Trial Outcomes & Findings for A Study of TAK-510 in Healthy Adults (NCT NCT04731922)

NCT ID: NCT04731922

Last Updated: 2024-03-04

Results Overview

Vital signs included systolic and diastolic blood pressure, body temperature, pulse rate (PR), respiratory rate, orthostatic blood pressure and pulse rate assessments. The markedly abnormal value (MAV) criteria for vital signs were systolic blood pressure (SBP) less than (\<) 85 millimeter of mercury (mmHg), greater than (\>) 180 mmHg; diastolic blood pressure (DBP) \<50 mmHg, \>110 mmHg; body temperature \<35.6 degree Celsius, \>37.7 degree Celsius; PR \<50 beats per minute (bpm), \>120 bpm; respiratory rate \<12 breaths per minute (breaths/minute), \>16 breaths/minute; orthostatic hypotension decrease in SBP greater than or equal to (\>=) 20 mmHg or a decrease in DBP \>=10 mmHg on standing; orthostatic tachycardia defined as an increase of \>30 bpm or heart rate (HR) \>120 bpm on standing. Number of participants who met the MAV criteria for vital signs at least once post dose were reported.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

124 participants

Primary outcome timeframe

Parts 1 and 2: From the first dose of study drug up to Day 29

Results posted on

2024-03-04

Participant Flow

Participants took part in the study at 2 investigative sites in the United States from 3 February 2021 to 24 July 2022.

Healthy participants were enrolled in study into 2 Parts: Single Rising Doses (SRD) (Part 1) and Multiple Rising Doses (MRD) (Part 2) to receive TAK-510 placebo-matching or TAK-510 injection. Starting Dose 1 was 5 micrograms (mcg) and subsequent doses were increased from low dose to high dose for Doses 1-11 and Doses 1A-4A in Part 1 or Part 2, respectively. Study was completed after completion of Parts 1 and 2. Sponsor decided not to conduct Part 3 after comprehensive review of available data.

Participant milestones

Participant milestones
Measure	Part 1, SRD Cohorts 1 to 11: Pooled Placebo TAK-510 placebo-matching injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 1: TAK-510 Dose 1 TAK-510 Dose 1, injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 2: TAK-510 Dose 2 TAK-510 Dose 2, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available pharmacokinetic (PK) data from previous SRD Cohort 1.	Part 1, SRD Cohort 3: TAK-510 Dose 3 TAK-510 Dose 3, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 4: TAK-510 Dose 4 TAK-510 Dose 4, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 5: TAK-510 Dose 5 TAK-510 Dose 5, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 6: TAK-510 Dose 6 TAK-510 Dose 6, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 7: TAK-510 Dose 7 TAK-510 Dose 7, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 8: TAK-510 Dose 8 TAK-510 Dose 8, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 9: TAK-510 Dose 9 TAK-510 Dose 9, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 10: TAK-510 Dose 10 TAK-510 Dose 10, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 11: TAK-510 Dose 11 TAK-510 Dose 11, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 2, MRD 12 to 15 Cohorts: Pooled Placebo TAK-510 placebo-matching placebo, injection, subcutaneously from Days 1 to 5.	Part 2, MRD Cohort 12: Dose 1A TAK-510 Dose 1A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from SRD Part 1.	Part 2, MRD Cohort 13: Dose 2A TAK-510 Dose 2A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and available PK data from previous MRD Cohort.	Part 2, MRD Cohort 14: Dose 3A TAK-510 Dose 3A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.	Part 2, MRD Cohort 15: Dose 4A TAK-510 Dose 4A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.
Overall Study STARTED	23	6	6	6	7	6	6	6	6	6	6	6	8	8	6	6	6
Overall Study COMPLETED	22	6	6	5	6	5	4	6	6	6	5	6	8	7	6	6	6
Overall Study NOT COMPLETED	1	0	0	1	1	1	2	0	0	0	1	0	0	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1, SRD Cohorts 1 to 11: Pooled Placebo TAK-510 placebo-matching injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 3: TAK-510 Dose 3 TAK-510 Dose 3, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 4: TAK-510 Dose 4 TAK-510 Dose 4, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 5: TAK-510 Dose 5 TAK-510 Dose 5, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 6: TAK-510 Dose 6 TAK-510 Dose 6, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 10: TAK-510 Dose 10 TAK-510 Dose 10, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 2, MRD Cohort 12: Dose 1A TAK-510 Dose 1A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from SRD Part 1.
Overall Study Adverse Event	0	0	0	0	0	1	0
Overall Study Lost to Follow-up	0	1	0	1	0	0	0
Overall Study Withdrawal by Subject	1	0	1	0	1	0	1
Overall Study Other	0	0	0	0	1	0	0

