Colitis, UlcerativePhase 1NCT07768254
A Study to Evaluate the Safety, Tolerability, PK and Preliminary Efficacy of HX15001 Combined With Etrasimod in Moderate-severe Ulcerative Colitis
A Phase 1 study testing Biological: HX15001 in people with Colitis, Ulcerative, run by Helixon Biotechnology (Suzhou) Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HX15001 injection combined with Etrasimod tablets in participants with moderately to severely active ulcerative colitis (UC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Biological: HX15001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2026to 15 Apr 2028
- 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
- Patient able to read and understand, and willing to sign the informed consent form;
- Weight≥40kg;
- Clinical diagnosis of Ulcerative colitis (UC) that has been present for at least 3 years before the screening visit;
- Mayo score of 5-9 at the baseline visits, including Mayo Endoscopic Score ≥2 and Rectal Bleeding Subscore ≥1, and disease extent from the anal verge ≥ 15 cm at screening.
- Participants with a history of extensive colitis of ≥8 years' duration, or left-sided colitis of ≥10 years' duration, must have had a complete coloscopy within the past 1 year to exclude the presence fo dysplastic lesions.
- Participants who have had an inadequate response to prior treatment with biologic agents or JAK inhibitors.
- Willing and able to comply with clinic visits and study-related procedures.
- Willing to use adequate birth control, if of reproductive potential and sexually active
Who cannot join
- Evidence or history (within 6 months) of fulminant colitis, toxic megacolon, or intestinal perforation.
- Prior colectomy (partial or total), or anticipated need for surgical intervention for UC during the study.
- Prior or current diagnosis of Crohn's disease, fistulas/abscesses, indeterminate colitis, unclassified IBD, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, active diverticulitis, or other colitis/enteritis that may confound efficacy assessment.
- Current unresolved colonic dysplasia, adenoma, adenomatous polyps, or neoplastic lesions. Patients with history of adenomatous polyps are eligible if polyps were completely removed (documented) and screening colonoscopy/histology shows no residual polyps or dysplasia.
- Concomitant primary sclerosing cholangitis or autoimmune hepatitis.
- Malignancy within 5 years prior to screening, except fully resected non-metastatic basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ, or papillary thyroid carcinoma with no recurrence.
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- Major surgery within 6 weeks prior to screening, or planned surgery during the study, unless judged not to increase patient risk or affect study compliance.
- Any condition precluding endoscopic evaluation.
- Unstable or poorly controlled cardiovascular (including atrial fibrillation requiring Class IA/III antiarrhythmics or QT-prolonging agents; unstable ischemic heart disease; Class I/II heart failure; cardiac arrest; cerebrovascular disease; uncontrolled hypertension; symptomatic bradycardia; recurrent cardiogenic syncope; untreated severe sleep apnea; history of second-degree AV block without a functional pacemaker), respiratory, gastrointestinal (excluding UC), hepatic, renal, endocrine, hematologic, neurologic, or psychiatric disease that may compromise patient safety or confound efficacy assessment. - Patients requiring systemic corticosteroids for non-UC conditions (e.g., asthma, adrenal insufficiency, post-transplant) or with peripheral venous access issues are excluded.
- Diabetes mellitus, uveitis, history of ocular surgery/laser, history of maculopathy, or active/uncontrolled macular edema at screening.
- Clinically significant 12-lead ECG abnormalities that may affect safety or interpretation, including QTcF >450 msec (males) or >470 msec (females), QRS >120 msec, or resting heart rate <50 bpm (average of 3 measurements used for qualification).
- Any of the following laboratory abnormalities:
- Hemoglobin <8.0 g/dL
- WBC <2,500/mm³
- Neutrophils <1,000/mm³
- Platelets <100,000/mm³
- Absolute lymphocyte count <500/mm³
- Serum creatinine >2× ULN
- ALT or AST >2× ULN
- Total bilirubin >1.5× ULN
- Any other laboratory abnormality considered by the investigator to pose unacceptable risk.
