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

Autoimmune Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219256
• Other study ID #: TAK-079_101
• Secondary ID: U1111-1155-58572
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2014
• Last updated: June 20, 2016
• Start date: August 2015
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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 administration at escalating dose levels in healthy participants.

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 intravenous infusion. The starting dose will be 0.0003 mg/kg. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Is a healthy male or female with no child bearing potential who is 18 to 55 years of age inclusive.

2. 2. The subject weighs at least 70 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 kg/m2, 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Disease
• Autoimmune Diseases

Intervention

Drug:
• TAK-079
TAK-079 solution
• Placebo to TAK-079
Placebo to TAK-079 solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who experience at least 1 treatment-emergent adverse event	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. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.	Day 1 to the end of the study (up to Day 92)	Yes
Primary	Percentage of participants who meet the Takeda markedly abnormal criteria for safety laboratory tests at least once post-dose	The percentage of participants with any markedly abnormal, according to Takeda criteria, standard safety laboratory values, including hematology and serum chemistries during the study period.	Day 1 to the end of the study (up to Day 92)	Yes
Primary	Percentage of participants who meet the Takeda markedly abnormal criteria for vital sign measurements at least once post-dose	The percentage of participants with any markedly abnormal, according to Takeda criteria, vital signs, during the study period.	Day 1 to the end of the study (up to Day 92)	Yes
Primary	Percentage of participants who meet the Takeda markedly abnormal criteria for electrocardiogram measurements at least once post-dose	The percentage of participants with any markedly abnormal, according to Takeda criteria, electrocardiogram measurements during the study period.	Day 1 to the end of the study (up to Day 92)	Yes
Secondary	Cmax: Maximum Observed Serum Concentration for TAK-079	Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve.	Day 1 through Day 78	No
Secondary	AUC(0-tlqc): Area under the serum concentration-time curve from time 0 to the time of the last quantifiable concentration for TAK-079	AUC(0-tlqc) is a measure of total serum exposure to the drug from time 0 to time of the last quantifiable concentration.	Day 1 through Day 78	No
Secondary	Area under the serum concentration-time curve from time 0 to infinity AUC(0-inf) for TAK-079	AUC(0-inf) is a measure of total serum exposure to the drug from time 0 to infinity.	Day 1 through Day 78	No
Secondary	Proportion of participants who test positive for TAK-079 anti-drug antibody (ADA)		Pre-dose through Day 78	No
Secondary	Proportion of participants who test positive for TAK-079 neutralizing ADA (NAb)		Pre-dose through Day 78	No