TAK-510 placebo-matching solution.

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

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

MAV criteria: hemoglobin <0.8*LLN,>1.2*ULN; hematocrit <0.8*LLN,>1.2*ULN;RBC count <0.8*LLN, >1.2*ULN;WBC count <0.5*LLN, >1.5*ULN; platelet count <75*10^9 per liter, >600*10^9 per liter; ALT >3*ULN; AST >3*ULN,GGT >3*ULN, normal baseline; >2*baseline,abnormal baseline; ALP>3*ULN, normal baseline; >2*baseline, abnormal baseline; total bilirubin >1.5*ULN, normal baseline; >1.5* baseline, abnormal baseline; albumin <25g/L; total protein <0.8* LLN, >1.2*ULN; creatinine >177 micromole per liter; blood urea nitrogen >10.7 mmol/L; sodium <130 mmol/L, >150mmol/L; potassium <3.0mmol/L, >5.5 mmol/L; glucose <3mmol/L, >10mmol/L; chloride <75mmol/L, >126mmol/L; calcium corrected serum calcium of \

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

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

A 3-tiered ADA testing strategy was used in this study. A sample was initially screened for ADA by the ADA screening assay. Any positive sample in the screening assay was considered a potential positive, which was confirmed for true positivity by the confirmatory assay. If a sample was confirmed as an ADA true positive, ADA titer was assessed. ADA positive was defined as participants who had confirmed positive ADA status in at least 1 postbaseline assessments. ADA negative was defined as participants who did not have a confirmed negative ADA status in any post-baseline assessment. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.

The high ADA titer was defined as participant who has at least 1 post-baseline ADA titer >16 and low ADA titer was defined as participant whose postbaseline ADA titers are all <=16. The low or high ADA titer was assessed in ADA positive participants only.

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

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

TAK-510 Dose 2, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort 1.

TAK-510 Dose 3, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 4, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 5, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 6, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 7, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 8, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 9, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 10, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 11, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 placebo-matching placebo, injection, subcutaneously from Days 1 to 5.

TAK-510 Dose 1A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from SRD Part 1.

TAK-510 Dose 2A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and available PK data from previous MRD Cohort.

TAK-510 Dose 3A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.

TAK-510 Dose 4A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.

Total of all reporting groups

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

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

Clinical laboratory parameters included tests for chemistry and hematology. The MAV criteria for laboratory value included hemoglobin <0.8*LLN,>1.2*ULN; hematocrit <0.8*LLN,>1.2*ULN;RBC count <0.8*LLN, >1.2*ULN;WBC count <0.5*LLN, >1.5*ULN; platelet count <75*10^9 per liter, >600*10^9 per liter; ALT >3*ULN; AST >3*ULN,GGT >3*ULN, normal baseline; >2*baseline,abnormal baseline; ALP>3*ULN, normal baseline; >2*baseline, abnormal baseline; total bilirubin >1.5*ULN, normal baseline; >1.5* baseline, abnormal baseline; albumin <25g/L; total protein <0.8* LLN, >1.2*ULN; creatinine >177 micromole per liter; blood urea nitrogen >10.7 mmol/L; sodium <130 mmol/L, >150mmol/L; potassium <3.0mmol/L, >5.5 mmol/L; glucose <3mmol/L, >10mmol/L; chloride <75mmol/L, >126mmol/L; calcium corrected serum calcium of \

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

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

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

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

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

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

MAV criteria: hemoglobin <0.8*LLN,>1.2*ULN; hematocrit <0.8*LLN,>1.2*ULN;RBC count <0.8*LLN, >1.2*ULN;WBC count <0.5*LLN, >1.5*ULN; platelet count <75*10^9 per liter, >600*10^9 per liter; ALT >3*ULN; AST >3*ULN,GGT >3*ULN, normal baseline; >2*baseline,abnormal baseline; ALP>3*ULN, normal baseline; >2*baseline, abnormal baseline; total bilirubin >1.5*ULN, normal baseline; >1.5* baseline, abnormal baseline; albumin <25g/L; total protein <0.8* LLN, >1.2*ULN; creatinine >177 micromole per liter; blood urea nitrogen >10.7 mmol/L; sodium <130 mmol/L, >150mmol/L; potassium <3.0mmol/L, >5.5 mmol/L; glucose <3mmol/L, >10mmol/L; chloride <75mmol/L, >126mmol/L; calcium corrected serum calcium of \

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

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

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

A 3-tiered ADA testing strategy was used in this study. A sample was initially screened for ADA by the ADA screening assay. Any positive sample in the screening assay was considered a potential positive, which was confirmed for true positivity by the confirmatory assay. If a sample was confirmed as an ADA true positive, ADA titer was assessed. ADA positive was defined as participants who had confirmed positive ADA status in at least 1 postbaseline assessments. ADA negative was defined as participants who did not have a confirmed negative ADA status in any post-baseline assessment. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.

The high ADA titer was defined as participant who has at least 1 post-baseline ADA titer >16 and low ADA titer was defined as participant whose postbaseline ADA titers are all <=16. The low or high ADA titer was assessed in ADA positive participants only.

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

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

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.

TAK-510 Dose 1, injection, subcutaneously, once on Day 1.

TAK-510 Dose 2, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort 1.

TAK-510 Dose 3, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 4, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 5, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 6, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 7, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 8, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 9, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 10, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 Dose 11, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort.

TAK-510 placebo-matching placebo, injection, subcutaneously from Days 1 to 5.

TAK-510 Dose 1A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from SRD Part 1.

TAK-510 Dose 2A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and available PK data from previous MRD Cohort.

TAK-510 Dose 3A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.

TAK-510 Dose 4A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort.