Autoimmune DiseasePhase 1NCT02219256

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

A Phase 1 study testing TAK-079 in people with Autoimmune Disease, run by Takeda at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 (SC) administration at escalating dose levels in healthy participants. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Autoimmune Disease
What is being tested?: TAK-079
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: 2 sitesUnited Kingdom
Study dates: Aug 2014to Apr 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

Study site
Headington, Oxford
Study site
London, London

Other trials in United Kingdom

About this study

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

Read the 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
Being tested: TAK-079, Placebo to TAK-079
Keywords: Drug therapy
Medical subject headings: Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-079Drug
TAK-079 solution
Placebo to TAK-079Drug
Placebo to TAK-079 solution

Study groups in NCT02219256
Study group	Role	What they receive
Cohort 1: TAK-079 0.0003 mg/kg	Experimental	TAK-079 0.0003 mg/kg, infusion, intravenously, once. Receives: 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) Receives: Drug: TAK-079
Placebo to TAK-079	Placebo comparator	Placebo to TAK-079, infusion, intravenously or subcutaneously, once. Receives: Drug: Placebo to TAK-079

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
Measured: 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
Measured: 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
Measured: First dose up to Day 78

Secondary outcomes (4)

Cmax: Maximum Observed Serum Concentration for TAK-079
Measured: 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
Measured: 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
Measured: 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)
Results for ADA analysis were reported.
Measured: Baseline up to Day 78

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Apr 2016

First posted18 Aug 2014 (estimated)
Study startAug 2014
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Autoimmune DiseaseStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02219256
Sponsor's protocol ID: TAK-079_101
Other IDs: U1111-1155-5857, 2013-004210-18, 14/LO/1070
Status last verified: Mar 2017
First submitted: 14 Aug 2014
Last updated: 3 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 32045493

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Autoimmune Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02219256
Acronym / sponsor ID: TAK-079_101
Conditions: Autoimmune Disease
Keywords: Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 18 Aug 2014 (estimated)
Results: Posted 3 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Cohort 1: TAK-079 0.0003 mg/kg	Experimental	Drug: TAK-079TAK-079 0.0003 mg/kg, infusion, intravenously, once.
Cohort 2-9: TAK-079 TBD	Experimental	Drug: TAK-079TAK-079, infusion, intravenously or subcutaneously, once. Dose to be determined from data collected in previous IV or SC Cohort(s)
Placebo to TAK-079	Placebo comparator	Drug: Placebo to TAK-079Placebo to TAK-079, infusion, intravenously or subcutaneously, once.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (8 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAK-079TAK-079 solution	Drug	Cohort 1: TAK-079 0.0003 mg/kg, Cohort 2-9: TAK-079 TBD
Placebo to TAK-079Placebo to TAK-079 solution	Drug	Placebo to TAK-079

Primary outcome

Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE)
Time frame: First dose up to Day 94
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
Time frame: 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
Time frame: 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
Time frame: First dose up to Day 78

4 secondary outcomes

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
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
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
Percentage of Participants With Positive Antidrug Antibody (ADA) and Neutralizing Antibody (Nab)
Time frame: Baseline up to Day 78

Results and safety

Results posted to the registry on 3 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TAK-079 Pooled Placebo IV	12	12
TAK-079 0.0003 mg/kg IV	4	4
TAK-079 0.001 mg/kg IV	4	4
TAK-079 0.003 mg/kg IV	4	4
TAK-079 0.01 mg/kg IV	6	6
TAK-079 0.03 mg/kg IV	6	6
TAK-079 0.06 mg/kg IV	6	6
TAK-079 Pooled Placebo SC	8	8
TAK-079 0.03 mg/kg SC	6	6
TAK-079 0.1 mg/kg SC	6	6
TAK-079 0.3 mg/kg SC	6	6
TAK-079 0.6 mg/kg SC	6	6

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

Time frame: First dose up to Day 94. Number. Unit: participants

Measure	TAK-079 Pooled Placebo IV n = 12	TAK-079 0.0003 mg/kg IV n = 4	TAK-079 0.001 mg/kg IV n = 4	TAK-079 0.003 mg/kg IV n = 4	TAK-079 0.01 mg/kg IV n = 6	TAK-079 0.03 mg/kg IV n = 6	TAK-079 0.06 mg/kg IV n = 6	TAK-079 Pooled Placebo SC n = 8	TAK-079 0.03 mg/kg SC n = 6	TAK-079 0.1 mg/kg SC n = 6	TAK-079 0.3 mg/kg SC n = 6	TAK-079 0.6 mg/kg SC n = 6
TEAE: Mild	6	3	2	1	5	4	2	3	5	4	4	4
TEAE: Moderate	5	0	1	2	1	2	4	3	1	2	1	1
TEAE: Severe	0	0	0	0	0	0	0	0	0	0	0	0
SAE	0	0	0	0	0	0	0	0	0	0	0	0

Population analysed: The safety analysis set included all participants who were enrolled, received 1 dose of study drug (after study drug dosing started) inclusive of those participants who did not complete all scheduled study visits.

Primary outcome: 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. Number. Unit: participants

Measure	TAK-079 Pooled Placebo IV n = 12	TAK-079 0.0003 mg/kg IV n = 4	TAK-079 0.001 mg/kg IV n = 4	TAK-079 0.003 mg/kg IV n = 4	TAK-079 0.01 mg/kg IV n = 6	TAK-079 0.03 mg/kg IV n = 6	TAK-079 0.06 mg/kg IV n = 6	TAK-079 Pooled Placebo SC n = 8	TAK-079 0.03 mg/kg SC n = 6	TAK-079 0.1 mg/kg SC n = 6	TAK-079 0.3 mg/kg SC n = 6	TAK-079 0.6 mg/kg SC n = 6
Value	1	1	0	0	0	0	0	2	0	0	0	2

Primary outcome: 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. Number. Unit: participants

Measure	TAK-079 Pooled Placebo IV n = 12	TAK-079 0.0003 mg/kg IV n = 4	TAK-079 0.001 mg/kg IV n = 4	TAK-079 0.003 mg/kg IV n = 4	TAK-079 0.01 mg/kg IV n = 6	TAK-079 0.03 mg/kg IV n = 6	TAK-079 0.06 mg/kg IV n = 6	TAK-079 Pooled Placebo SC n = 8	TAK-079 0.03 mg/kg SC n = 6	TAK-079 0.1 mg/kg SC n = 6	TAK-079 0.3 mg/kg SC n = 6	TAK-079 0.6 mg/kg SC n = 6
Value	6	2	2	2	1	4	6	4	4	4	3	1

Primary outcome: 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. Number. Unit: participants

Measure	TAK-079 Pooled Placebo IV n = 12	TAK-079 0.0003 mg/kg IV n = 4	TAK-079 0.001 mg/kg IV n = 4	TAK-079 0.003 mg/kg IV n = 4	TAK-079 0.01 mg/kg IV n = 6	TAK-079 0.03 mg/kg IV n = 6	TAK-079 0.06 mg/kg IV n = 6	TAK-079 Pooled Placebo SC n = 8	TAK-079 0.03 mg/kg SC n = 6	TAK-079 0.1 mg/kg SC n = 6	TAK-079 0.3 mg/kg SC n = 6	TAK-079 0.6 mg/kg SC n = 6
Value	8	3	3	1	3	5	1	5	4	5	1	0

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 94 days after the last dose of double-blind study drug.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TAK-079 Pooled Placebo IV	0 of 12 (0%)	11 of 12 (91.7%)	Not reported
TAK-079 0.0003 mg/kg IV	0 of 4 (0%)	3 of 4 (75%)	Not reported
TAK-079 0.001 mg/kg IV	0 of 4 (0%)	3 of 4 (75%)	Not reported
TAK-079 0.003 mg/kg IV	0 of 4 (0%)	3 of 4 (75%)	Not reported
TAK-079 0.01 mg/kg IV	0 of 6 (0%)	6 of 6 (100%)	Not reported
TAK-079 0.03 mg/kg IV	0 of 6 (0%)	6 of 6 (100%)	Not reported
TAK-079 0.06 mg/kg IV	0 of 6 (0%)	6 of 6 (100%)	Not reported
TAK-079 Pooled Placebo SC	0 of 8 (0%)	6 of 8 (75%)	Not reported
TAK-079 0.03 mg/kg SC	0 of 6 (0%)	6 of 6 (100%)	Not reported
TAK-079 0.1 mg/kg SC	0 of 6 (0%)	6 of 6 (100%)	Not reported
TAK-079 0.3 mg/kg SC	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
TAK-079 0.6 mg/kg SC	0 of 6 (0%)	5 of 6 (83.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32045493Fedyk 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director Clinical Science study director

Takeda

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-079 in people with Autoimmune Disease, run by Takeda at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) and Serious Adverse Event (SAE) (time frame: First dose up to Day 94). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02219256, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.