Baseline Characteristics

A Study of TAK-510 in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1, SRD Cohorts 1 to 11: Pooled Placebo n=23 Participants TAK-510 placebo-matching injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 1: TAK-510 Dose 1 n=6 Participants TAK-510 Dose 1, injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 2: TAK-510 Dose 2 n=6 Participants TAK-510 Dose 2, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort 1.	Part 1, SRD Cohort 3: TAK-510 Dose 3 n=6 Participants TAK-510 Dose 3, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 4: TAK-510 Dose 4 n=7 Participants TAK-510 Dose 4, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 5: TAK-510 Dose 5 n=6 Participants TAK-510 Dose 5, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 6: TAK-510 Dose 6 n=6 Participants TAK-510 Dose 6, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 7: TAK-510 Dose 7 n=6 Participants TAK-510 Dose 7, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 8: TAK-510 Dose 8 n=6 Participants TAK-510 Dose 8, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 9: TAK-510 Dose 9 n=6 Participants TAK-510 Dose 9, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 10: TAK-510 Dose 10 n=6 Participants TAK-510 Dose 10, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 11: TAK-510 Dose 11 n=6 Participants TAK-510 Dose 11, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 2, MRD 12 to 15 Cohorts: Pooled Placebo n=8 Participants TAK-510 placebo-matching placebo, injection, subcutaneously from Days 1 to 5.	Part 2, MRD Cohort 12: Dose 1A n=8 Participants TAK-510 Dose 1A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from SRD Part 1.	Part 2, MRD Cohort 13: Dose 2A n=6 Participants TAK-510 Dose 2A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and available PK data from previous MRD Cohort.	Part 2, MRD Cohort 14: Dose 3A n=6 Participants TAK-510 Dose 3A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.	Part 2, MRD Cohort 15: Dose 4A n=6 Participants TAK-510 Dose 4A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.	Total n=124 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=64 Participants	6 Participants n=17 Participants	6 Participants n=21 Participants	8 Participants n=22 Participants	8 Participants n=8 Participants	6 Participants n=16 Participants	6 Participants n=135 Participants	6 Participants n=136 Participants	124 Participants n=44 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants	0 Participants n=17 Participants	1 Participants n=21 Participants	0 Participants n=22 Participants	2 Participants n=8 Participants	0 Participants n=16 Participants	1 Participants n=135 Participants	0 Participants n=136 Participants	17 Participants n=44 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	5 Participants n=10 Participants	5 Participants n=115 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	5 Participants n=64 Participants	6 Participants n=17 Participants	5 Participants n=21 Participants	8 Participants n=22 Participants	6 Participants n=8 Participants	6 Participants n=16 Participants	5 Participants n=135 Participants	6 Participants n=136 Participants	107 Participants n=44 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	4 Participants n=6 Participants	3 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	3 Participants n=21 Participants	4 Participants n=22 Participants	3 Participants n=8 Participants	1 Participants n=16 Participants	1 Participants n=135 Participants	1 Participants n=136 Participants	34 Participants n=44 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=10 Participants	5 Participants n=115 Participants	2 Participants n=6 Participants	3 Participants n=6 Participants	6 Participants n=64 Participants	6 Participants n=17 Participants	3 Participants n=21 Participants	4 Participants n=22 Participants	5 Participants n=8 Participants	5 Participants n=16 Participants	5 Participants n=135 Participants	5 Participants n=136 Participants	90 Participants n=44 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=64 Participants	2 Participants n=17 Participants	0 Participants n=21 Participants	1 Participants n=22 Participants	1 Participants n=8 Participants	1 Participants n=16 Participants	2 Participants n=135 Participants	1 Participants n=136 Participants	16 Participants n=44 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	2 Participants n=44 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants	1 Participants n=6 Participants	3 Participants n=6 Participants	3 Participants n=64 Participants	0 Participants n=17 Participants	3 Participants n=21 Participants	2 Participants n=22 Participants	2 Participants n=8 Participants	4 Participants n=16 Participants	3 Participants n=135 Participants	3 Participants n=136 Participants	48 Participants n=44 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	1 Participants n=115 Participants	4 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=64 Participants	4 Participants n=17 Participants	3 Participants n=21 Participants	4 Participants n=22 Participants	5 Participants n=8 Participants	1 Participants n=16 Participants	1 Participants n=135 Participants	2 Participants n=136 Participants	51 Participants n=44 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	1 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	7 Participants n=44 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants
Region of Enrollment United States	23 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	6 Participants n=10 Participants	6 Participants n=115 Participants	6 Participants n=6 Participants	6 Participants n=6 Participants	6 Participants n=64 Participants	6 Participants n=17 Participants	6 Participants n=21 Participants	8 Participants n=22 Participants	8 Participants n=8 Participants	6 Participants n=16 Participants	6 Participants n=135 Participants	6 Participants n=136 Participants	124 Participants n=44 Participants

