A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of TAK-079 in Healthy Participants

Takeda

Status and phase: Completed; Phase 1

Conditions: Autoimmune Disease

Treatments: Drug: Placebo to TAK-079; Drug: TAK-079

Study type: Interventional

Funder types: Industry

Identifiers

NCT02219256

TAK-079_101

2013-004210-18 (EudraCT Number)

14/LO/1070 (Registry Identifier)

U1111-1155-5857 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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74 participants in 3 patient groups, including a placebo group

Cohort 1: TAK-079 0.0003 mg/kg

Experimental group

Description:

TAK-079 0.0003 mg/kg, infusion, intravenously, once.

Treatment:

Drug: TAK-079

Cohort 2-9: TAK-079 TBD

Experimental group

Description:

TAK-079, infusion, intravenously or subcutaneously, once. Dose to be determined from data collected in previous IV or SC Cohort(s)

Treatment:

Drug: TAK-079

Placebo to TAK-079

Placebo Comparator group

Description:

Placebo to TAK-079, infusion, intravenously or subcutaneously, once.

Treatment:

Drug: Placebo to TAK-079