- History of alcohol, drug, or chemical abuse within 1 year prior to screening.
- Receipt of live or live-attenuated vaccine within 3 months prior to Day 1, or planned during the study or within 5 weeks post-treatment. VZV antibody testing required for patients without documented history or complete vaccination; antibody-positive patients are eligible; antibody-negative patients may rescreen after complete VZV vaccination (≥4 weeks before etrasimod initiation).
- Severe bacterial infection within 3 months (unless resolved with antibiotics), or chronic bacterial infection (e.g., pyelonephritis, osteomyelitis, bronchiectasis).
- C. difficile infection within 30 days prior to Day 1 (may be retested once after 2 weeks of antibiotic therapy; persistent infection excludes enrollment).
- Active invasive fungal infection (e.g., histoplasmosis) or parasitic infection.
- Diagnosis of CMV colitis within 60 days (including screening period). CMV testing on colonic biopsy is required during screening only if clinically suspected.
- Herpes zoster reactivation or CMV infection resolved within 2 months prior to screening.
- Positive for HBsAg, or HBcAb positive with detectable HBV DNA; positive HCV antibody with detectable HCV RNA; positive Treponema pallidum antibody; or positive HIV antibody at screening.
- Positive QuantiFERON-TB Gold or T-SPOT.TB test at screening.
- Use of JAK inhibitors (e.g., tofacitinib, upadacitinib, filgotinib) within 4 weeks (or 5 half-lives, whichever is longer), or anti-TNF agents (e.g., adalimumab, infliximab), vedolizumab, or anti-IL-12/23 agents (e.g., ustekinumab) within 8 weeks (or 5 half-lives, whichever is longer) prior to Day 1.
- Prior S1P receptor modulator therapy without a 3-month washout.
- Use of investigational chemical drugs within 30 days, or investigational biologics within 8 weeks (or 5 half-lives, whichever is longer) prior to Day 1.
- IV corticosteroids within 2 weeks prior to Day 1 or planned during the study.
- Corticosteroid enemas within 4 weeks, or corticosteroid suppositories and/or topical rectal 5-ASA within 2 weeks prior to Day 1, or planned during the study.
- Topical (rectal) herbal enemas or suppositories within 1 week prior to Day 1 or planned during the study.
- Immunosuppressants (e.g., tacrolimus, methotrexate, cyclosporine, mycophenolate mofetil, leflunomide, thalidomide) within 4 weeks (or 5 half-lives, whichever is longer) prior to Day 1 or planned during the study.
- Immunoadsorption or fecal microbiota transplantation within 2 weeks prior to Day 1 or planned during the study.
- NSAIDs (e.g., aspirin >100 mg/day) within 2 weeks prior to Day 1.
- Immunoglobulin or blood products within 1 month prior to Day 1, or any condition likely to require such therapy during the study.
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, 230022
Huan Zhou, 086-13665527160, zhouhuanbest@vip.163.com
About this study
Official title: Evaluation of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HX15001 Injection Combined With Etrasimod Tablets in the Treatment of Moderate-severe Ulcerative Colitis: an Open-label, Exploratory Clinical Trial
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HX15001 injection combined with Etrasimod tablets in participants with moderately to severely active ulcerative colitis (UC).
- Conditions
- Colitis, Ulcerative
- Being tested
- Biological: HX15001
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: HX15001Drug
Dose 1: HX15001
Biological: HX15001Drug
Dose 2: HX15001
Biological: HX15001Drug
Dose 3: HX15001
| Study group | Role | What they receive |
|---|---|---|
| HX15001 Dose 1 | Experimental | Interventions:
Biological: HX15001 Receives: Drug: Biological: HX15001 |
| HX15001 Dose 2 | Experimental | Interventions:
Biological: HX15001 Receives: Drug: Biological: HX15001 |
| HX15001 Dose 3 | Experimental | Interventions:
Biological: HX15001 Receives: Drug: Biological: HX15001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint in the study is the rate of participants with adverse events , serious adverse events, adverse events leading to study withdrawal, and clinically significant abnormalityes in vital signs, ECG, and laboratory test values.
The rate of participants with adverse events , serious adverse events, adverse events leading to study withdrawal, and clinically significant abnormalityes in vital signs, ECG, and laboratory test values.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start9 Sep 2026 (estimated)
- Primary completion15 Apr 2028 (estimated)
- Study completion15 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helixon Biotechnology (Suzhou) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768254
- Sponsor's protocol ID
- HX15001-SIP-001
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 17 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HX15001 Injection Combined With Etrasimod Tablets in the Treatment of Moderate-severe Ulcerative Colitis: an Open-label, Exploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT07768254
- Acronym / sponsor ID
- HX15001-SIP-001
- Conditions
- Colitis, Ulcerative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Helixon Biotechnology (Suzhou) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2026 (estimated)
- Primary completion
- 15 Apr 2028 (estimated)
- Study completion
- 15 Apr 2028 (estimated)
- First posted
- 17 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 study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HX15001 injection combined with Etrasimod tablets in participants with moderately to severely active ulcerative colitis (UC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HX15001 Dose 1 | Experimental | Drug: Biological: HX15001Interventions: Biological: HX15001 |
| HX15001 Dose 2 | Experimental | Drug: Biological: HX15001Interventions: Biological: HX15001 |
| HX15001 Dose 3 | Experimental | Drug: Biological: HX15001Interventions: Biological: HX15001 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient able to read and understand, and willing to sign the informed consent form;
- Weight≥40kg;
- Clinical diagnosis of Ulcerative colitis (UC) that has been present for at least 3 years before the screening visit;
- Mayo score of 5-9 at the baseline visits, including Mayo Endoscopic Score ≥2 and Rectal Bleeding Subscore ≥1, and disease extent from the anal verge ≥ 15 cm at screening.
- Participants with a history of extensive colitis of ≥8 years' duration, or left-sided colitis of ≥10 years' duration, must have had a complete coloscopy within the past 1 year to exclude the presence fo dysplastic lesions.
Key exclusion criteria (40 listed)
- Evidence or history (within 6 months) of fulminant colitis, toxic megacolon, or intestinal perforation.
- Prior colectomy (partial or total), or anticipated need for surgical intervention for UC during the study.
- Prior or current diagnosis of Crohn's disease, fistulas/abscesses, indeterminate colitis, unclassified IBD, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, active diverticulitis, or other colitis/enteritis that may confound efficacy assessment.
- Current unresolved colonic dysplasia, adenoma, adenomatous polyps, or neoplastic lesions. Patients with history of adenomatous polyps are eligible if polyps were completely removed (documented) and screening colonoscopy/histology shows no residual polyps or dysplasia.
- Concomitant primary sclerosing cholangitis or autoimmune hepatitis.
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 |
|---|---|---|
| Biological: HX15001Dose 1: HX15001 | Drug | HX15001 Dose 1 |
| Biological: HX15001Dose 2: HX15001 | Drug | HX15001 Dose 2 |
| Biological: HX15001Dose 3: HX15001 | Drug | HX15001 Dose 3 |
Primary outcome
The primary endpoint in the study is the rate of participants with adverse events , serious adverse events, adverse events leading to study withdrawal, and clinically significant abnormalityes in vital signs, ECG, and laboratory test values.
Time frame: 24 weeks
The rate of participants with adverse events , serious adverse events, adverse events leading to study withdrawal, and clinically significant abnormalityes in vital signs, ECG, and laboratory test values.
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 17 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 Biological: HX15001 in people with Colitis, Ulcerative, run by Helixon Biotechnology (Suzhou) Co., Ltd 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 8 inclusion and 40 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 17 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 Huan Zhou (086-13665527160, zhouhuanbest@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint in the study is the rate of participants with adverse events , serious adverse events, adverse events leading to study withdrawal, and clinically significant abnormalityes in vital signs, ECG, and laboratory test values. (time frame: 24 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 17 Aug 2026.