A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Takeda
Study ID
NCT07229911
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteers
  • Primary Sclerosing Cholangitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 68 Years
Healthy Volunteers
Accepted

Interventions

  • TAK-781 — DRUG
    TAK-781 injection.
  • Placebo — DRUG
    TAK-781 matching placebo injection.

Study Details

The main aim of this study is to see if the drug TAK-781 is safe for healthy volunteers and for participants with PSC. The study will also look at how well participants can tolerate TAK-781. In addition, the study will check how the body absorbs, uses, and gets rid of TAK-781 (Pharmacokinetics \[PK\]), how the drug affects the body (Pharmacodynamics \[PD\]), and how the body's immune system reacts to TAK-781 (Immunogenicity). The study consists of two phases (Phase 1a and 1b). Phase 1a includes two parts: Part 1 (Single Ascending Dose \[SAD\]) and Part 2 (Multiple Ascending Dose \[MAD\]). In Part 1, healthy participants will receive either single dose of TAK-781 or a placebo. A placebo looks the same as TAK-781 but has no medicine in it. In Part 2, healthy participants will receive multiple doses of TAK-781 or a placebo. In Phase 1b (Part 3), participants with large duct, non-cirrhotic PSC will receive a single dose of TAK-781. Participants will be in the study for about 36 weeks.

Key Dates

Start date
Jan 7, 2026
Status verified
Mar 2026
Primary completion
Apr 6, 2028
Completion
Apr 6, 2028

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a (Part 1): TAK-781 SAD
    Healthy participants will receive a single dose of TAK-781 injection at different dose level cohorts (1-6) on Day 1 of the pre-defined treatment period. An additional cohort may be added to repeat a selected dose from one of the previously tested dose levels in order to assess safety and tolerability and/or to verify the level of target engagement (TE).
  • Placebo Comparator: Phase 1a (Part 1): Placebo SAD
    Healthy participants will receive TAK-781 matching placebo injection on Day 1 of the pre-defined treatment period.
  • Experimental: Phase 1a (Part 2): TAK-781 MAD
    Healthy participants will receive multiple doses of TAK-781 injection across five cohorts (1 to 5), with or without a loading dose during the pre-defined treatment period. An additional cohort may be added to repeat a selected dose level and/or dosing regimen from one of the previously tested dose levels and/or dosing regimens in order to assess safety and tolerability, and/or to verify the level of TE.
  • Placebo Comparator: Phase 1a (Part 2): Placebo MAD
    Healthy participants will receive multiple doses of TAK-781 matching placebo injection, with or without a loading dose during the pre-defined treatment period.
  • Experimental: Phase 1b (Part 3): TAK-781
    Participants with non-cirrhotic PSC will receive a single dose of TAK-781 injection on Day 1 during the pre-defined treatment period. Part 3 will not begin until the SAD portion of the trial is considered complete.

Primary Outcome Measure

Phase 1a (SAD and MAD) and Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Phase 1a (SAD) and 1b: From start of study drug administration up to End of Treatment (EOT)/Early termination (ET) (up to Week 20); Phase 1a (MAD): From start of study drug administration up to EOT/ET (up to Week 32) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ICONSalt Lake CityUtah84124
Site Contact
801-269-8200
Matthew D. Johnston, MD (PRINCIPAL_INVESTIGATOR)

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ICON· Salt Lake City, UT

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