NCT02219256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 3, 2017

Completed
Last Updated

May 3, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

August 14, 2014

Results QC Date

January 23, 2017

Last Update Submit

March 22, 2017

Conditions

Autoimmune Disease

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (4)

  • 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).

    First dose up to Day 94

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

    First dose up to Day 78

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

    First dose up to Day 78

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

    First dose up to Day 78

Secondary Outcomes (4)

  • Cmax: Maximum Observed Serum Concentration for TAK-079

    Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose

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

    Day 1 pre-dose and at multiple time points (up to Day 78) post-dose

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

    Day 1 pre-dose and at multiple time-points (up to Day 78) post-dose

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

    Baseline up to Day 78

Study Arms (3)

Cohort 1: TAK-079 0.0003 mg/kg

EXPERIMENTAL

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

Drug: TAK-079

Cohort 2-9: TAK-079 TBD

EXPERIMENTAL

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

Drug: TAK-079

Placebo to TAK-079

PLACEBO COMPARATOR

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

Drug: Placebo to TAK-079

Interventions

TAK-079DRUG

TAK-079 solution

Cohort 1: TAK-079 0.0003 mg/kgCohort 2-9: TAK-079 TBD
Placebo to TAK-079DRUG

Placebo to TAK-079 solution

Placebo to TAK-079

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

London, London, United Kingdom

Location

Unknown Facility

Headington, Oxford, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 32045493DERIVED

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Study Officials

  • Medical Director Clinical Science

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2014

First Posted

August 18, 2014

Study Start

August 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 3, 2017

Results First Posted

May 3, 2017

Record last verified: 2017-03

Locations

GB(2)