Phase 1
Completed N=74
A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of TAK-079 in Healthy Participants
Source: ClinicalTrials.gov NCT02219256 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) — 6; 3; 2; 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) |
6; 3; 2; 1; 5; 4 | — |
| PRIMARY Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose |
1; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose |
6; 2; 2; 2; 1; 4 | — |
| PRIMARY Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose |
8; 3; 3; 1; 3; 5 | — |
| SECONDARY Cmax: Maximum Observed Serum Concentration for TAK-079 |
21.4; 100.4; 23.0 | — |
| SECONDARY AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079 |
90.4 | — |
| SECONDARY AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-079 |
212 | — |
| SECONDARY Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab) |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Is a healthy male or female with no child bearing potential who is 18 to 55 years of age inclusive.
- 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.
- 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
- 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).
- 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.
- Has received any other biologic medical products at any time in the past.
- Has a positive drug or alcohol screening result, or a history of drug or alcohol abuse.
- Has a positive test result for hepatitis or human immunodeficiency virus antibody.
- Has any signs of an acute infection or history of frequent or chronic infection, or herpes zoster.
- Has active or latent tuberculosis (TB)
- Considered unfit for the study by the Principal Investigator.
Data sourced from ClinicalTrials.gov (NCT02219256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.