PRIMARY outcome

Timeframe: Parts 1 and 2: From the first dose of study drug up to Day 29

Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study treatment.

Outcome measures

Outcome measures
Measure	Part 1, SRD Cohorts 1 to 11: Pooled Placebo n=23 Participants TAK-510 placebo-matching injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 1: TAK-510 Dose 1 n=6 Participants TAK-510 Dose 1, injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 2: TAK-510 Dose 2 n=6 Participants TAK-510 Dose 2, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort 1.	Part 1, SRD Cohort 3: TAK-510 Dose 3 n=6 Participants TAK-510 Dose 3, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 4: TAK-510 Dose 4 n=7 Participants TAK-510 Dose 4, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 5: TAK-510 Dose 5 n=6 Participants TAK-510 Dose 5, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 6: TAK-510 Dose 6 n=6 Participants TAK-510 Dose 6, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 7: TAK-510 Dose 7 n=6 Participants TAK-510 Dose 7, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 8: TAK-510 Dose 8 n=6 Participants TAK-510 Dose 8, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 9: TAK-510 Dose 9 n=6 Participants TAK-510 Dose 9, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 10: TAK-510 Dose 10 n=6 Participants TAK-510 Dose 10, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 11: TAK-510 Dose 11 n=6 Participants TAK-510 Dose 11, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 2, MRD 12 to 15 Cohorts: Pooled Placebo n=8 Participants TAK-510 placebo-matching placebo, injection, subcutaneously from Days 1 to 5.	Part 2, MRD Cohort 12: Dose 1A n=8 Participants TAK-510 Dose 1A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from SRD Part 1.	Part 2, MRD Cohort 13: Dose 2A n=6 Participants TAK-510 Dose 2A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and available PK data from previous MRD Cohort.	Part 2, MRD Cohort 14: Dose 3A n=6 Participants TAK-510 Dose 3A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.	Part 2, MRD Cohort 15: Dose 4A n=6 Participants TAK-510 Dose 4A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose SBP, Standing: >180 mmHg	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose PR, Standing: >120 bpm	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	4 Participants	2 Participants	2 Participants	5 Participants	4 Participants	5 Participants	2 Participants	1 Participants	4 Participants	1 Participants	4 Participants	4 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose Orthostatic DBP: Decrease in DBP >=10 mmHg on standing	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose PR, Standing: <50 bpm	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose SBP, Semi-Recumbent: <85 mmHg	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose SBP, Semi-Recumbent: >180 mmHg	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose DBP, Semi-Recumbent: <50 mmHg	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose DBP, Semi-Recumbent: >110 mmHg	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose PR, Semi-Recumbent: <50 bpm	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose PR, Semi-Recumbent: >120 bpm	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose Respiratory Rate, Semi-Recumbent: <12 breaths/minute	3 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	4 Participants	4 Participants	5 Participants	0 Participants	1 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose Respiratory Rate, Semi-Recumbent: >16 breaths/minute	10 Participants	4 Participants	3 Participants	3 Participants	2 Participants	3 Participants	5 Participants	1 Participants	3 Participants	3 Participants	3 Participants	2 Participants	6 Participants	4 Participants	4 Participants	5 Participants	5 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose Orthostatic SBP: Decrease in SBP >=20 mmHg on standing	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	3 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose Orthostatic PR: Increase of >30 or HR >120 mmHg on standing	6 Participants	0 Participants	3 Participants	3 Participants	3 Participants	5 Participants	2 Participants	4 Participants	6 Participants	4 Participants	6 Participants	2 Participants	4 Participants	6 Participants	3 Participants	6 Participants	5 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose Temperature, <35.6 Degree Celsius	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose Temperature, >37.7 Degree Celsius	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose SBP, Standing: <85 mmHg	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose DBP, Standing: <50 mmHg	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	3 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose DBP, Standing: >110 mmHg	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Parts 1 and 2: From the first dose of study drug up to Day 29

Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study treatment.

