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

NCT03333928 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-10-23

Study results available
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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

DRUG

HTD1801

HTD1801 tablets, 250 mg

DRUG

Placebo

tablets manufactured to mimic HTD1801 tablets

Sponsors & Collaborators

  • HighTide Biopharma Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Adrian Di Bisceglie, MD,FACP,FAASLD · HighTide Therapeutics USA, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-09
Primary Completion
2020-04-30
Completion
2020-08-14
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03333928 on ClinicalTrials.gov