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APL-1401 for Ulcerative Colitis

Verified Trial
Phase 1
Recruiting
Research Sponsored by Jiangsu Yahong Meditech Co., Ltd aka Asieris
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are you between 18-65 years of age?
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 28
Awards & highlights

Study Summary

This trial tests a new drug to treat ulcerative colitis, monitored for safety, side effects, and effectiveness.

Who is the study for?
Adults aged 18-65 with moderately to severely active Ulcerative Colitis (UC) can join this trial. They must have a UC diagnosis for at least 3 months, a Total Mayo Score of 6-12, and be on stable doses of certain medications. Women must test negative for pregnancy and use two birth control methods; men also need to follow specific contraception guidelines.Check my eligibility
What is being tested?
APL-1401 is being tested against a placebo in this study. Participants will randomly receive either the drug or placebo without knowing which one they're getting. The trial includes initial screening, treatment over four weeks, and follows up safety checks until day 58.See study design
What are the potential side effects?
While the side effects of APL-1401 are not detailed here, typical side effects in such trials may include digestive issues like nausea or diarrhea, potential allergic reactions, fatigue, headaches, and possibly increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants adverse events (AEs)
Number of Participants adverse events of special interest (AESI)
Number of Participants serious adverse events (SAEs)
Secondary outcome measures
AUC
AUC0-24
AUClast
+11 more
Other outcome measures
CRP
ESR
Fecal calprotectin
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: APL-1401Experimental Treatment1 Intervention
On Day 1, patients will be randomized to receive either APL-1401 or placebo in a 5:1 ratio. Patients will receive APL-1401 orally once daily (QD) during the 28-day treatment period.
Group II: PlaceboPlacebo Group1 Intervention
Identically matching placebo capsules once daily for 28 days

Find a Location

Who is running the clinical trial?

Jiangsu Yahong Meditech Co., Ltd aka AsierisLead Sponsor
6 Previous Clinical Trials
1,485 Total Patients Enrolled
Qiuyue QUStudy DirectorJiangsu Yahong Meditech Co., Ltd aka Asieris

Media Library

APL-1401 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05743010 — Phase 1
Ulcerative Colitis Research Study Groups: APL-1401, Placebo
Ulcerative Colitis Clinical Trial 2023: APL-1401 Highlights & Side Effects. Trial Name: NCT05743010 — Phase 1
APL-1401 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05743010 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any restrictions in terms of age for joining this investigation?

"As outlined in the study's eligibility requirements, only individuals aged 18 to 65 may take part."

Answered by AI

Has the FDA approved APL-1401 for public consumption?

"APL-1401 has not yet been extensively tested, thus it is given a score of 1. This phase one trial does provide some insights into safety and efficacy but more testing will be necessary for further research."

Answered by AI

Are there any opportunities remaining to join this investigation?

"As indicated on clinicaltrials.gov, this medical endeavour is not currently capturing participants; however, it was initially posted in February of 2023 and recently updated a couple weeks later. Although the recruitment process has ceased, there are 410 other trials that are actively recruiting right now."

Answered by AI

Is there a way I can take part in this clinical research?

"This clinical trial is enrolling 36 individuals aged between 18 and 65 with ulcerative colitis. To qualify, they must meet the following conditions: have a rectal bleeding score ≥1 and a stool frequency Score ≥1 in addition to MESS ≥2; currently possess active UC as proven by Total Mayo Score 6-12 (inclusive) at baseline with corresponding MESS level; be taking oral 5-ammonosahcylate class of medications such as mesalamine, olsalazine, balsalazide, sulfasalazine for 4 weeks prior to randomization and maintain dosage throughout study period; women"

Answered by AI

What results are investigators hoping to attain with this research?

"This 30-day trial will primarily focus on the incidence of any serious adverse events (SAEs). Additionally, secondary objectives include measuring Tmax, T1/2 and AUClast values."

Answered by AI

Who else is applying?

What site did they apply to?
Other
Tandem Clinical Research - Houma, LA
Tandem Clinical Research - Metairie, LA
Tandem Clinical Research, Marrero
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I’d like to find a cure. I'm looking for a solution to not take medication or lower my doses.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Tandem Clinical Research, Marrero: < 48 hours
  2. Tandem Clinical Research - Metairie, LA: < 48 hours
  3. Tandem Clinical Research - Houma, LA: < 48 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Phase 1b Study to Evaluate APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis
2023. "A Phase 1b Study to Evaluate APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05743010.
All > Tandem > Ulcerative Colitis
~14 spots leftby Mar 2025
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