ECG included HR, PR, QT interval with Fridericia correction (QTcF) interval and QRS duration. The MAV criteria for 12-lead ECG parameters included heart rate \<50 bpm, \>120 bpm; PR interval less than or equal to (\<=)80 milliseconds (msec), \>=200 msec; QTcF interval \>=500 msec; QRS duration \<=80 msec, \>=120 msec. Number of participants who met the MAV criteria for ECG parameters at least once post dose were reported.

Outcome measures

Outcome measures
Measure	Part 1, SRD Cohorts 1 to 11: Pooled Placebo n=23 Participants TAK-510 placebo-matching injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 1: TAK-510 Dose 1 n=6 Participants TAK-510 Dose 1, injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 2: TAK-510 Dose 2 n=6 Participants TAK-510 Dose 2, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort 1.	Part 1, SRD Cohort 3: TAK-510 Dose 3 n=6 Participants TAK-510 Dose 3, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 4: TAK-510 Dose 4 n=7 Participants TAK-510 Dose 4, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 5: TAK-510 Dose 5 n=6 Participants TAK-510 Dose 5, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 6: TAK-510 Dose 6 n=6 Participants TAK-510 Dose 6, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 7: TAK-510 Dose 7 n=6 Participants TAK-510 Dose 7, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 8: TAK-510 Dose 8 n=6 Participants TAK-510 Dose 8, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 9: TAK-510 Dose 9 n=6 Participants TAK-510 Dose 9, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 10: TAK-510 Dose 10 n=6 Participants TAK-510 Dose 10, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 11: TAK-510 Dose 11 n=6 Participants TAK-510 Dose 11, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 2, MRD 12 to 15 Cohorts: Pooled Placebo n=8 Participants TAK-510 placebo-matching placebo, injection, subcutaneously from Days 1 to 5.	Part 2, MRD Cohort 12: Dose 1A n=8 Participants TAK-510 Dose 1A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from SRD Part 1.	Part 2, MRD Cohort 13: Dose 2A n=6 Participants TAK-510 Dose 2A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and available PK data from previous MRD Cohort.	Part 2, MRD Cohort 14: Dose 3A n=6 Participants TAK-510 Dose 3A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.	Part 2, MRD Cohort 15: Dose 4A n=6 Participants TAK-510 Dose 4A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose QTcF Interval, >=500 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose ECG HR, <50 bpm	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose ECG HR, >120 bpm	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose PR Interval, <=80 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose PR Interval, >=200 msec	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose QRS Duration, <=80 msec	2 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose QRS Duration, >=120 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Parts 1 and 2: From the first dose of study drug up to Day 29

Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study treatment. Here, LLN = lower limit of normal; RBC = red blood cell; WBC = white blood cell; ALP = alkaline phosphatase; GGT = Gamma-glutamyl transferase; g/L = gram per liter; mmol/L = millimoles per liter; mg/dL = milligrams per deciliter.

Clinical laboratory parameters included tests for chemistry and hematology. The MAV criteria for laboratory value included hemoglobin \<0.8\*LLN,\>1.2\*ULN; hematocrit \<0.8\*LLN,\>1.2\*ULN;RBC count \<0.8\*LLN, \>1.2\*ULN;WBC count \<0.5\*LLN, \>1.5\*ULN; platelet count \<75\*10\^9 per liter, \>600\*10\^9 per liter; ALT \>3\*ULN; AST \>3\*ULN,GGT \>3\*ULN, normal baseline; \>2\*baseline,abnormal baseline; ALP\>3\*ULN, normal baseline; \>2\*baseline, abnormal baseline; total bilirubin \>1.5\*ULN, normal baseline; \>1.5\* baseline, abnormal baseline; albumin \<25g/L; total protein \<0.8\* LLN, \>1.2\*ULN; creatinine \>177 micromole per liter; blood urea nitrogen \>10.7 mmol/L; sodium \<130 mmol/L, \>150mmol/L; potassium \<3.0mmol/L, \>5.5 mmol/L; glucose \<3mmol/L, \>10mmol/L; chloride \<75mmol/L, \>126mmol/L; calcium corrected serum calcium of \<LLN-8.0 mg/dL; \<LLN-2.0mmol/L; ionized calcium \<LLN-1.0mmol/L; bicarbonate \<8.0mmol/L. Number of participants who met the MAV criteria for laboratory value at least once post dose were reported.

