Autoimmune Disease
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this study is to characterize the pharmacokinetic and safety and tolerability profile of TAK-079 following a single intravenous (IV) infusion or subcutaneous (SC) administration at escalating dose levels in healthy participants.
Detailed description
The drug being tested in this study is TAK-079. TAK-079 is being tested to find a safe and well-tolerated dose and to assess how TAK-079 is processed by the body. This study will look at pharmacokinetics, side effects, and laboratory results in people who take TAK-079 and is designed as a randomized single dose-rising study. Therefore, each subsequent cohort will not start until the previous cohort has completed and the results are reviewed. Each participant will receive TAK-079 or placebo once only as an IV infusion or by SC administration. The starting dose for IV will be 0.0003 mg/kg and SC dose of 0.01 or 0.03 mg/kg was determined based on the no-observed-adverse-effect-level (NOAEL) results from the 13-week good laboratory practice (GLP) monkey toxicology study. If this dose is well-tolerated, the next group will receive a higher dose, etc, until a maximal tolerated dose is reached with the highest dose not to exceed 1.0 mg/kg. This single-center trial will be conducted in the United Kingdom. The overall time to participate in this study is up to 17 weeks. Participants will make 11 visits to the clinic, including one 10-day period of confinement in the clinic. All participants will be contacted by telephone 14 days after the last visit to the clinic for a follow-up assessment.
Interventions
DRUGTAK-079
TAK-079 solution
DRUGPlacebo to TAK-079
Placebo to TAK-079 solution
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Is a healthy male or female with no child bearing potential who is 18 to 55 years of age inclusive. 2. The subject weighs at least 70 kilogram (kg) for cohort 1 and subsequent cohorts 50 kg (110.2 lb) and less than 100 kg (220.5 lb) and has a body mass index (BMI) range of 18.5 to 30 kilogram per square meter (kg/m\^2), inclusive at Screening Visit 1. 3. A male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 6 months after last dose of study medication.
Exclusion criteria
1. Has received any investigational compound within the last 3 months or 5\*T1/2 of the investigational compound,whichever is longer, prior to the day of study medication (Day 1). 2. Has received any live vaccinations, within the last 3 months prior to Screening or is expected to receive any vaccinations during the study or for 1 month after the Day 78 Study Exit visit. 3. Has received any other biologic medical products at any time in the past. 4. Has a positive drug or alcohol screening result, or a history of drug or alcohol abuse. 5. Has a positive test result for hepatitis or human immunodeficiency virus antibody. 6. Has any signs of an acute infection or history of frequent or chronic infection, or herpes zoster. 7. Has active or latent tuberculosis (TB) 8. Considered unfit for the study by the Principal Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | First dose up to Day 78 | — |
| Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | First dose up to Day 94 | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE was assessed according to severity; mild (transient and easily tolerated by the participant), moderate (causes the participant discomfort and interrupts the participant's usual activities) and severe (causes considerable interference with the participant's usual activities). |
| Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | First dose up to Day 78 | — |
| Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | First dose up to Day 78 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-079 | Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose | — |
| Cmax: Maximum Observed Serum Concentration for TAK-079 | Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose | — |
| AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079 | Day 1 pre-dose and at multiple time points (up to Day 78) post-dose | — |
| Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) | Baseline up to Day 78 | Results for ADA analysis were reported. |
Countries
United Kingdom
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in the United Kingdom (UK) from 01 August 2014 to 29 April 2016.
Pre-assignment details
Healthy participants were enrolled in 1 of 12 treatment groups to receive: TAK-079 placebo, 0.0003, 0.001, 0.003, 0.01, 0.03, 0.06 milligram per kilogram (mg/kg) Intravenously (IV) and TAK-079 placebo, 0.03, 0.1, 0.3, 0.6 mg/kg subcutaneously (SC).
Participants by arm
| Arm | Count |
|---|---|
| TAK-079 Pooled Placebo IV TAK-079 placebo-matching, infusion solution, IV, once on Day 1. | 12 |
| TAK-079 0.0003 mg/kg IV TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1. | 4 |
| TAK-079 0.001 mg/kg IV TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1. | 4 |
| TAK-079 0.003 mg/kg IV TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1. | 4 |
| TAK-079 0.01 mg/kg IV TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1. | 6 |
| TAK-079 0.03 mg/kg IV TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1. | 6 |
| TAK-079 0.06 mg/kg IV TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1. | 6 |
| TAK-079 Pooled Placebo SC TAK-079 placebo-matching, infusion solution, SC, once on Day 1. | 8 |
| TAK-079 0.03 mg/kg SC TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1. | 6 |
| TAK-079 0.1 mg/kg SC TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1 | 6 |
| TAK-079 0.3 mg/kg SC TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1. | 6 |
| TAK-079 0.6 mg/kg SC TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1. | 6 |
| Total | 74 |
Baseline characteristics
| Characteristic | TAK-079 0.0003 mg/kg IV | TAK-079 0.001 mg/kg IV | TAK-079 0.003 mg/kg IV | TAK-079 0.01 mg/kg IV | TAK-079 0.03 mg/kg IV | TAK-079 0.06 mg/kg IV | TAK-079 Pooled Placebo IV | TAK-079 Pooled Placebo SC | TAK-079 0.03 mg/kg SC | TAK-079 0.1 mg/kg SC | TAK-079 0.3 mg/kg SC | TAK-079 0.6 mg/kg SC | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 23.5 years STANDARD_DEVIATION 3.42 | 42.3 years STANDARD_DEVIATION 12.12 | 32.8 years STANDARD_DEVIATION 10.72 | 36.2 years STANDARD_DEVIATION 9.52 | 32.3 years STANDARD_DEVIATION 5.92 | 35.7 years STANDARD_DEVIATION 11.6 | 35.5 years STANDARD_DEVIATION 10.61 | 34.9 years STANDARD_DEVIATION 13.61 | 36.7 years STANDARD_DEVIATION 10.33 | 31.0 years STANDARD_DEVIATION 8.15 | 40.8 years STANDARD_DEVIATION 7.83 | 27.7 years STANDARD_DEVIATION 8.16 | 34.3 years STANDARD_DEVIATION 10.19 |
| Alcohol Classification Drinks everyday | 1 participants | 2 participants | 1 participants | 3 participants | 1 participants | 4 participants | 5 participants | 2 participants | 4 participants | 1 participants | 2 participants | 4 participants | 30 participants |
| Alcohol Classification Never drank | 3 participants | 2 participants | 3 participants | 3 participants | 5 participants | 2 participants | 7 participants | 6 participants | 2 participants | 5 participants | 4 participants | 2 participants | 44 participants |
| Body Mass Index (BMI) | 24.53 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.337 | 25.05 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.456 | 22.33 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.176 | 24.93 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.42 | 22.45 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.118 | 23.60 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.383 | 24.32 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.507 | 24.80 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.311 | 25.52 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.763 | 22.85 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 1.947 | 25.22 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.225 | 23.98 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.064 | 24.18 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.553 |
| Caffeine Classification Had caffeine consumption | 3 participants | 3 participants | 1 participants | 6 participants | 6 participants | 3 participants | 9 participants | 3 participants | 3 participants | 6 participants | 5 participants | 2 participants | 50 participants |
| Caffeine Classification Had no caffeine consumption | 1 participants | 1 participants | 3 participants | 0 participants | 0 participants | 3 participants | 3 participants | 5 participants | 3 participants | 0 participants | 1 participants | 4 participants | 24 participants |
| Height | 181.3 centimeter (cm) STANDARD_DEVIATION 6.9 | 175.0 centimeter (cm) STANDARD_DEVIATION 8.04 | 179.5 centimeter (cm) STANDARD_DEVIATION 10.91 | 173.8 centimeter (cm) STANDARD_DEVIATION 1.47 | 175.5 centimeter (cm) STANDARD_DEVIATION 7.97 | 173.8 centimeter (cm) STANDARD_DEVIATION 7.03 | 174.7 centimeter (cm) STANDARD_DEVIATION 9.17 | 177.8 centimeter (cm) STANDARD_DEVIATION 7.91 | 176.8 centimeter (cm) STANDARD_DEVIATION 3.31 | 181.2 centimeter (cm) STANDARD_DEVIATION 8.8 | 177.8 centimeter (cm) STANDARD_DEVIATION 6.68 | 172.3 centimeter (cm) STANDARD_DEVIATION 4.32 | 176.3 centimeter (cm) STANDARD_DEVIATION 7.32 |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants | 0 participants | 2 participants | 1 participants | 2 participants | 3 participants | 0 participants | 3 participants | 13 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized Multiracial | 1 participants | 1 participants | 0 participants | 2 participants | 0 participants | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 6 participants |
| Race/Ethnicity, Customized White | 3 participants | 2 participants | 3 participants | 4 participants | 5 participants | 5 participants | 8 participants | 6 participants | 4 participants | 3 participants | 6 participants | 2 participants | 51 participants |
| Region of Enrollment United Kingdom | 4 participants | 4 participants | 4 participants | 6 participants | 6 participants | 6 participants | 12 participants | 8 participants | 6 participants | 6 participants | 6 participants | 6 participants | 74 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 4 Participants | 6 Participants | 6 Participants | 6 Participants | 12 Participants | 7 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 73 Participants |
| Smoking Classification Currently smoking | 0 participants | 1 participants | 0 participants | 1 participants | 3 participants | 0 participants | 4 participants | 0 participants | 1 participants | 1 participants | 1 participants | 1 participants | 13 participants |
| Smoking Classification Ex-smoker | 2 participants | 1 participants | 1 participants | 2 participants | 1 participants | 2 participants | 2 participants | 1 participants | 2 participants | 1 participants | 1 participants | 1 participants | 17 participants |
| Smoking Classification Never smoked | 2 participants | 2 participants | 3 participants | 3 participants | 2 participants | 4 participants | 6 participants | 7 participants | 3 participants | 4 participants | 4 participants | 4 participants | 44 participants |
| Weight | 80.63 kilogram (kg) STANDARD_DEVIATION 8.768 | 76.68 kilogram (kg) STANDARD_DEVIATION 9.011 | 72.10 kilogram (kg) STANDARD_DEVIATION 9.09 | 75.45 kilogram (kg) STANDARD_DEVIATION 11.042 | 69.12 kilogram (kg) STANDARD_DEVIATION 8.043 | 71.32 kilogram (kg) STANDARD_DEVIATION 6.187 | 73.98 kilogram (kg) STANDARD_DEVIATION 7.355 | 78.53 kilogram (kg) STANDARD_DEVIATION 12.508 | 79.77 kilogram (kg) STANDARD_DEVIATION 8.584 | 75.18 kilogram (kg) STANDARD_DEVIATION 9.887 | 79.73 kilogram (kg) STANDARD_DEVIATION 8.311 | 71.25 kilogram (kg) STANDARD_DEVIATION 9.434 | 75.20 kilogram (kg) STANDARD_DEVIATION 9.149 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 12 | 3 / 4 | 3 / 4 | 3 / 4 | 6 / 6 | 6 / 6 | 6 / 6 | 6 / 8 | 6 / 6 | 6 / 6 | 5 / 6 | 5 / 6 |
| serious Total, serious adverse events | 0 / 12 | 0 / 4 | 0 / 4 | 0 / 4 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE was assessed according to severity; mild (transient and easily tolerated by the participant), moderate (causes the participant discomfort and interrupts the participant's usual activities) and severe (causes considerable interference with the participant's usual activities).
Time frame: First dose up to Day 94
Population: The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TAK-079 Pooled Placebo IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 participants |
| TAK-079 Pooled Placebo IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Mild | 6 participants |
| TAK-079 Pooled Placebo IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Moderate | 5 participants |
| TAK-079 Pooled Placebo IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Severe | 0 participants |
| TAK-079 0.0003 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Moderate | 0 participants |
| TAK-079 0.0003 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Severe | 0 participants |
| TAK-079 0.0003 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 participants |
| TAK-079 0.0003 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Mild | 3 participants |
| TAK-079 0.001 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Moderate | 1 participants |
| TAK-079 0.001 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Mild | 2 participants |
| TAK-079 0.001 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 participants |
| TAK-079 0.001 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Severe | 0 participants |
| TAK-079 0.003 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Moderate | 2 participants |
| TAK-079 0.003 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Severe | 0 participants |
| TAK-079 0.003 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 participants |
| TAK-079 0.003 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Mild | 1 participants |
| TAK-079 0.01 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Moderate | 1 participants |
| TAK-079 0.01 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 participants |
| TAK-079 0.01 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Mild | 5 participants |
| TAK-079 0.01 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Severe | 0 participants |
| TAK-079 0.03 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Moderate | 2 participants |
| TAK-079 0.03 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Mild | 4 participants |
| TAK-079 0.03 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 participants |
| TAK-079 0.03 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Severe | 0 participants |
| TAK-079 0.06 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Mild | 2 participants |
| TAK-079 0.06 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Severe | 0 participants |
| TAK-079 0.06 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Moderate | 4 participants |
| TAK-079 0.06 mg/kg IV | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 participants |
| TAK-079 Pooled Placebo SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Mild | 3 participants |
| TAK-079 Pooled Placebo SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Moderate | 3 participants |
| TAK-079 Pooled Placebo SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Severe | 0 participants |
| TAK-079 Pooled Placebo SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 participants |
| TAK-079 0.03 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Moderate | 1 participants |
| TAK-079 0.03 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Severe | 0 participants |
| TAK-079 0.03 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Mild | 5 participants |
| TAK-079 0.03 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 participants |
| TAK-079 0.1 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 participants |
| TAK-079 0.1 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Moderate | 2 participants |
| TAK-079 0.1 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Severe | 0 participants |
| TAK-079 0.1 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Mild | 4 participants |
| TAK-079 0.3 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Moderate | 1 participants |
| TAK-079 0.3 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Mild | 4 participants |
| TAK-079 0.3 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Severe | 0 participants |
| TAK-079 0.3 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 participants |
| TAK-079 0.6 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | SAE | 0 participants |
| TAK-079 0.6 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Severe | 0 participants |
| TAK-079 0.6 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Mild | 4 participants |
| TAK-079 0.6 mg/kg SC | Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) | TEAE: Moderate | 1 participants |
Primary
Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Time frame: First dose up to Day 78
Population: The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-079 Pooled Placebo IV | Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | 1 participants |
| TAK-079 0.0003 mg/kg IV | Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | 1 participants |
| TAK-079 0.001 mg/kg IV | Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | 0 participants |
| TAK-079 0.003 mg/kg IV | Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | 0 participants |
| TAK-079 0.01 mg/kg IV | Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | 0 participants |
| TAK-079 0.03 mg/kg IV | Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | 0 participants |
| TAK-079 0.06 mg/kg IV | Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | 0 participants |
| TAK-079 Pooled Placebo SC | Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | 2 participants |
| TAK-079 0.03 mg/kg SC | Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | 0 participants |
| TAK-079 0.1 mg/kg SC | Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | 0 participants |
| TAK-079 0.3 mg/kg SC | Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | 0 participants |
| TAK-079 0.6 mg/kg SC | Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose | 2 participants |
Primary
Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose
Time frame: First dose up to Day 78
Population: The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-079 Pooled Placebo IV | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 8 participants |
| TAK-079 0.0003 mg/kg IV | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 3 participants |
| TAK-079 0.001 mg/kg IV | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 3 participants |
