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A Phase 1b Study to Evaluate APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis

NCT05743010 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-09-06

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, phase 1b study designed to evaluate safety, tolerability, PK, and preliminary efficacy of APL-1401 in patients with moderately to severely active UC. This study comprises 3 periods including screening period (D-28\~D-1), treatment period (D1-D28), and safety follow-up period(D29-D58).

Conditions

Interventions

DRUG

APL-1401

APL-1401 capsules orally once daily

DRUG

Placebo

Placebo capsules orally once daily

Sponsors & Collaborators

  • Jiangsu Yahong Meditech Co., Ltd aka Asieris

    lead INDUSTRY

Principal Investigators

  • Qiuyue QU · Jiangsu Yahong Meditech Co., Ltd aka Asieris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-01-26
Primary Completion
2025-03-31
Completion
2025-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05743010 on ClinicalTrials.gov