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

Primary Purpose

Autoimmune Disease

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

TAK-079

Placebo to TAK-079

About this trial

This is an interventional treatment trial for Autoimmune Disease focused on measuring Drug therapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Cohort 1: TAK-079 0.0003 mg/kg

Cohort 2-9: TAK-079 TBD

Placebo to TAK-079

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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).

Number of Participants Who Meet the Takeda Development Centre (TDC) Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose

Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose

Number of Participants Who Meet the TDC Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose

Secondary Outcome Measures

Cmax: Maximum Observed Serum Concentration for TAK-079

AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079

AUC∞: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-079

Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)

Results for ADA analysis were reported.

Full Information

NCT ID

NCT02219256

First Posted

August 14, 2014

Last Updated

March 22, 2017

Sponsor

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT02219256

Brief Title

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

Official Title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single Intravenous Infusion and Subcutaneous Administration of TAK-079 in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Takeda

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune Disease

Keywords

Drug therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1: TAK-079 0.0003 mg/kg

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 2-9: TAK-079 TBD

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo to TAK-079

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

TAK-079

Intervention Description

TAK-079 solution

Intervention Type

Drug

Intervention Name(s)

Placebo to TAK-079

Intervention Description

Placebo to TAK-079 solution

Primary Outcome Measure Information:

Title

Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)

Description

Time Frame

First dose up to Day 94

Title

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

Title

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

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)

Description

Results for ADA analysis were reported.

Time Frame

Baseline up to Day 78

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director Clinical Science

Organizational Affiliation

Takeda

Official's Role

Study Director

Facility Information:

City

Headington

State/Province

Oxford

Country

United Kingdom

City

London

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

32045493

Citation

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.

Results Reference

derived

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

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