Trial Outcomes & Findings for A Study of TAK-951 in Healthy Adults (NCT NCT06610279)

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug. An AE can be any unfavorable and unintended sign (including physical examinations, vital signs, electrocardiogram (ECG), laboratory assessment findings), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

48 participants

Primary outcome timeframe

From the first dose of study drug up to Day 29 in Part 1

Results posted on

2024-11-22

Participant Flow

Participants took part in the study at 2 investigative sites in the United States from 7 January 2022 to 21 September 2023.

A total of 48 healthy participants were enrolled in Part 1 Single Rising Dose (SRD) of the study and randomized to receive either placebo or TAK-951. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3.

Participant milestones

Participant milestones
Measure	Part 1: Pooled Placebo Participants received a single subcutaneous (SC) dose of TAK-951 matching placebo on Day 1.	Part 1, Cohort 1: TAK-951 Dose 1 Participants received a single SC dose of TAK-951 Dose 1 on Day 1.	Part 1, Cohort 2: TAK-951 Dose 2 Participants received a single SC dose of TAK-951 Dose 2 on Day 1.	Part 1, Cohort 3: TAK-951 Dose 3 Participants received a single SC dose of TAK-951 Dose 3 on Day 1.	Part 1, Cohort 4: TAK-951 Dose 4 Participants received a single SC dose of TAK-951 Dose 4 on Day 1.	Part 1, Cohort 5: TAK-951 Dose 5 Participants received a single SC dose of TAK-951 Dose 5 on Day 1.	Part 1, Cohort 6: TAK-951 Dose 6 Participants received a single SC dose of TAK-951 Dose 6 on Day 1.
Part 1 STARTED	12	6	6	6	6	6	6
Part 1 COMPLETED	12	6	6	6	6	6	6
Part 1 NOT COMPLETED	0	0	0	0	0	0	0
Part 2 STARTED	0	0	0	0	0	0	0
Part 2 COMPLETED	0	0	0	0	0	0	0
Part 2 NOT COMPLETED	0	0	0	0	0	0	0
Part 3 STARTED	0	0	0	0	0	0	0
Part 3 COMPLETED	0	0	0	0	0	0	0
Part 3 NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of TAK-951 in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Pooled Placebo n=12 Participants Participants received a single SC dose of TAK-951 matching placebo on Day 1.	Part 1, Cohort 1: TAK-951 Dose 1 n=6 Participants Participants received a single SC dose of TAK-951 Dose 1 on Day 1.	Part 1, Cohort 2: TAK-951 Dose 2 n=6 Participants Participants received a single SC dose of TAK-951 Dose 2 on Day 1.	Part 1, Cohort 3: TAK-951 Dose 3 n=6 Participants Participants received a single SC dose of TAK-951 Dose 3 on Day 1.	Part 1, Cohort 4: TAK-951 Dose 4 n=6 Participants Participants received a single SC dose of TAK-951 Dose 4 on Day 1.	Part 1, Cohort 5: TAK-951 Dose 5 n=6 Participants Participants received a single SC dose of TAK-951 Dose 5 on Day 1.	Part 1, Cohort 6: TAK-951 Dose 6 n=6 Participants Participants received a single SC dose of TAK-951 Dose 6 on Day 1.	Part 2, TAK-951 Multiple Rising Dose Cohort Participants were planned to receive multiple rising SC doses of TAK-951 BID or TID in Part 2.	Part 3, TAK-951 Multiple Dose Titration Cohort Participants were planned to receive multiple rising SC doses of TAK-951 QD, BID, or TID from Days 1 to 5 followed by a washout period of 2 to 7 days and a single redose on any day from Days 8 to 13 in Part 3.	Total n=48 Participants Total of all reporting groups
Age, Continuous	33.36 years STANDARD_DEVIATION 10.68 • n=5 Participants	34.5 years STANDARD_DEVIATION 10.07 • n=7 Participants	35.2 years STANDARD_DEVIATION 5.91 • n=5 Participants	31.7 years STANDARD_DEVIATION 9.71 • n=4 Participants	30.0 years STANDARD_DEVIATION 8.92 • n=21 Participants	28.0 years STANDARD_DEVIATION 11.10 • n=10 Participants	40.2 years STANDARD_DEVIATION 10.09 • n=115 Participants	—	—	33.3 years STANDARD_DEVIATION 9.78 • n=64 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	10 Participants n=64 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	4 Participants n=10 Participants	3 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	38 Participants n=64 Participants
Ethnicity (NIH/OMB) Ethnicity · Hispanic or Latino	5 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	13 Participants n=64 Participants
Ethnicity (NIH/OMB) Ethnicity · Not Hispanic or Latino	7 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=10 Participants	4 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	35 Participants n=64 Participants
Ethnicity (NIH/OMB) Ethnicity · 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
Race (NIH/OMB) Race · American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants
Race (NIH/OMB) Race · Asian	0 Participants n=5 Participants	1 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	1 Participants n=64 Participants
Race (NIH/OMB) Race · Native Hawaiian or Other Pacific Islander	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	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants
Race (NIH/OMB) Race · Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 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	5 Participants n=64 Participants
Race (NIH/OMB) Race · White	8 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=10 Participants	6 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	36 Participants n=64 Participants
Race (NIH/OMB) Race · More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 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	4 Participants n=64 Participants
Race (NIH/OMB) Race · 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

PRIMARY outcome

Timeframe: From the first dose of study drug up to Day 29 in Part 1

Population: The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment.

An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug. An AE can be any unfavorable and unintended sign (including physical examinations, vital signs, electrocardiogram (ECG), laboratory assessment findings), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug.

Outcome measures

Outcome measures
Measure	Part 1, Cohort 6: TAK-951 Dose 6 n=6 Participants Participants received a single SC dose of TAK-951 Dose 6 on Day 1.	Part 2, TAK-951 Multiple Rising Dose Cohort n=12 Participants Participants were planned to receive multiple rising SC doses of TAK-951 BID or TID in Part 2.	Part 1, Cohort 1: TAK-951 Dose 1 n=6 Participants Participants received a single SC dose of TAK-951 Dose 1 on Day 1.	Part 1, Cohort 2: TAK-951 Dose 2 n=6 Participants Participants received a single SC dose of TAK-951 Dose 2 on Day 1.	Part 1, Cohort 3: TAK-951 Dose 3 n=6 Participants Participants received a single SC dose of TAK-951 Dose 3 on Day 1.	Part 1, Cohort 4: TAK-951 Dose 4 n=6 Participants Participants received a single SC dose of TAK-951 Dose 4 on Day 1.	Part 1, Cohort 5: TAK-951 Dose 5 n=6 Participants Participants received a single SC dose of TAK-951 Dose 5 on Day 1.
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)	6 Participants	6 Participants	4 Participants	5 Participants	6 Participants	5 Participants	4 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug up to Day 33 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug. An AE can be any unfavorable and unintended sign (including physical examinations, vital signs, ECG, laboratory assessment findings), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From the first dose of study drug up to Day 27 in Part 3

Population: Data was not collected as no participants were enrolled in Part 3 due to study termination.

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug. An AE can be any unfavorable and unintended sign (including physical examinations, vital signs, ECG, laboratory assessment findings), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

Tau (τ) indicates the length of the dosing interval.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

τ indicates the length of the dosing interval.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to 24 hours on Day 1 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

Apparent clearance after extravascular administration was to be calculated as Dose/AUCτ after multiple dosing.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

Apparent volume of distribution during the terminal disposition phase after extravascular administration was to be calculated as (CL/F)/λz at steady state, with λz as the terminal elimination rate constant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

Rac\[AUC\] was to be calculated as the ratio of AUCτ at steady state/AUCτ after a single dose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

Rac\[Cmax\] was to be calculated as the ratio of Cmax at steady state/Cmax after a single dose.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the re-treatment dose of study drug (any day from Days 8 to 13) up to Day 27 in Part 3

Population: Data was not collected as no participants were enrolled in Part 3 due to study termination.

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug. An AE can be any unfavorable and unintended sign (including physical examinations, vital signs, ECG, laboratory assessment findings), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose on Day 1 and post-dose on Days 14 and 29 in Part 1

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 ADA assessment.

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 have confirmed positive ADA status in at least 1 postbaseline assessments. ADA-negative was defined as participants who did not have a confirmed positive ADA status in any postbaseline assessment. For ADA-positive only, high ADA titer was defined as participant who had at least 1 postbaseline ADA titer \>16; low ADA titer was defined as participant whose postbaseline ADA titers were all ≤16 and data is presented accordingly for each of these categories.

