Inflammatory Bowel Disease (IBD)Phase 1NCT07760077
Phase I Study of QLS1510 Tablets in Healthy Participants
A Phase 1 study testing QLS1510 Tablets in people with Inflammatory Bowel Disease (IBD), run by Shanghai Qilu Pharmaceutical Research and Development Center LTD.
Trial summary
This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QLS1510 in Healthy participants Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease (IBD)
- What is being tested?
- QLS1510 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 30 Apr 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female adults aged between 18 and 45 years, inclusive, at the time of informed consent,
- Medically healthy with no clinically significant or relevant abnormalities in medical history, physical exam, vital signs, ECG, or laboratory evaluations as assessed by the Investigator,
- Body weight ≥50 kg for males and ≥45 kg for females with a body mass index (BMI) between 18.0 and 26.0 kg/m2,
- Participants (including their partners) confirm they have no plans to donate sperm or egg, undergo in vitro fertilization (IVF), or become pregnant, and they agree to use highly effective contraceptive methods.
- Understand and comply with the study procedures and methods, voluntarily participate in the trial, and provide written informed consent.
Who cannot join
- Participants with any disease identified at screening that warrants exclusion in the Investigator's judgment,
- Participants with a history of severe allergic reactions (e.g., angioedema or anaphylactic shock), atopic diathesis (e.g., pollen allergy, allergy to two or more drugs or foods), and/or known hypersensitivity to the IP or any of its components,
- Participants with functional asplenia, history of splenectomy, or prior exposure to immunosuppressive therapies or agents, or any other condition that, in the investigator's judgment, compromises immune function,
- Participants with positive test results for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) and detectable hepatitis B virus deoxyribonucleic acid (HBV-DNA), or positive hepatitis C virus antibody (HCVAb), Treponema pallidum-specific antibody, or human immunodeficiency virus (HIV) antibody during the screening period,
- Participants with a 12-lead ECG at screening/baseline showing QTcF (QT corrected per Fridericia's formula) > 450 msec for males and > 470 msec for females,
- Participants with supine systolic blood pressure ≥140 mmHg or <90 mmHg or diastolic blood pressure ≥90 mmHg or <60 mmHg after resting in the supine position for at least 5 minutes at screening/baseline,
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- Participants with pulse or heart rate (HR) > 100 or < 50 bpm after at least 5 minutes of rest at screening/baseline,
- Participants with any of the following laboratory abnormalities at screening/baseline:
- ALT or AST > upper limit of normal (ULN);
- Total bilirubin > 1.5 ULN (direct bilirubin can be measured in participants with a history of Gilbert's syndrome, and participants can be enrolled into this study if direct bilirubin ≤ ULN),
- Participants with an estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m² at screening/baseline, calculated using the Modification of Diet in Renal Disease (MDRD) formula,
- Participants with a serious infection (e.g., requiring hospitalization, systemic antibacterial therapy, or opportunistic infections) within 6 months prior to screening, or with a history of chronic or recurrent infectious disease that, in the opinion of the investigator, may preclude safe study participation,
- Participants who have received a live (attenuated) vaccine within 6 weeks prior to the first dose of IP, or who plan to receive a live (attenuated) vaccine during the study period or within 8 weeks after the last dose of IP,
- Participants who have participated in clinical trials of another investigational product,
- Participants who have experienced major trauma,
- Participants with an acute illness (e.g., nausea, vomiting, fever, or diarrhea) within 1 week prior to the first dose of IP,
- Pregnant or breastfeeding women or participants with a positive pregnancy test result,
- Participants who, in the investigator's judgment, may be at increased risk of study-related complications, may interfere with the interpretation of study results, or are otherwise unsuitable for study participation.
