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

NCT06281704 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

Interventions

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 .

Sponsors & Collaborators

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
2020-11-26
Primary Completion
2022-05-17
Completion
2022-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT06281704 on ClinicalTrials.gov