Conditions: Autoimmune Disease
Keywords: Drug therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 74
Healthy volunteers: yes

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.

Arms:
arm 1: TAK-079 0.0003 mg/kg, infusion, intravenously, once. arm 2: TAK-079, infusion, intravenously or subcutaneously, once. Dose to be determined from data collected in previous IV or SC Cohort(s) arm 3: Placebo to TAK-079, infusion, intravenously or subcutaneously, once.

Interventions: intervention 1: TAK-079 intervention 2: Placebo to TAK-079
Intervention descriptions: intervention 1: TAK-079 solution intervention 2: Placebo to TAK-079 solution

Protocol document: