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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and tolerability of a new treatment called TAK-004 in healthy individuals. Participants will receive either TAK-004 or a placebo through subcutaneous injections. The trial will also evaluate TAK-004's effects on heart rate, blood pressure, and its potential to trigger an immune response. It seeks healthy adults who do not smoke or use cannabis regularly and have no history of major health issues like heart or kidney disease. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

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.

Is there any evidence suggesting that TAK-004 is likely to be safe for humans?

A previous study tested TAK-004 in humans for the first time. The main goal was to assess its safety and tolerability. As this was early research, specific information about its safety in humans was not yet available. This study marked the initial step in testing TAK-004 in people, focusing primarily on ensuring the treatment does not cause significant harm before proceeding to more detailed testing. Participants received either a single dose or multiple doses, with close monitoring to quickly identify any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

TAK-004 is unique because it is designed to be administered as a subcutaneous injection, offering a potentially more convenient delivery method compared to traditional oral or intravenous treatments. Researchers are excited about TAK-004 because it involves a novel dosing strategy with both single and multiple ascending doses, allowing for precise adjustments based on safety and tolerability data. This adaptability could lead to more personalized treatment plans, optimizing dose levels to maximize efficacy and minimize side effects.

What evidence suggests that TAK-004 could be effective?

Researchers are testing TAK-004 in humans for the first time, so its effectiveness remains unknown. This study aims to understand how TAK-004 acts in the body and to assess its safety. Participants will receive injections just under the skin, either of TAK-004 or a placebo, across different study parts. Researchers are also examining its effects on heart rate and blood pressure and whether it causes an immune response. Although solid evidence of its effectiveness is not yet available, understanding these factors will help assess its potential as a future treatment. ^{1 2 3 6 7}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06236009

NCT06236009 | A First-In-Human Study of TAK-004 in ... 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 ...

2. clinicaltrials.takeda.com clinicaltrials.takeda.com/study-detail/256f8c1e888a4fef?

A First-In-Human Study of TAK-004 in Healthy Adults 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 ...

3. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-2-2024-80429

TAK-004 for Healthy Adults · Info for Participants 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10739571/

A Phase 1 Open-Label Study to Assess the Tolerability ... Hyaluronidase-facilitated subcutaneous immunoglobulin 20% (fSCIG 20%, also known as TAK-881) is an infusion of IgG 20% and rHuPH20. The ratio of ...

5. cidrap.umn.edu cidrap.umn.edu/dengue/trial-data-highlight-sustained-protection-dengue-vaccine

Trial data highlight sustained protection from dengue vaccine The trial involved more than 20,000 healthy children and adolescents (aged 4 to 16 years) from eight dengue-endemic countries in Latin America.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12560204/

Adverse Events and Immunization Errors Following a Mass ... 4. Discussion. The study confirms that the Qdenga® vaccine (TAK‐003) has a favorable safety profile, with most AEs being mild and transient in ...

7. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/takeda-tides-trial-confirms-long-term-efficacy-safety-qdenga-dengue-vaccine

Takeda's Phase III TIDES Trial Confirms Long-Term ... Seven-year results from the global TIDES study show sustained protection, strong safety, and enhanced efficacy with a booster dose, ...