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NCT07358858Not yet recruitingPhase 1

A Food Effect Study of QLS1410 in Healthy Chinese Adults

A Randomized, Open-label, Two-period, Crossover Food Effect Study of QLS1410 in Healthy Chinese Adults

Source: ClinicalTrials.gov · Last updated 22 Jan 2026

Brief summary (registry, in English)

This study is aimed to evaluate the effect of food on pharmacokinetics of QLS1410 in healthy Chinese adults.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
12 (estimated)
First submitted
7 Jan 2026
Start date
23 Jan 2026
Primary completion date
7 Feb 2026
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
NCT number
NCT07358858

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 12
  • From 23 Jan 2026 to the primary completion date, 7 Feb 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of systemic corticosteroids within 3 months prior to screening.
  • Smoking \>5 cigarettes/day on average within 6 months before screening, or current use of e-cigarettes.
  • Alcohol consumption \>14 units/week (1 unit = 357 mL of 3.5% beer, 27 mL of 40% spirits, or 104 mL of 12% wine) within 6 months before screening, or has a positive breath alcohol test at screening.
  • Blood donation \>400 mL within 3 months or \>200 mL within 4 weeks before screening, or plan to donate blood during the study.
  • Use of strong CYP3A4 or CYP1A2 inhibitors within 7 days or 5 half-lives (whichever is longer) before screening. Use of strong CYP3A4 inducer within 14 days or 5 half-lives (whichever is longer) before screening.
  • Use of any prescription drugs, OTC drugs, traditional medicines, and dietary supplements within 2 weeks or 5 half-lives (whichever is longer) prior to randomization.

Other illness

  • Any medical condition/disease at screening deemed by the investigator to require exclusion, including but not limited to the cardiovascular, respiratory, digestive, urinary, endocrine metabolic, skeletal, muscular, hematologic, immune, nervous system.
  • Dysphagia or any surgical condition/disease that may affect drug absorption, distribution, metabolism, or excretion, at screening.
  • Active viral hepatitis (B or C), TP, and HIV as demonstrated by positive serology at Screening.

Lab values

  • Any clinically significant abnormal result of vital signs, physical examinations, laboratory tests, chest X-ray, and abdominal B-ultrasound, at screening.
  • Any of the following laboratory abnormalities at screening: ALT or AST \>1.5 x upper limit of normal (ULN); Total bilirubin \>1.5 x ULN (participants with Gilbert's syndrome may qualify if direct bilirubin ≤ULN); Creatinine \>ULN or eGFR \<90 mL/min/1.73 m²; Serum potassium \>ULN or sodium \<135 mmol/L.

Other

  • Mean pulse \>100 or \<50 bpm after ≥5 min of rest at screening (measured 3 times consecutively).
  • Pregnant/lactating females or positive pregnancy test at screening.
  • Inability to tolerate a high-fat meal.

Who the study is looking for

  • Able to understand and willing to comply with all study visits, procedures, restrictions and provide the written informed consent form (ICF).
  • Males and females aged 18 to 55 years, inclusive.
  • Weight ≥ 50 kg for males and ≥ 45 kg for females, Body mass index (BMI) between 18 and 26 kg/m\^2, inclusive, at screening.
  • Has a mean seated office systolic blood pressure (SBP) 110\~139 mmHg (inclusive) and diastolic blood pressure (DBP) 70\~89 mmHg (inclusive) at screening and baseline; measured 3 times consecutively (1-2 min intervals).
  • QTcF (QT corrected using Fridericia's formula) \<450 ms for males and \<470 ms for females.
  • Participants (including partners) must agree to abstain from sperm/egg donation and pregnancy plans, and to use highly effective contraception, from signing the ICF until 3 months after receiving the last dose of investigational product.

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.