TAK-004 for Healthy Adults

Overseen By Takeda Contact

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Takeda

Must not be taking: Herbal medicines

Disqualifiers: Alcoholism, Drug abuse, Cardiovascular, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

240 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires participants to refrain from using any medications, including herbal medicines, starting about 7 days before the first dose of the study drug.

What is the purpose of this trial?

This study is the first study with TAK-004 conducted in human beings. Participants will receive either TAK-004 or placebo. The main aim of this study is to learn how safe TAK-004 is in healthy adults and how well participants tolerate one or more doses of TAK-004. Other aims are to learn about the effects of TAK-004 on the heart rate and blood pressure and if TAK-004 creates an immune response (immunogenicity). Another aim is to learn how the body of healthy adults affects TAK-004 (pharmacokinetics). Participants will receive TAK-004 or placebo via injection just under the skin (subcutaneous injection or SC injection). Depending on the groups participants are assigned to, they will either receive just one dose of TAK-004 or placebo or multiple doses of TAK-004 or placebo while they are in the study. Blood and urine samples will be taken during the study.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

This trial is for healthy adults aged 18-55 who don't smoke or use nicotine/tobacco, haven't used cannabis frequently in the last 3 months, and have a BMI of 18-30 kg/m^2. Men must agree to use contraception and not donate sperm during the study. Women must be nonchildbearing potential or postmenopausal.

Inclusion Criteria

I understand the study procedures and agree to participate by providing written consent.

I am willing and able to follow all study procedures and rules during my stay in the research unit.

I am in good health with no history of psychiatric, liver, kidney, lung, or heart diseases.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Part 1: Single Ascending Dose

Participants receive a single subcutaneous injection of TAK-004 or placebo in a double-blind manner. Safety and tolerability data are reviewed up to 24 hours post-dose.

1 day

1 visit (in-person)

Treatment - Part 2: Multiple Ascending Dose

Participants receive daily subcutaneous injections of TAK-004 or placebo for 5 days. Doses are determined based on safety and PK data from Part 1.

5 days

5 visits (in-person)

Treatment - Part 3: Expansion Cohorts

Participants receive a single subcutaneous injection of TAK-004 or placebo. Doses are determined based on safety and PK data from Parts 1 and 2. Expansion cohort 2 is optional.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and antidrug antibody status.

60 days

Treatment Details

Interventions

• TAK-004

Trial Overview The trial tests TAK-004's safety and how well it's tolerated when given as an injection under the skin. It will also look at its effects on heart rate, blood pressure, immune response (immunogenicity), and how it's processed by the body (pharmacokinetics).

Participant Groups

Group I: Part 3: TAK-004 or Placebo (Expansion Cohorts) Experimental Treatment 2 Interventions

Participants will receive TAK-004 (TBD) or matching-placebo subcutaneous injection on Day 1 in each single ascending dose expansion cohorts (E1 and E2). Doses will be determined at the dose escalation meeting based on safety, tolerability and available PK data from Parts 1 and 2. Expansion cohort 2 (optional) may be conducted at the sponsor's discretion after reviewing expansion cohort 1 data.

Group II: Part 2: TAK-004 or Placebo (Multiple Ascending Dose Cohorts) Experimental Treatment 2 Interventions

Participants will receive TAK-004 (dose to be decided \[TBD\]) or matching-placebo subcutaneous injection, once daily for 5 days (i.e., Day 1 to 5) in each 5 multi-ascending dose cohorts (M1-M5). The dose in Part 2 will be determined at the dose escalation meeting based upon emerging safety, tolerability, and available PK data from Part 1.

Group III: Part 1: TAK-004 or Placebo (Single Ascending Dose Cohorts) Experimental Treatment 2 Interventions

Participants will receive TAK-004 or matching-placebo subcutaneous injection on Day 1 in Cohort S1 using a sentinel dosing scheme in a double-blind manner. After dosing the first two participants in Cohort S1, the investigator will review all available safety and tolerability data up to 24 hours post-dose before dosing the remaining participants in the Cohort S2-S10. Single ascending doses are nominal and may be modified based on emerging safety and available PK data during the study but will have a corresponding dose that does not exceed the maximal defined exposure.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Takeda Development Center Americas, Inc.

Industry Sponsor

Trials

58

Recruited

10,800+