Outcome measures

Outcome measures
Measure	Part 1, SRD Cohorts 1 to 11: Pooled Placebo n=23 Participants TAK-510 placebo-matching injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 1: TAK-510 Dose 1 n=6 Participants TAK-510 Dose 1, injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 2: TAK-510 Dose 2 n=6 Participants TAK-510 Dose 2, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort 1.	Part 1, SRD Cohort 3: TAK-510 Dose 3 n=7 Participants TAK-510 Dose 3, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 4: TAK-510 Dose 4 n=6 Participants TAK-510 Dose 4, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 5: TAK-510 Dose 5 n=6 Participants TAK-510 Dose 5, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 6: TAK-510 Dose 6 n=6 Participants TAK-510 Dose 6, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 7: TAK-510 Dose 7 n=6 Participants TAK-510 Dose 7, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 8: TAK-510 Dose 8 n=6 Participants TAK-510 Dose 8, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 9: TAK-510 Dose 9 n=6 Participants TAK-510 Dose 9, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 10: TAK-510 Dose 10 n=6 Participants TAK-510 Dose 10, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 11: TAK-510 Dose 11 n=6 Participants TAK-510 Dose 11, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 2, MRD 12 to 15 Cohorts: Pooled Placebo n=8 Participants TAK-510 placebo-matching placebo, injection, subcutaneously from Days 1 to 5.	Part 2, MRD Cohort 12: Dose 1A n=8 Participants TAK-510 Dose 1A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from SRD Part 1.	Part 2, MRD Cohort 13: Dose 2A n=6 Participants TAK-510 Dose 2A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and available PK data from previous MRD Cohort.	Part 2, MRD Cohort 14: Dose 3A n=6 Participants TAK-510 Dose 3A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.	Part 2, MRD Cohort 15: Dose 4A n=6 Participants TAK-510 Dose 4A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN)	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug until 30 days after last dose in Parts 1 and 2 (SRD Cohorts: up to Day 31, MRD Cohorts: up to Day 35)

Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study treatment.

A TEAE was defined as an adverse event (AE) that started or worsened after first dose of the study treatment and within 30 days of last dose of study treatment. An AE was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it did not necessarily had to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it was considered related to the drug.

Outcome measures

Outcome measures
Measure	Part 1, SRD Cohorts 1 to 11: Pooled Placebo n=23 Participants TAK-510 placebo-matching injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 1: TAK-510 Dose 1 n=6 Participants TAK-510 Dose 1, injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 2: TAK-510 Dose 2 n=6 Participants TAK-510 Dose 2, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort 1.	Part 1, SRD Cohort 3: TAK-510 Dose 3 n=6 Participants TAK-510 Dose 3, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 4: TAK-510 Dose 4 n=7 Participants TAK-510 Dose 4, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 5: TAK-510 Dose 5 n=6 Participants TAK-510 Dose 5, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 6: TAK-510 Dose 6 n=6 Participants TAK-510 Dose 6, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 7: TAK-510 Dose 7 n=6 Participants TAK-510 Dose 7, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 8: TAK-510 Dose 8 n=6 Participants TAK-510 Dose 8, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 9: TAK-510 Dose 9 n=6 Participants TAK-510 Dose 9, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 10: TAK-510 Dose 10 n=6 Participants TAK-510 Dose 10, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 11: TAK-510 Dose 11 n=6 Participants TAK-510 Dose 11, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 2, MRD 12 to 15 Cohorts: Pooled Placebo n=8 Participants TAK-510 placebo-matching placebo, injection, subcutaneously from Days 1 to 5.	Part 2, MRD Cohort 12: Dose 1A n=8 Participants TAK-510 Dose 1A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from SRD Part 1.	Part 2, MRD Cohort 13: Dose 2A n=6 Participants TAK-510 Dose 2A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and available PK data from previous MRD Cohort.	Part 2, MRD Cohort 14: Dose 3A n=6 Participants TAK-510 Dose 3A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.	Part 2, MRD Cohort 15: Dose 4A n=6 Participants TAK-510 Dose 4A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.
Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE)	10 Participants	1 Participants	3 Participants	3 Participants	4 Participants	6 Participants	6 Participants	4 Participants	6 Participants	4 Participants	6 Participants	6 Participants	5 Participants	7 Participants	3 Participants	6 Participants	5 Participants

SECONDARY outcome

Timeframe: Part 3: From the first dose of study drug up to Day 29

Population: No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.

Vital signs included systolic and diastolic blood pressure, body temperature, PR, respiratory rate, orthostatic blood pressure and pulse rate assessments. The MAV criteria for vital signs were systolic SBP \< 85 mmHg, \>180 mmHg; DBP \<50 mmHg, \>110 mmHg; body temperature \<35.6 degree Celsius, \>37.7 degree Celsius; PR \<50 bpm, \>120 bpm; respiratory rate \<12 breaths/minute, \>16 breaths/minute; orthostatic hypotension decrease in SBP \>=20 mmHg or a decrease in DBP \>=10 mmHg on standing; orthostatic tachycardia defined as an increase of \>30 bpm or HR \>120 bpm on standing. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Part 3: From the first dose of study drug up to Day 29

ECG included HR, PR, QT QTcF interval and QRS duration. The MAV criteria for 12-lead ECG parameters included heart rate \<50 bpm, \>120 bpm; PR interval \<=80 msec, \>=200 msec; QTcF interval \>=500 msec or \>=30 msec change from baseline and \>=450 msec; QRS duration \<=80 msec, \>=120 msec. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Part 3: From the first dose of study drug up to Day 29

MAV criteria: hemoglobin \<0.8\*LLN,\>1.2\*ULN; hematocrit \<0.8\*LLN,\>1.2\*ULN;RBC count \<0.8\*LLN, \>1.2\*ULN;WBC count \<0.5\*LLN, \>1.5\*ULN; platelet count \<75\*10\^9 per liter, \>600\*10\^9 per liter; ALT \>3\*ULN; AST \>3\*ULN,GGT \>3\*ULN, normal baseline; \>2\*baseline,abnormal baseline; ALP\>3\*ULN, normal baseline; \>2\*baseline, abnormal baseline; total bilirubin \>1.5\*ULN, normal baseline; \>1.5\* baseline, abnormal baseline; albumin \<25g/L; total protein \<0.8\* LLN, \>1.2\*ULN; creatinine \>177 micromole per liter; blood urea nitrogen \>10.7 mmol/L; sodium \<130 mmol/L, \>150mmol/L; potassium \<3.0mmol/L, \>5.5 mmol/L; glucose \<3mmol/L, \>10mmol/L; chloride \<75mmol/L, \>126mmol/L; calcium corrected serum calcium of \<LLN-8.0 mg/dL; \<LLN-2.0mmol/L; ionized calcium \<LLN-1.0mmol/L; bicarbonate \<8.0mmol/L. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3. Hence, no data collection and assessment were done in Part 3.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Part 3: From the first dose of study drug until 30 days after last dose (up to Day 37)

A TEAE was defined as an AE that started or worsened after first dose of the study treatment and within 30 days of last dose of study treatment. An AE was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it did not necessarily had to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it was considered related to the drug. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Parts 1 and 2: From the first dose of study drug up to Day 29

Population: The immunogenicity analysis set included all participants who received at least 1 dose of study treatment and had the baseline sample and at least 1 postbaseline sample.

A 3-tiered ADA testing strategy was used in this study. A sample was initially screened for ADA by the ADA screening assay. Any positive sample in the screening assay was considered a potential positive, which was confirmed for true positivity by the confirmatory assay. If a sample was confirmed as an ADA true positive, ADA titer was assessed. ADA positive was defined as participants who had confirmed positive ADA status in at least 1 postbaseline assessments. ADA negative was defined as participants who did not have a confirmed negative ADA status in any post-baseline assessment.

