A Food Effect Study of QLS1410 in Healthy Chinese Adults

NCT07358858 | Not Yet Recruiting Phase 1

• 1 other identifier: QSL1410-102
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Uncontrolled Hypertension

Outcome Measures

Primary Outcomes (3)

• AUC0-∞

  0 to 96 hours

• Area under the curve plasma concentration from time zero to Time of Last Quantifiable Concentration

  0 to 96 hours

• Maximum observed plasma concentration

  0 to 96 hours

Study Arms (1)

QLS1410 20mg

EXPERIMENTAL

Drug: QLS1410

Interventions

QLS1410 DRUG

QLS1410 tablets

QLS1410 20mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Dysphagia or any surgical condition/disease that may affect drug absorption, distribution, metabolism, or excretion, at screening.
• Use of systemic corticosteroids within 3 months prior to screening.
• Any clinically significant abnormal result of vital signs, physical examinations, laboratory tests, chest X-ray, and abdominal B-ultrasound, at screening.
• Active viral hepatitis (B or C), TP, and HIV as demonstrated by positive serology at Screening.
• Mean pulse \>100 or \<50 bpm after ≥5 min of rest at screening (measured 3 times consecutively).
• 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.
• 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.
• Pregnant/lactating females or positive pregnancy test at screening.
• Inability to tolerate a high-fat meal.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Central Study Contacts

Yuguo Chen, B.M.

CONTACT

（+86）0531-82169023; chen919085@126.com

Wei Zhao, M.D.

CONTACT

（+86）0531-82169023; zhao4wei2@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 22, 2026
• Study Start: January 23, 2026
• Primary Completion: February 7, 2026
• Study Completion: February 7, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01