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

NCT ID: NCT02219256

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-04-30

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.

Conditions

Autoimmune Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1: TAK-079 0.0003 mg/kg

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

Group Type: EXPERIMENTAL

TAK-079

Intervention Type: DRUG

TAK-079 solution

Cohort 2-9: TAK-079 TBD

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

Group Type: EXPERIMENTAL

TAK-079

Intervention Type: DRUG

TAK-079 solution

Placebo to TAK-079

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

Group Type: PLACEBO_COMPARATOR

Placebo to TAK-079

Intervention Type: DRUG

Placebo to TAK-079 solution

Interventions

TAK-079

TAK-079 solution

Intervention Type: DRUG

Placebo to TAK-079

Placebo to TAK-079 solution

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

London, London, United Kingdom

Headington, Oxford, United Kingdom

Countries

United Kingdom

References

Fedyk ER, Zhao L, Koch A, Smithson G, Estevam J, Chen G, Lahu G, Roepcke S, Lin J, Mclean L. Safety, tolerability, pharmacokinetics and pharmacodynamics of the anti-CD38 cytolytic antibody TAK-079 in healthy subjects. Br J Clin Pharmacol. 2020 Jul;86(7):1314-1325. doi: 10.1111/bcp.14241. Epub 2020 Feb 22.

Reference Type: DERIVED

PMID: 32045493 (View on PubMed)

Other Identifiers

U1111-1155-5857

Identifier Type: REGISTRY

Identifier Source: secondary_id

2013-004210-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

14/LO/1070

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-079_101

Identifier Type: -

Identifier Source: org_study_id