Outcome measures

Outcome measures
Measure	Part 1, Cohort 6: TAK-951 Dose 6 n=6 Participants Participants received a single SC dose of TAK-951 Dose 6 on Day 1.	Part 2, TAK-951 Multiple Rising Dose Cohort n=12 Participants Participants were planned to receive multiple rising SC doses of TAK-951 BID or TID in Part 2.	Part 1, Cohort 1: TAK-951 Dose 1 n=6 Participants Participants received a single SC dose of TAK-951 Dose 1 on Day 1.	Part 1, Cohort 2: TAK-951 Dose 2 n=6 Participants Participants received a single SC dose of TAK-951 Dose 2 on Day 1.	Part 1, Cohort 3: TAK-951 Dose 3 n=6 Participants Participants received a single SC dose of TAK-951 Dose 3 on Day 1.	Part 1, Cohort 4: TAK-951 Dose 4 n=6 Participants Participants received a single SC dose of TAK-951 Dose 4 on Day 1.	Part 1, Cohort 5: TAK-951 Dose 5 n=6 Participants Participants received a single SC dose of TAK-951 Dose 5 on Day 1.
Part 1: Number of Participants Based on Antidrug Antibodies (ADA) Status in Serum Day 14: Negative	6 Participants	12 Participants	6 Participants	6 Participants	6 Participants	5 Participants	6 Participants
Part 1: Number of Participants Based on Antidrug Antibodies (ADA) Status in Serum Day 1: Positive: Low Titer	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Part 1: Number of Participants Based on Antidrug Antibodies (ADA) Status in Serum Day 1: Positive: High Titer	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants Based on Antidrug Antibodies (ADA) Status in Serum Day 29: Positive: Low Titer	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Part 1: Number of Participants Based on Antidrug Antibodies (ADA) Status in Serum Day 1: Negative	6 Participants	12 Participants	6 Participants	6 Participants	6 Participants	5 Participants	6 Participants
Part 1: Number of Participants Based on Antidrug Antibodies (ADA) Status in Serum Day 14: Positive: Low Titer	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Part 1: Number of Participants Based on Antidrug Antibodies (ADA) Status in Serum Day 29: Negative	6 Participants	12 Participants	6 Participants	6 Participants	6 Participants	5 Participants	6 Participants
Part 1: Number of Participants Based on Antidrug Antibodies (ADA) Status in Serum Day 14: Positive: High Titer	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Part 1: Number of Participants Based on Antidrug Antibodies (ADA) Status in Serum Day 29: Positive: High Titer	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Predose on Day 1 and post-dose on Days 14 and 29 in Part 2

Population: Data was not collected as no participants were enrolled in Part 2 due to study termination.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Predose on Day 1 and post-dose on Days 14 and 29 in Part 3

Population: Data was not collected as no participants were enrolled in Part 3 due to study termination.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to Day 3 in Part 1

Due to confidentiality reasons and chances of exposing the doses for TAK-951, the data for this pharmacokinetic outcome measure was not reported.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 1

Due to confidentiality reasons and chances of exposing the doses for TAK-951, the data for this pharmacokinetic outcome measure was not reported.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to Day 3 in Part 1

Due to confidentiality reasons and chances of exposing the doses for TAK-951, the data for this pharmacokinetic outcome measure was not reported.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to Day 3 in Part 1

Due to confidentiality reasons and chances of exposing the doses for TAK-951, the data for this pharmacokinetic outcome measure was not reported.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to Day 3 in Part 1

Due to confidentiality reasons and chances of exposing the doses for TAK-951, the data for this pharmacokinetic outcome measure was not reported.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to Day 3 in Part 1

Due to confidentiality reasons and chances of exposing the doses for TAK-951, the data for this pharmacokinetic outcome measure was not reported.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to Day 3 in Part 1

Apparent clearance after extravascular administration was calculated as Dose/AUC∞. Due to confidentiality reasons and chances of exposing the doses for TAK-951, the data for this pharmacokinetic outcome measure was not reported.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Predose on Day 1 and at multiple time points post-dose up to Day 3 in Part 1

Apparent volume of distribution during the terminal disposition phase after extravascular administration was calculated as (CL/F)/λz, where λz is the terminal elimination rate constant. Due to confidentiality reasons and chances of exposing the doses for TAK-951, the data for this pharmacokinetic outcome measure was not reported.