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 Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Ascending Doses of QLS1510 Tablets in Healthy Adult Participants
This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QLS1510 in Healthy participants
- Conditions
- Inflammatory Bowel Disease (IBD)
- Being tested
- QLS1510 Tablets, QLS1510 placebo Tablets
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS1510 TabletsDrug
Oral (swallow)
QLS1510 placebo TabletsDrug
Oral (swallow)
| Study group | Role | What they receive |
|---|---|---|
| Single ascending doses of QLS1510 tablet | Experimental | Not described Receives: Drug: QLS1510 Tablets |
| Multiple ascending doses of QLS1510 tablet | Experimental | Not described Receives: Drug: QLS1510 Tablets |
| Single ascending doses of placebo | Placebo comparator | Not described Receives: Drug: QLS1510 placebo Tablets |
| Multiple ascending doses of placebo | Placebo comparator | Not described Receives: Drug: QLS1510 placebo Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with treatment-emergent adverse events (TEAEs)
Measured: Up to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (IBD)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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760077
- Sponsor's protocol ID
- QLS1510-101
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Ascending Doses of QLS1510 Tablets in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07760077
- Acronym / sponsor ID
- QLS1510-101
- Conditions
- Inflammatory Bowel Disease (IBD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTDIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 12 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.
This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QLS1510 in Healthy participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single ascending doses of QLS1510 tablet | Experimental | Drug: QLS1510 Tablets |
| Multiple ascending doses of QLS1510 tablet | Experimental | Drug: QLS1510 Tablets |
| Single ascending doses of placebo | Placebo comparator | Drug: QLS1510 placebo Tablets |
| Multiple ascending doses of placebo | Placebo comparator | Drug: QLS1510 placebo Tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female adults aged between 18 and 45 years, inclusive, at the time of informed consent,
- Medically healthy with no clinically significant or relevant abnormalities in medical history, physical exam, vital signs, ECG, or laboratory evaluations as assessed by the Investigator,
- Body weight ≥50 kg for males and ≥45 kg for females with a body mass index (BMI) between 18.0 and 26.0 kg/m2,
- Participants (including their partners) confirm they have no plans to donate sperm or egg, undergo in vitro fertilization (IVF), or become pregnant, and they agree to use highly effective contraceptive methods.
- Understand and comply with the study procedures and methods, voluntarily participate in the trial, and provide written informed consent.
Key exclusion criteria (18 listed)
- Participants with any disease identified at screening that warrants exclusion in the Investigator's judgment,
- Participants with a history of severe allergic reactions (e.g., angioedema or anaphylactic shock), atopic diathesis (e.g., pollen allergy, allergy to two or more drugs or foods), and/or known hypersensitivity to the IP or any of its components,
- Participants with functional asplenia, history of splenectomy, or prior exposure to immunosuppressive therapies or agents, or any other condition that, in the investigator's judgment, compromises immune function,
- Participants with positive test results for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) and detectable hepatitis B virus deoxyribonucleic acid (HBV-DNA), or positive hepatitis C virus antibody (HCVAb), Treponema pallidum-specific antibody, or human immunodeficiency virus (HIV) antibody during the screening period,
- Participants with a 12-lead ECG at screening/baseline showing QTcF (QT corrected per Fridericia's formula) > 450 msec for males and > 470 msec for females,
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 |
|---|---|---|
| QLS1510 TabletsOral (swallow) | Drug | Multiple ascending doses of QLS1510 tablet, Single ascending doses of QLS1510 tablet |
| QLS1510 placebo TabletsOral (swallow) | Drug | Multiple ascending doses of placebo, Single ascending doses of placebo |
Primary outcome
Number of Participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to Week 4
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 12 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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 QLS1510 Tablets in people with Inflammatory Bowel Disease (IBD), run by Shanghai Qilu Pharmaceutical Research and Development Center LTD.
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 18 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 12 Aug 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 Peiying Li, PhD (15800616866, peiyingli.md@gmail.com), 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-emergent adverse events (TEAEs) (time frame: Up to Week 4). 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 12 Aug 2026.