A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-68
SponsorTakeda
About this trial
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.
Eligibility criteria
Qualifiers
The participant is willing and able to fully comply with all trial procedures and requirements, in the investigator's opinion.
The participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) or electronic consent [e-consent] if applicable) and any required privacy authorization prior to the initiation of any trial procedures.
Male at birth and female at birth participants aged 18 to 68 years, inclusive, at the time of consent.
The participant is judged to be in good health (for example, no evidence of cardiovascular, liver, metabolic, gastroenterological, or kidney disease) by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, ECG, and vital sign measurements performed at the first screening visit.
Disqualifiers
The participant is an employee of the sponsor or trial site, or an immediate family member (for example, spouse, parent, child, sibling) of an employee of the sponsor or trial site who is directly involved in the conduct of the trial.
The participant has a known hypersensitivity to any component of the formulation of TAK-781 or related compounds.
The participant has a history of significant multiple and/or severe allergies (for example, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
The participant has a history or clinical evidence of bleeding diathesis or any coagulation disorder.
Trial design
Treatments tested in this trial
- TAK-781
- Placebo
Treatment groups
134 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov