Ulcerative Colitis (UC)Phase 1NCT07744646
Alpha-0261 Tablets for Moderate-to-Severe Ulcerative Colitis
A Phase 1 study testing Alpha-0261 in people with Ulcerative Colitis (UC), run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
Trial summary
The purpose of this protocol is to evaluate the safety and efficacy of Alpha-0261 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that Alpha-0261 is safe, and the secondary hypothesis is that Alpha-0261 is effective, as assessed by the proportion of participants… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- Alpha-0261
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2026to 20 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years (inclusive), male or female.
- Diagnosed with ulcerative colitis at least 3 months prior to screening; this diagnosis must be confirmed by endoscopy or histology.
- Patients must have moderate-to-severe active ulcerative colitis, as defined by an mMS score of 4 to 9 (blood in stool subscore ≥ 1, frequency of bowel ovements subscore ≥ 1, and colonoscopy subscore ≥ 2 [as confirmed by the study site's image reviewer]; the sum of these three subscores must be at least 4).
- The investigator determines that the participant has had an inadequate response to or is intolerant of at least one conventional therapy aminosalicylates, corticosteroids, or immunosuppressants) or a biologic agent (anti-TNF-α, anti-α4β7 integrin, or anti-IL-12/23 antibodies, etc.).
- Voluntarily sign the informed consent form and be willing to comply with the study procedures and complete the trial in accordance with the protocol.
Who cannot join
- Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment
- Has a current diagnosis of fulminant colitis and/or toxic megacolon
- Has UC limited to the rectum
- Has a history of or is anticipated to require surgical intervention for ulcerative colitis during the study, including but not limited to ostomy, ileal pouch-anal anastomosis, and intestinal resection.
- Has any active infection as specified in the protocol
- Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
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- Has evidence of active tuberculosis (TB) or meets TB exclusionary parameters
- Has a history of cancer (except fully treated nonmelanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for <5 years before Randomization
- Has had major surgery within 4 weeks before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study
- Has received protocol-specified prohibited medications
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
Guifang Xu
About this study
Official title: An Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Alpha-0261 Tablets in Patients With Moderate to Severe Active Ulcerative Colitis (UC)
The purpose of this protocol is to evaluate the safety and efficacy of Alpha-0261 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that Alpha-0261 is safe, and the secondary hypothesis is that Alpha-0261 is effective, as assessed by the proportion of participants achieving clinical remission per the complete modified Mayo score at Week 10.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Alpha-0261
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-0261Drug
Drug: Alpha-0261 Oral, tablet
| Study group | Role | What they receive |
|---|---|---|
| Alpha-0261 | Experimental | Participants will take Alpha-0261 tablets orally once daily for 10 consecutive weeks. Receives: Drug: Alpha-0261 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Safety endpoints: These include, but are not limited to, adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examinations, 12-lead electrocardiograms (ECGs), and clinical laboratory tests (complete blood count, urinalysis, blood chemistry, and coagulation tests).
Measured: From enrollment to the end of study at 12 weeks.
Secondary outcomes (1)
Percentage of participants with clinical remission at Week 10 in complete modified Mayo score.
Percentage of participants with clinical remission at Week 10 (complete modified Mayo score: stool frequency ≤1, rectal bleeding =0, and site-read endoscopy subscore ≤1).
Measured: From enrollment to the end of treatment at 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start3 Aug 2026 (estimated)
- Primary completion9 Jan 2027 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- AlphaMol Science Ltd. (Shanghai)
- Responsible party
- Principal investigator, Guifang Xu, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744646
- Sponsor's protocol ID
- Alpha-0261-UC-001
- Other IDs
- Alpha-0261-UC-001
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Alpha-0261 Tablets in Patients With Moderate to Severe Active Ulcerative Colitis (UC)
- ClinicalTrials.gov ID
- NCT07744646
- Acronym / sponsor ID
- Alpha-0261-UC-001
- Conditions
- Ulcerative Colitis (UC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Anhui Medical UniversityUniversity, hospital or other
- Collaborators
- AlphaMol Science Ltd. (Shanghai)
- Study start
- 3 Aug 2026 (estimated)
- Primary completion
- 9 Jan 2027 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this protocol is to evaluate the safety and efficacy of Alpha-0261 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that Alpha-0261 is safe, and the secondary hypothesis is that Alpha-0261 is effective, as assessed by the proportion of participants achieving clinical remission per the complete modified Mayo score at Week 10.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpha-0261 | Experimental | Drug: Alpha-0261Participants will take Alpha-0261 tablets orally once daily for 10 consecutive weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 75 years (inclusive), male or female.
- Diagnosed with ulcerative colitis at least 3 months prior to screening; this diagnosis must be confirmed by endoscopy or histology.
- Patients must have moderate-to-severe active ulcerative colitis, as defined by an mMS score of 4 to 9 (blood in stool subscore ≥ 1, frequency of bowel ovements subscore ≥ 1, and colonoscopy subscore ≥ 2 [as confirmed by the study site's image reviewer]; the sum of these three subscores must be at least 4).
- The investigator determines that the participant has had an inadequate response to or is intolerant of at least one conventional therapy aminosalicylates, corticosteroids, or immunosuppressants) or a biologic agent (anti-TNF-α, anti-α4β7 integrin, or anti-IL-12/23 antibodies, etc.).
- Voluntarily sign the informed consent form and be willing to comply with the study procedures and complete the trial in accordance with the protocol.
Key exclusion criteria (10 listed)
- Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment
- Has a current diagnosis of fulminant colitis and/or toxic megacolon
- Has UC limited to the rectum
- Has a history of or is anticipated to require surgical intervention for ulcerative colitis during the study, including but not limited to ostomy, ileal pouch-anal anastomosis, and intestinal resection.
- Has any active infection as specified in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha-0261Drug: Alpha-0261 Oral, tablet | Drug | Alpha-0261 |
Primary outcome
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v6.0
Time frame: From enrollment to the end of study at 12 weeks.
Safety endpoints: These include, but are not limited to, adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examinations, 12-lead electrocardiograms (ECGs), and clinical laboratory tests (complete blood count, urinalysis, blood chemistry, and coagulation tests).
1 secondary outcome
Percentage of participants with clinical remission at Week 10 in complete modified Mayo score.
Time frame: From enrollment to the end of treatment at 10 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alpha-0261 in people with Ulcerative Colitis (UC), run by The First Affiliated Hospital of Anhui Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guifang Xu, Doctor of Medicine (13852293376, xuguifang@fy.ahmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v6.0 (time frame: From enrollment to the end of study at 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.