MGD014	572333 mcg*hour/liter Interval 516478.0 to 628189.0	631000 mcg*hour/liter Interval 458086.0 to 803914.0	581333 mcg*hour/liter Interval 511390.0 to 651276.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2

Population: All participants who received at least a single-dose of MGD020, and had at least 1 measurable concentration above the LLOQ. One participant in Part A, cohort 4 was excluded from the analysis due to no measurable concentration above the LLOQ.. Mean half-life for Part 2 is after the third infusion.

The amount of time needed for the body to clear half of the dose of MGD020

Outcome measures

Measure	Part 1A: Cohort 1 n=1 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=1 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 n=1 Participants Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 n=2 Participants Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 n=3 Participants Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 n=6 Participants Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 n=3 Participants Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 n=3 Participants Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 n=3 Participants Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Mean Half-life of MGD020	202 hours CI cannot be calculated for a cohort of 1.	462 hours CI cannot be calculated for a cohort of 1.	209 hours CI cannot be calculated for a cohort of 1.	309 hours Interval 219.0 to 398.0	323 hours Interval 229.0 to 418.0	221 hours Interval 94.0 to 348.0	353 hours Interval 238.0 to 468.0	361 hours Interval 322.0 to 401.0	452 hours Interval 430.0 to 475.0

SECONDARY outcome

Timeframe: Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2

Population: All participants who received at least a single-dose of MGD014, and had at least 1 measurable concentration above the LLOQ. Mean AUC for Part 2 is after the third infusion.

The amount of time needed for the body to clear half of the dose of MGD014

Outcome measures

Measure	Part 1A: Cohort 1 n=3 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=3 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 n=3 Participants Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Mean Half-life of MGD014	273 hours Interval 179.0 to 368.0	296 hours Interval 287.0 to 314.0	339 hours Interval 325.0 to 353.0	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Throughout the study, up to 78 days for Part 2

Population: Only participants who received at least 3 doses of MGD020 can be evaluated for Vss. All other cohorts receive only 1 dose, so Vss cannot be calculated in Parts 1A and 1B. Vss is reported only for Part 2 after the third dose of MGD020.

This parameter measures how much of the drug remains in the bloodstream or is distributed to body tissues.

Outcome measures

Measure	Part 1A: Cohort 1 Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 n=3 Participants Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Mean Volume of Distribution at Steady State (Vss) of MGD020	—	—	—	—	—	—	—	—	4.0 liters Interval 3.5 to 4.6

SECONDARY outcome

Timeframe: Throughout the study, up to 78 days for Part 2

Population: Only participants who received at least 3 doses of MGD014 can be evaluated for Vss. All other cohorts receive only 1 dose, so Vss cannot be calculated in Parts 1A and 1B. Vss is reported only in Part 2 after the third dose of MGD014.

This parameter measures how much of the drug remains in the bloodstream or is distributed to body tissues.

Outcome measures

Measure	Part 1A: Cohort 1 Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 n=3 Participants Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Mean Volume of Distribution at Steady State of MGD014	—	—	—	—	—	—	—	—	3.5 liters Interval 2.8 to 4.2

SECONDARY outcome

Timeframe: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2

Population: All participants who received at least a single-dose of MGD020, and had at least 1 measurable concentration above the LLOQ. One participant in Part A, cohort 4 was excluded from analysis due to no measurable concentration above the LLOQ.

Total body clearance of the drug from plasma of MGD020

Outcome measures

Measure	Part 1A: Cohort 1 n=1 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=1 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 n=1 Participants Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 n=2 Participants Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 n=3 Participants Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 n=6 Participants Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 n=3 Participants Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 n=3 Participants Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 n=3 Participants Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Mean Clearance of MGD020	0.02 liters CI cannot be calculated for a cohort of 1.	0.03 liters CI cannot be calculated for a cohort of 1.	0.04 liters CI cannot be calculated for a cohort of 1.	0.03 liters Interval 0.02 to 0.04	0.034 liters Interval 0.034 to 0.035	0.03 liters Interval 0.02 to 0.03	0.03 liters Interval 0.02 to 0.03	0.02 liters Interval 0.01 to 0.03	0.012 liters Interval 0.011 to 0.013

SECONDARY outcome

Timeframe: Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2

Population: All participants who received at least one dose of MGD014. Clearance for Part 2 is reported after the third dose of MGD014.

Total body clearance of the drug from plasma of MGD014

Outcome measures

Measure	Part 1A: Cohort 1 n=3 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=3 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 n=3 Participants Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Mean Clearance of MGD014	0.02 liters Interval 0.01 to 0.02	0.04 liters Interval 0.02 to 0.05	0.02 liters Interval 0.015 to 0.02	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2.

Population: All participants who received at least one dose of assigned study treatment.

Outcome measures

Measure	Part 1A: Cohort 1 n=1 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=1 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 n=1 Participants Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 n=3 Participants Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 n=3 Participants Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 n=6 Participants Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 n=3 Participants Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 n=3 Participants Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 n=3 Participants Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Number of Participants With Elevations in Serum Cytokine Levels of IFN-γ, IL-2, IL-5, IL-6, IL-10, or TNF-α No elevation of serum cytokine levels	1 Participants	1 Participants	1 Participants	3 Participants	3 Participants	3 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Elevations in Serum Cytokine Levels of IFN-γ, IL-2, IL-5, IL-6, IL-10, or TNF-α Elevation of at least 1 serum cytokine level.	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	2 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2

Population: All participants who received at least one dose of assigned study treatment.

