Ulcerative Colitis (UC)Phase 1TP317-301NCT07834515
Phase 1b Clinical Study in Patients With Active Ulcerative Colitis
A Phase 1 study testing TP317 in people with Ulcerative Colitis (UC), run by Thetis Pharmaceuticals LLC.
Trial summary
Purpose of study is to evaluate the safety, tolerability, pharmacokinetics of TP317 vs. placebo in adults with active ulcerative colitis. Participants will be randomly assigned to receive either daily oral tablets (8 tablets) of TP317 (80 mg) or an identical placebo pill. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- TP317
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 16 Sep 2026to 29 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of UC with disease duration of at least 12 weeks prior to randomization
- Evidence of active UC at Screening, defined by all of the following:
- MMS of 5 to 8, inclusive;
- ES ≥ 2;
- RBS of ≥ 1; and
- Evidence of active UC extending ≥15 cm from the anal verge via colonoscopy (confirmed by central read)
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- UCEIS score ≥ 4 with erosion/ulcer sub-score of ≥1 (confirmed by central read)
- An inadequate response to, loss of response to, or intolerance to at least 1 of the following conventional therapies as defined below:
- Oral 5-ASA compounds
- Glucocorticoids (topical or systemic)
- Thiopurines
- If receiving oral 5-aminosalicylates (5-ASAs) or oral corticosteroids (≤20 mg prednisolone equivalent) for treatment of their UC, they must be on a stable dose for at least 28 days prior to randomization
- Previous exposure to a single biologic agent, JAK inhibitor, or S1P inhibitor is allowed (not required) if it was discontinued for reasons other than primary no response. Discontinuation must have been more than 8 weeks or 5 half-lives (whichever is longer) prior to first dose of study treatment.
Who cannot join
- Severe extensive colitis as evidenced by:
- Likeliness to require hospitalization for medical care or surgical intervention of any kind for UC (e.g., colectomy) within 12 weeks after randomization
- Current evidence of fulminant colitis, toxic megacolon, or recent history (within 6 months prior to screening) of toxic megacolon, or bowel perforation
- Has severe UC during as defined by ≥6 bloody stools per day AND at least 1 of the following during Screening:
- Pulse >90 bpm
- Oral temperature of >37.8 °C
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- Hemoglobin <10.5 g/dL
- CRP of >30 mg/L
- Erythrocyte sedimentation rate >30 mm/h
- Diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, acute diverticulitis, or the presence or history of a fistula consistent with CD based on medical history
- History of or current evidence of colonic dysplasia; or recent history (within 2 years prior to randomization). Note: If adenomatous polyps present, must be completely removed per routine practice prior to the study participant's first dose of investigational product.
- History of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy; or is planning to undergo bowel surgery during the course of the study.
- History of spontaneous gastrointestinal (GI) perforation (other than appendicitis or mechanical injury), or at significantly increased risk of GI perforation based on the Investigator's judgment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy Signal of TP-317 in Patients With Active Ulcerative Colitis
Purpose of study is to evaluate the safety, tolerability, pharmacokinetics of TP317 vs. placebo in adults with active ulcerative colitis. Participants will be randomly assigned to receive either daily oral tablets (8 tablets) of TP317 (80 mg) or an identical placebo pill. Study will include 2 colonoscopies, daily dosing (including at home and in clinic), safety assessments, diary and questionnaire completion and 5 in clinic visits.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- TP317, Matching placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TP317Drug
8 tablets (80 mg) of TP317 oral tablets, taken once daily under fasted conditions for a total duration of 12 weeks.
Matching placeboDrug
Matching oral tablet containing no active ingredients, taken once daily for 12 weeks to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Active TP317 80 mg | Active comparator | Participants will receive 8 tablets (80 mg) of TP317 daily, via oral administration for 12 weeks Receives: Drug: TP317 |
| Placebo | Placebo comparator | Participants will receive 8 tablets of matching Placebo daily, via oral administration for 12 weeks Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of TP317
Incidence, duration and severity of all adverse events (AEs).