| TAK-079 0.003 mg/kg IV | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 1 participants |
| TAK-079 0.01 mg/kg IV | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 3 participants |
| TAK-079 0.03 mg/kg IV | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 5 participants |
| TAK-079 0.06 mg/kg IV | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 1 participants |
| TAK-079 Pooled Placebo SC | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 5 participants |
| TAK-079 0.03 mg/kg SC | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 4 participants |
| TAK-079 0.1 mg/kg SC | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 5 participants |
| TAK-079 0.3 mg/kg SC | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 1 participants |
| TAK-079 0.6 mg/kg SC | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose | 0 participants |
Primary
Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Time frame: First dose up to Day 78
Population: The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TAK-079 Pooled Placebo IV | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 6 participants |
| TAK-079 0.0003 mg/kg IV | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 2 participants |
| TAK-079 0.001 mg/kg IV | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 2 participants |
| TAK-079 0.003 mg/kg IV | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 2 participants |
| TAK-079 0.01 mg/kg IV | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 1 participants |
| TAK-079 0.03 mg/kg IV | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 4 participants |
| TAK-079 0.06 mg/kg IV | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 6 participants |
| TAK-079 Pooled Placebo SC | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 4 participants |
| TAK-079 0.03 mg/kg SC | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 4 participants |
| TAK-079 0.1 mg/kg SC | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 4 participants |
| TAK-079 0.3 mg/kg SC | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 3 participants |
| TAK-079 0.6 mg/kg SC | Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | 1 participants |
Secondary
AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-079
Time frame: Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose
Population: The PK analysis set included all participants who received study drug and had at least 1 measurable serum concentration of TAK-079. PK analysis was performed for TAK-079 0.6 mg/kg SC dose groups only, since serum concentrations of TAK-079 were below the LLOQ at all PK sampling time-points for remaining arms.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-079 0.6 mg/kg SC | AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-079 | 212 ng*day/mL | Standard Deviation 103 |
Secondary
AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079
Time frame: Day 1 pre-dose and at multiple time points (up to Day 78) post-dose
Population: The PK analysis set:all participants who received study drug and had at least 1 measurable serum concentration of TAK-079.A valid AUClast was derived for TAK-079 0.6 mg/kgSC dose group only, since serum concentrations of TAK-079 were either below the LLOQ at all PK sampling time-points or too limited to estimate AUClast reliably for remaining arms.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-079 0.6 mg/kg SC | AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079 | 90.4 nanogram*day per milliliter (ng*day/mL) | Standard Deviation 83.2 |
Secondary
Cmax: Maximum Observed Serum Concentration for TAK-079
Time frame: Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose
Population: The pharmacokinetic(PK) analysis set included all participants who received study drug and had at least 1 measurable serum concentration of TAK-079. PK analysis was performed for TAK-079 0.03, 0.06 mg/kg IV and 0.6 SC mg/kg dose groups only, since serum concentrations of TAK-079 were below the LLOQ at all PK sampling time-points for remaining arms.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAK-079 0.03 mg/kg IV | Cmax: Maximum Observed Serum Concentration for TAK-079 | 21.4 nanogram per milliliter (ng/mL) | Standard Deviation 8.3 |
| TAK-079 0.06 mg/kg IV | Cmax: Maximum Observed Serum Concentration for TAK-079 | 100.4 nanogram per milliliter (ng/mL) | Standard Deviation 51.7 |
| TAK-079 0.6 mg/kg SC | Cmax: Maximum Observed Serum Concentration for TAK-079 | 23.0 nanogram per milliliter (ng/mL) | Standard Deviation 15.5 |
Secondary
Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)
Results for ADA analysis were reported.
Time frame: Baseline up to Day 78
Population: The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits. Due to change in planned analysis testing of NAb activity of ADA positive samples was not analysed.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| TAK-079 Pooled Placebo IV | Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) | 0 percentage of participants | — |
| TAK-079 0.0003 mg/kg IV | Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) | 0 percentage of participants | — |
| TAK-079 0.001 mg/kg IV | Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) | 0 percentage of participants | — |
| TAK-079 0.003 mg/kg IV | Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) | 0 percentage of participants | — |
| TAK-079 0.01 mg/kg IV | Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) | 0 percentage of participants | — |
| TAK-079 0.03 mg/kg IV | Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) | 0 percentage of participants | — |
| TAK-079 0.06 mg/kg IV | Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) | 16.7 percentage of participants | — |
| TAK-079 Pooled Placebo SC | Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) | 0 percentage of participants | — |
| TAK-079 0.03 mg/kg SC | Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) | 33.3 percentage of participants | — |
| TAK-079 0.1 mg/kg SC | Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) | 16.7 percentage of participants | — |
| TAK-079 0.3 mg/kg SC | Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) | 0 percentage of participants | — |
| TAK-079 0.6 mg/kg SC | Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) | 16.7 percentage of participants | 102.58826 |