Outcome measures

Outcome data not reported

Adverse Events

Part 1: Pooled Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 1, Cohort 1: TAK-951 Dose 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 1, Cohort 2: TAK-951 Dose 2

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1, Cohort 3: TAK-951 Dose 3

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 1, Cohort 4: TAK-951 Dose 4

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Part 1, Cohort 5: TAK-951 Dose 5

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 1, Cohort 6: TAK-951 Dose 6

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Pooled Placebo n=12 participants at risk Participants received a single subcutaneous (SC) dose of TAK-951 matching placebo on Day 1.	Part 1, Cohort 1: TAK-951 Dose 1 n=6 participants at risk Participants received a single SC dose of TAK-951 Dose 1 on Day 1.	Part 1, Cohort 2: TAK-951 Dose 2 n=6 participants at risk Participants received a single SC dose of TAK-951 Dose 2 on Day 1.	Part 1, Cohort 3: TAK-951 Dose 3 n=6 participants at risk Participants received a single SC dose of TAK-951 Dose 3 on Day 1.	Part 1, Cohort 4: TAK-951 Dose 4 n=6 participants at risk Participants received a single SC dose of TAK-951 Dose 4 on Day 1.	Part 1, Cohort 5: TAK-951 Dose 5 n=6 participants at risk Participants received a single SC dose of TAK-951 Dose 5 on Day 1.	Part 1, Cohort 6: TAK-951 Dose 6 n=6 participants at risk Participants received a single SC dose of TAK-951 Dose 6 on Day 1.
Nervous system disorders Syncope	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.

Other adverse events

Other adverse events
Measure	Part 1: Pooled Placebo n=12 participants at risk Participants received a single subcutaneous (SC) dose of TAK-951 matching placebo on Day 1.	Part 1, Cohort 1: TAK-951 Dose 1 n=6 participants at risk Participants received a single SC dose of TAK-951 Dose 1 on Day 1.	Part 1, Cohort 2: TAK-951 Dose 2 n=6 participants at risk Participants received a single SC dose of TAK-951 Dose 2 on Day 1.	Part 1, Cohort 3: TAK-951 Dose 3 n=6 participants at risk Participants received a single SC dose of TAK-951 Dose 3 on Day 1.	Part 1, Cohort 4: TAK-951 Dose 4 n=6 participants at risk Participants received a single SC dose of TAK-951 Dose 4 on Day 1.	Part 1, Cohort 5: TAK-951 Dose 5 n=6 participants at risk Participants received a single SC dose of TAK-951 Dose 5 on Day 1.	Part 1, Cohort 6: TAK-951 Dose 6 n=6 participants at risk Participants received a single SC dose of TAK-951 Dose 6 on Day 1.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Investigations Blood creatine phosphokinase increased	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Gastrointestinal disorders Diarrhoea	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Nervous system disorders Dizziness	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Gastrointestinal disorders Dry mouth	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Nervous system disorders Dysaesthesia	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Respiratory, thoracic and mediastinal disorders Epistaxis	8.3% 1/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
General disorders Fatigue	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
General disorders Feeling hot	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Vascular disorders Flushing	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Nervous system disorders Head discomfort	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Nervous system disorders Headache	8.3% 1/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Skin and subcutaneous tissue disorders Hyperhidrosis	8.3% 1/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
General disorders Injection site reaction	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	33.3% 2/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	33.3% 2/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Gastrointestinal disorders Nausea	16.7% 2/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Vascular disorders Orthostatic hypotension	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	50.0% 3/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	33.3% 2/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	33.3% 2/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Cardiac disorders Palpitations	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Nervous system disorders Presyncope	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	33.3% 2/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	33.3% 2/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	16.7% 1/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Cardiac disorders Tachycardia	16.7% 2/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	33.3% 2/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	33.3% 2/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	83.3% 5/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	33.3% 2/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	66.7% 4/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	83.3% 5/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.
Infections and infestations Tooth abscess	8.3% 1/12 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.	0.00% 0/6 • From the first dose of study drug up to Day 29 in Part 1 The Safety Analysis Set included all participants who were randomized and received at least 1 dose of study treatment was used to collect safety data for Part 1. This study was terminated after completion of Part 1 following the Sponsor's decision attributed to the benefit-risk profile derived from the Part 1 data. Hence, no participants were enrolled in Parts 2 and 3 and no data for the same could be presented.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place