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

NCT06236009 | Completed Phase 1 FDA Drug

• 1 other identifier: TAK-004-1001
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study investigational product (IP), whether or not the occurrence is considered related to the study IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study IP. An untoward finding generally may necessitate therapeutic intervention, require an invasive diagnostic procedure, or require discontinuation or a change in dose of IP or a concomitant medication. Any clinically significant vital signs, electrocardiogram (ECG)/telemetry/Holter monitoring, laboratory values will be considered as AEs.

  From the first dose of study drug up to 60 days

Secondary Outcomes (19)

• Orthostatic Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Values From Semi-Recumbent to Standing at 0.5 Hours After First Dose

  From semi-recumbent to standing at 0.5 hours after first dose (Day 1)

• Changes in Semi-Recumbent Heart Rate (HR) Values at 2 Hours After First Dose

  At 2 hours after first dose (Day 1)

• Number of Participants with Antidrug Antibody (ADA) Status

  From the first dose of study drug up to 60 days

• Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax ) for TAK-004

  Part 1: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 5, 7, 10, 14, 24, 30, 48, 72 and 96 hours post-dose; Part 2: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 5, 7, 10, 14, and 24 hours at Days 1 and 5 post-dose

• Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) for TAK-004

  Part 1: Pre-dose (Day 1), 0.25, 0.5, 1, 2, 3, 4, 5, 7, 10, 14, 24, 30, 48, 72 and 96 hours post-dose

Study Arms (3)

Part 1: TAK-004 or Placebo (Single Ascending Dose Cohorts)

EXPERIMENTAL

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.

Drug: TAK-004; Drug: Placebo

Part 2: TAK-004 or Placebo (Multiple Ascending Dose Cohorts)

EXPERIMENTAL

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.

Drug: TAK-004; Drug: Placebo

Part 3: TAK-004 or Placebo (Expansion Cohorts)

EXPERIMENTAL

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.

Drug: TAK-004; Drug: Placebo

Interventions

TAK-004 DRUG

TAK-004 subcutaneous injections.

Part 1: TAK-004 or Placebo (Single Ascending Dose Cohorts); Part 2: TAK-004 or Placebo (Multiple Ascending Dose Cohorts); Part 3: TAK-004 or Placebo (Expansion Cohorts)

Placebo DRUG

Matching- placebo subcutaneous injections.

Part 1: TAK-004 or Placebo (Single Ascending Dose Cohorts); Part 2: TAK-004 or Placebo (Multiple Ascending Dose Cohorts); Part 3: TAK-004 or Placebo (Expansion Cohorts)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To be eligible for participation in this study, the participant must:
• Understand the study procedures and agree to participate by providing written informed consent.
• Be willing and able to comply with all study procedures and restrictions and follow all rules and regulations while confined in the clinical research unit.
• Be a healthy male or woman of nonchildbearing potential (WONCBP) participant aged 18 to 55 years, inclusive, at the screening visit.
• Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at least 3 months before dosing.
• Has not had frequent or heavy use (i.e., near-daily) of medical or recreational cannabis for at least 3 months before screening.
• Has a body mass index greater than or equal to (\>=) 18 and less than or equal to (\<=) 30.0 kilogram per square meter (kg/m\^2) at the screening visit.
• Be judged to be in good health (example, no evidence of psychiatric, hepatic, renal, pulmonary, or cardiovascular disease) by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, ECG, and vital sign measurements performed at the screening visit and before administration of the initial dose of IP or invasive procedure.
• Meet the following birth control requirements:
• Is a male participant who is sterile or agrees to use an appropriate method of contraception, including a condom with or without spermicidal cream or jelly, from the first dose of IP until 5 half-lives after the last dose of IP. No restrictions are required for a vasectomized male participant provided the participant is at least 4 months after bilateral vasectomy procedure before the first dose of IP. A male participant whose vasectomy procedure was performed less than 4 months before the first dose of IP must follow the same restrictions as a non-vasectomized man. Appropriate documentation of surgical procedure should be provided.
• Is a male participant who agrees not to donate sperm from the first dose of IP until 5 half-lives after the last dose of IP.
• Is a WONCBP, defined by at least 1 of the following criteria:
• Postmenopausal (defined as 12 months of spontaneous amenorrhea in females aged greater than (\>) 45 years or 6 months of spontaneous amenorrhea in females aged \>45 years with serum follicle-stimulating hormone (FSH) levels \>40 milli-international units per milliliter \[mIU/mL\]). Appropriate documentation of FSH levels is required.
• Surgically sterile by hysterectomy and/or bilateral oophorectomy with appropriate documentation of surgical procedure.
• Had a bilateral tubal ligation, bilateral tubal occlusion, or bilateral salpingectomy with appropriate documentation of surgical procedure.

You may not qualify if:

• Any participant who meets any of the following criteria will not qualify for entry into the study:
• The participant has participated in another investigational study within 4 weeks (or based on local regulations) or within 5 half-lives of the IP before the day of check-in. The 4-week or 5 half-lives window will be derived from the date of the last IP administration and/or AE related to the IP administration in the previous study to the day of check-in of the current study.
• The participant is an employee of the sponsor or study site or immediate family member (example, spouse, parent, child, sibling) of the sponsor or study site.
• The participant has a history of significant multiple and/or severe allergies (example, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food. A history of mild seasonal allergies/allergic rhinitis is allowed at the investigator's discretion.
• The participant has a known hypersensitivity or contraindication to any component of TAK-004.
• The participant has a positive pregnancy test result or is lactating or breastfeeding.
• The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency antibody/antigen, at the screening visit.
• The participant had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks before the screening visit.
• The participant is unable to refrain from or anticipates using medications including herbal medicines beginning approximately 7 days before administration of the first dose of IP.
• The participant is unable to refrain from or anticipates using marijuana or cannabis-containing products from screening, through check-in (Day -2) or within 15 days of drug administration (whichever is longer).
• The participant has a history or presence of alcoholism or drug abuse within the past 2 years before dosing.
• The participant drinks alcohol in excess of 21 glasses/units per week for males or 14 glasses/units per week for females, with one unit = 150 mL of wine or 360 mL of beer or 45 mL of 45% alcohol.
• Positive alcohol test result at check in, or positive urine drug screen results at screening or check-in.
• The participant has a history of major psychotic disorder.
• The participant has a history or presence of:

Sponsors & Collaborators

• Takeda: lead
• Takeda Development Center Americas, Inc.: collaborator

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: November 1, 2024
• Primary Completion: October 17, 2025
• Study Completion: October 17, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (1)