Outcome measures

Outcome measures
Measure	Part 1, SRD Cohorts 1 to 11: Pooled Placebo n=23 Participants TAK-510 placebo-matching injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 1: TAK-510 Dose 1 n=6 Participants TAK-510 Dose 1, injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 2: TAK-510 Dose 2 n=6 Participants TAK-510 Dose 2, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort 1.	Part 1, SRD Cohort 3: TAK-510 Dose 3 n=6 Participants TAK-510 Dose 3, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 4: TAK-510 Dose 4 n=7 Participants TAK-510 Dose 4, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 5: TAK-510 Dose 5 n=6 Participants TAK-510 Dose 5, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 6: TAK-510 Dose 6 n=5 Participants TAK-510 Dose 6, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 7: TAK-510 Dose 7 n=6 Participants TAK-510 Dose 7, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 8: TAK-510 Dose 8 n=6 Participants TAK-510 Dose 8, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 9: TAK-510 Dose 9 n=6 Participants TAK-510 Dose 9, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 10: TAK-510 Dose 10 n=5 Participants TAK-510 Dose 10, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 11: TAK-510 Dose 11 n=6 Participants TAK-510 Dose 11, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 2, MRD 12 to 15 Cohorts: Pooled Placebo n=8 Participants TAK-510 placebo-matching placebo, injection, subcutaneously from Days 1 to 5.	Part 2, MRD Cohort 12: Dose 1A n=6 Participants TAK-510 Dose 1A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from SRD Part 1.	Part 2, MRD Cohort 13: Dose 2A n=6 Participants TAK-510 Dose 2A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and available PK data from previous MRD Cohort.	Part 2, MRD Cohort 14: Dose 3A n=6 Participants TAK-510 Dose 3A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.	Part 2, MRD Cohort 15: Dose 4A n=6 Participants TAK-510 Dose 4A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.
Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum ADA Positive	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum ADA Negative	20 Participants	6 Participants	6 Participants	6 Participants	7 Participants	6 Participants	5 Participants	6 Participants	5 Participants	4 Participants	5 Participants	6 Participants	8 Participants	6 Participants	6 Participants	6 Participants	4 Participants

SECONDARY outcome

Timeframe: Part 3: From the first dose of study drug up to Day 29

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Parts 1 and 2: From the first dose of study drug up to Day 29

Population: The immunogenicity analysis set included all participants who received at least 1 dose of study treatment and had the baseline sample and at least 1 postbaseline sample. Here "overall number of participants analyzed" signifies those participants who had positive ADA status in at least 1 postbaseline assessments.

Outcome measures

Outcome measures
Measure	Part 1, SRD Cohorts 1 to 11: Pooled Placebo n=3 Participants TAK-510 placebo-matching injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 1: TAK-510 Dose 1 TAK-510 Dose 1, injection, subcutaneously, once on Day 1.	Part 1, SRD Cohort 2: TAK-510 Dose 2 TAK-510 Dose 2, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort 1.	Part 1, SRD Cohort 3: TAK-510 Dose 3 TAK-510 Dose 3, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 4: TAK-510 Dose 4 TAK-510 Dose 4, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 5: TAK-510 Dose 5 TAK-510 Dose 5, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 6: TAK-510 Dose 6 TAK-510 Dose 6, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 7: TAK-510 Dose 7 TAK-510 Dose 7, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 8: TAK-510 Dose 8 n=1 Participants TAK-510 Dose 8, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 9: TAK-510 Dose 9 n=2 Participants TAK-510 Dose 9, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 10: TAK-510 Dose 10 TAK-510 Dose 10, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 1, SRD Cohort 11: TAK-510 Dose 11 TAK-510 Dose 11, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.	Part 2, MRD 12 to 15 Cohorts: Pooled Placebo TAK-510 placebo-matching placebo, injection, subcutaneously from Days 1 to 5.	Part 2, MRD Cohort 12: Dose 1A TAK-510 Dose 1A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from SRD Part 1.	Part 2, MRD Cohort 13: Dose 2A TAK-510 Dose 2A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and available PK data from previous MRD Cohort.	Part 2, MRD Cohort 14: Dose 3A TAK-510 Dose 3A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.	Part 2, MRD Cohort 15: Dose 4A n=2 Participants TAK-510 Dose 4A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.
Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer ADA Titer Low	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer ADA Titer High	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Part 3: From the first dose of study drug up to Day 29

The high ADA titer was defined as participant who has at least 1 post-baseline ADA titer \>16 and low ADA titer was defined as participant whose postbaseline ADA titers are all \<=16. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose; Part 2, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose