Phase I Study of QLS1510 Tablets in Healthy Participants

NCT07760077 | Not Yet Recruiting Phase 1

• 1 other identifier: QLS1510-101
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Inflammatory Bowel Disease (IBD)

Outcome Measures

Primary Outcomes (1)

• Number of Participants with treatment-emergent adverse events (TEAEs)

  Up to Week 4

Study Arms (4)

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

Interventions

QLS1510 placebo Tablets DRUG

Oral (swallow)

Multiple ascending doses of placebo; Single ascending doses of placebo

QLS1510 Tablets DRUG

Oral (swallow)

Multiple ascending doses of QLS1510 tablet; Single ascending doses of QLS1510 tablet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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,

Sponsors & Collaborators

• Shanghai Qilu Pharmaceutical Research and Development Center LTD: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Peiying Li, PhD

CONTACT

15800616866; peiyingli.md@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08