Actively Recruiting
A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)
Led by Takeda · Updated on 2026-03-05
134
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 68 years at the time of consent
- Willing and able to comply with all trial procedures
- Provided informed consent before starting trial procedures
- For Phase 1a: Healthy with no significant cardiovascular, liver, metabolic, gastrointestinal, or kidney disease
- Body mass index (BMI) less than 30 kg/m2 at screening
- No frequent or heavy use of cannabis for at least 3 months before screening
- Not a person of childbearing potential (surgically sterile, postmenopausal, or no uterus)
- Males must use highly effective contraception during and for 6 months after the trial
- For Phase 1b: Confirmed diagnosis of large-duct PSC by at least two specific criteria
- Fibrogenesis biomarker above a pre-defined level
- Evidence of moderate to advanced fibrosis but no cirrhosis
- No cholangiocarcinoma or other malignancy on MRI at screening
- Able to understand and comply with subcutaneous administration procedures
- Use of highly effective contraception for persons of childbearing potential during and for 6 months after the trial
You will not qualify if you...
- Employees or immediate family members of sponsor or trial site involved in the trial
- Known hypersensitivity to TAK-781 or related compounds
- History of severe allergies or anaphylaxis to drugs or food
- History or evidence of bleeding or coagulation disorders
- History of gallbladder removal
- Participation in another investigational trial within 4 weeks or 5 half-lives prior to screening
- Elevated liver enzymes (ALT or AST) above upper limit of normal
- Abnormal cholesterol or triglyceride levels at screening
- Reduced kidney function (eGFR ≤90 mL/min/1.73m²)
- Abnormal ECG or heart rhythm disorders
- High blood pressure or heart rate outside defined ranges
- Positive drug abuse screen or recent drug/alcohol abuse
- Recent major surgery or blood donation within 4 weeks
- Positive pregnancy test during screening
- Positive tests for hepatitis B DNA, hepatitis C RNA, or HIV infection
- Current illness interfering with trial participation
- Inability to refrain from prohibited medications, substances, or smoking during trial
- History of malignancy within 5 years
- Evidence or history of cirrhosis or decompensated liver disease
- Presence of secondary sclerosing cholangitis or related liver conditions
- Dominant bile duct strictures or recent bile duct interventions
- Prior liver transplantation
- Use of prohibited medications or investigational treatments within restricted periods
- Severe allergic reactions to components of similar RNA therapeutics
- Clinically significant unstable or untreated illnesses
- Social or geographic conditions limiting trial participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
ICON
Salt Lake City, Utah, United States, 84124
Actively Recruiting
Research Team
T
Takeda Contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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