NCT03333928

A POC and Dose-Ranging Study of HTD1801 in PSC Patients

A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adult Subjects With Primary Sclerosing Cholangitis (PSC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: HighTide Biopharma Pty Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study was a dose-ranging, 18-week study comparing two doses of HTD1801 (500 mg BID and 1000 mg BID) to placebo in adult subjects with PSC.

Conditions

• Primary Sclerosing Cholangitis (PSC)

Interventions

Type	Name	Description
DRUG	HTD1801	HTD1801 tablets, 250 mg
DRUG	Placebo	tablets manufactured to mimic HTD1801 tablets

Timeline

• Start date: 2018-02-09
• Primary completion: 2020-04-30
• Completion: 2020-08-14
• First posted: 2017-11-07
• Last updated: 2025-10-23
• Results posted: 2022-04-06

Locations

26 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study