Measured: Collected from baseline through Week 12
Safety of TP317
Number of Participants with Clinically Significant Laboratory Abnormalities
Measured: Baseline through Week 12
Safety of TP317
Number of Participants with Clinically Significant ECG Abnormalities
Measured: Baseline through Week 12
Safety of TP317
Changes in 12-lead electrocardiogram parameters
Measured: Baseline to Week 12
Pharmacokinetics of TP317
Maximum observed plasma concentration (Cmax) of TP317
Measured: Baseline through Week 12
Pharmacokinetics of TP317
Time to maximum observed plasma concentration (Tmax) of TP317
Measured: Baseline through Week 12
Pharmacokinetics of TP317
Area under the plasma concentration-time curve
Measured: Baseline through Week 12
Pharmacokinetics of TP317
Plasma elimination half-life (t1/2) of TP317
Measured: Baseline through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start16 Sep 2026 (estimated)
- Primary completion29 Jul 2027 (estimated)
- Study completion29 Aug 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 3:1 ratio to receive either the active intervention or the placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thetis Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834515
- Sponsor's protocol ID
- TP317-301
- Acronym
- TP317-301
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy Signal of TP-317 in Patients With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT07834515
- Acronym / sponsor ID
- TP317-301 / TP317-301
- Conditions
- Ulcerative Colitis (UC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Thetis Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2026 (estimated)
- Primary completion
- 29 Jul 2027 (estimated)
- Study completion
- 29 Aug 2027 (estimated)
- First posted
- 22 Sep 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.
Purpose of study is to evaluate the safety, tolerability, pharmacokinetics of TP317 vs. placebo in adults with active ulcerative colitis. Participants will be randomly assigned to receive either daily oral tablets (8 tablets) of TP317 (80 mg) or an identical placebo pill. Study will include 2 colonoscopies, daily dosing (including at home and in clinic), safety assessments, diary and questionnaire completion and 5 in clinic visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 3:1 ratio to receive either the active intervention or the placebo.
| Arm | Type | Receives |
|---|---|---|
| Active TP317 80 mg | Active comparator | Drug: TP317Participants will receive 8 tablets (80 mg) of TP317 daily, via oral administration for 12 weeks |
| Placebo | Placebo comparator | Drug: Matching placeboParticipants will receive 8 tablets of matching Placebo daily, via oral administration for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of UC with disease duration of at least 12 weeks prior to randomization
- Evidence of active UC at Screening, defined by all of the following:
- UCEIS score ≥ 4 with erosion/ulcer sub-score of ≥1 (confirmed by central read)
- An inadequate response to, loss of response to, or intolerance to at least 1 of the following conventional therapies as defined below:
- If receiving oral 5-aminosalicylates (5-ASAs) or oral corticosteroids (≤20 mg prednisolone equivalent) for treatment of their UC, they must be on a stable dose for at least 28 days prior to randomization
Key exclusion criteria (13 listed)
- Severe extensive colitis as evidenced by:
- Has severe UC during as defined by ≥6 bloody stools per day AND at least 1 of the following during Screening:
- Diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, acute diverticulitis, or the presence or history of a fistula consistent with CD based on medical history
- History of or current evidence of colonic dysplasia; or recent history (within 2 years prior to randomization). Note: If adenomatous polyps present, must be completely removed per routine practice prior to the study participant's first dose of investigational product.
- History of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy; or is planning to undergo bowel surgery during the course of the study.
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 |
|---|---|---|
| TP3178 tablets (80 mg) of TP317 oral tablets, taken once daily under fasted conditions for a total duration of 12 weeks. | Drug | Active TP317 80 mg |
| Matching placeboMatching oral tablet containing no active ingredients, taken once daily for 12 weeks to maintain blinding. | Drug | Placebo |
Primary outcome
Safety of TP317
Time frame: Collected from baseline through Week 12
Incidence, duration and severity of all adverse events (AEs).
Safety of TP317
Time frame: Baseline through Week 12
Number of Participants with Clinically Significant Laboratory Abnormalities
Safety of TP317
Time frame: Baseline through Week 12
Number of Participants with Clinically Significant ECG Abnormalities
Safety of TP317
Time frame: Baseline to Week 12
Changes in 12-lead electrocardiogram parameters
Pharmacokinetics of TP317
Time frame: Baseline through Week 12
Maximum observed plasma concentration (Cmax) of TP317
Pharmacokinetics of TP317
Time frame: Baseline through Week 12
Time to maximum observed plasma concentration (Tmax) of TP317
Pharmacokinetics of TP317
Time frame: Baseline through Week 12
Area under the plasma concentration-time curve
Pharmacokinetics of TP317
Time frame: Baseline through Week 12
Plasma elimination half-life (t1/2) of TP317
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 22 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TP317 in people with Ulcerative Colitis (UC), run by Thetis Pharmaceuticals LLC.
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 13 inclusion and 13 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Head of Clinical Development Operations (203-936-8936, bpaperiello@thetispharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of TP317 (time frame: Collected from baseline through Week 12). The study lists 8 primary outcomes in all. 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 22 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.