Number of patients who develop antibodies against MDG020

Outcome measures

Measure	Part 1A: Cohort 1 n=1 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=1 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 n=1 Participants Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 n=3 Participants Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 n=3 Participants Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 n=6 Participants Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 n=3 Participants Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 n=3 Participants Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 n=3 Participants Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Anti-drug Antibody Formation to MGD020 Negative before treatment and negative after treatment	1 Participants	0 Participants	1 Participants	3 Participants	3 Participants	4 Participants	3 Participants	3 Participants	3 Participants
Anti-drug Antibody Formation to MGD020 Negative before treatment and positive at least once after treatment	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Anti-drug Antibody Formation to MGD020 Positive before treatment and positive after treatment	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2

Population: All participants who received at least 1 dose of MGD014. Participants in Part 1A did not receive MGD014.

Number of patients who develop antibodies against MDG014

Outcome measures

Measure	Part 1A: Cohort 1 n=3 Participants Single dose: 1 mcg/kg MGD020 administered IV	Part 1A: Cohort 2 n=3 Participants Single dose: 3 mcg/kg MGD020 administered IV	Part 1A: Cohort 3 n=3 Participants Single dose: 10 mcg/kg MGD020 administered IV	Part 1A: Cohort 4 Single dose: 30 mcg/kg MGD020 administered IV	Part 1A: Cohort 5 Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 Single dose: 300 mcg/kg MGD020 administered IV	Part 1B: Cohort 1 Single dose: 100 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 Single dose: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV.	Part 2 Three doses: 300 mcg/kg MGD020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Anti-drug Antibody Formation to MGD014 Negative before treatment, and positive at least once after treatment	0 Participants	0 Participants	0 Participants	—	—	—	—	—	—
Anti-drug Antibody Formation to MGD014 Negative before treatment, and negative after treatment	3 Participants	3 Participants	3 Participants	—	—	—	—	—	—

Adverse Events

Part 1A: Cohort 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1A: Cohort 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1A: Cohort 3

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1A: Cohort 4

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 1A: Cohort 5

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1A: Cohort 6

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1B: Cohort 1

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1B: Cohort 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Part 1A: Cohort 1 n=1 participants at risk Single dose: 1 mcg/kg MGD-020 administered IV	Part 1A: Cohort 2 n=1 participants at risk Single dose: 3 mcg/kg MGD-020 administered IV	Part 1A: Cohort 3 n=1 participants at risk Single dose: 10 mcg/kg MGD-020 administered IV	Part 1A: Cohort 4 n=3 participants at risk Single dose: 30 mcg/kg MGD-020 administered IV	Part 1A: Cohort 5 n=3 participants at risk Single dose: 100 mcg/kg MGD020 administered IV	Part 1A: Cohort 6 n=6 participants at risk Single dose: 300 mcg/kg MGD-020 administered IV	Part 1B: Cohort 1 n=3 participants at risk Single dose: 100 mcg/kg MGD-020 + 300 mcg/kg MGD014 administered IV.	Part 1B: Cohort 2 n=3 participants at risk Single dose: 300 mcg/kg MGD-020 + 300 mcg/kg MGD014 administered IV.	Part 2 n=3 participants at risk Three doses: 300 mcg/kg MGD-020 + 300 mcg/kg MGD014 administered IV once every 2 weeks for 4 weeks.
Cardiac disorders Tachycardia	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Eye disorders Vision blurred	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Eye disorders Visual field defect	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Gastrointestinal disorders Diarrhoea	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Gastrointestinal disorders Dry mouth	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Gastrointestinal disorders Gingival pain	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Gastrointestinal disorders Lip dry	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Gastrointestinal disorders Tongue coated	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Gastrointestinal disorders Vomiting	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
General disorders Chills	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
General disorders Fatigue	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 2/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
General disorders Feeling abnormal	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	100.0% 1/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
General disorders Injection site pain	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	100.0% 1/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
General disorders Swelling face	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
General disorders Vessel puncture site bruise	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Immune system disorders Seasonal allergy	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Infections and infestations Bronchitis	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Infections and infestations Pustule	100.0% 1/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Injury, poisoning and procedural complications Vascular access site vesicles	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Investigations Blood pressure increased	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	100.0% 1/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Investigations Glomerular filtration rate decreased	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Investigations Alanine aminotransferase increased	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Investigations Bilirubin conjugated increased	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Investigations Blood bilirubin increased	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Investigations Blood phosphorus decreased	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Investigations Carbon dioxide decreased	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Investigations Urine output decreased	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	100.0% 1/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	100.0% 1/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	100.0% 1/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Nervous system disorders Headache	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	100.0% 1/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 2/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Nervous system disorders Brain fog	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Nervous system disorders Head discomfort	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	100.0% 1/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Psychiatric disorders Panic attack	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Skin and subcutaneous tissue disorders Skin burning sensation	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	16.7% 1/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.
Vascular disorders Hypotension	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/1 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	33.3% 1/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/6 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.	0.00% 0/3 • The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.

Additional Information

Chief Medical Officer

MacroGenics, Inc.

Phone: 301-251-5172

Email: info@macrogenics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60