NCT06281704

A Study of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis

A Phase Ib Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of Single and Multiple Administration of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and efficacy of AK101 in subjects with moderately to severely active ulcerative colitis.

Detailed description

This is a phase Ib, randomized, double-blind, placebo-controlled, dose-escalation, two-phase study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AK101 in subjects with moderately to severely active ulcerative colitis. The study consists of two parts. Part 1 is single-ascending-dose induction phase study, and Part 2 is a multiple subcutaneous maintenance therapy study followed by a single-dose induction treatment.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
BIOLOGICAL	AK101 IV	AK101 will be administered intravenously.
BIOLOGICAL	AK101 SC	AK101 will be administered subcutaneously.
BIOLOGICAL	Placebo	Placebo will be administered subcutaneously or intravenously.
BIOLOGICAL	AK101 IV/AK101 SC	AK101 will be administered as intravenous infusion at Week8, then subcutaneously every 8 weeks thereafter .

Timeline

• Start date: 2020-11-26
• Primary completion: 2022-05-17
• Completion: 2022-12-31
• First posted: 2024-02-28
• Last updated: 2024-02-28

Locations

12 sites across 1 country: China