TAK-004 for Healthy Adults
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and antidrug antibody status.
Treatment Details
Interventions
- TAK-004
Find a Clinic Near You
Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
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