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QLC1101 Pharmacokinetics in Fasting and Fed Healthy Adults

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What is being tested

QLC1101

Drug
Who is being recruted

From 18 to 45 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorQilu Pharmaceutical Co., Ltd.
Study ContactWei Hu, PHD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2025

Actual date on which the first participant was enrolled.

This clinical trial aims to understand how the new drug, QLC1101, behaves in the body when taken as a single dose in different eating conditions. It focuses on healthy adults and investigates how the body absorbs and processes the drug when they take it without food, after a high-fat meal, and after a low-fat meal. Understanding these differences is crucial, as it can help determine the best way to take the medication for future patients, ensuring its effectiveness and safety. Participants in this study will be divided into three groups and will take QLC1101 capsules in different sequences, once on an empty stomach, once after eating a high-fat meal, and once after a low-fat meal. Each participant will go through three phases with breaks in between to ensure the drug is cleared from their system before the next phase. The study will closely track how the drug is absorbed and processed in each scenario, which helps in understanding the influence of food on the medication's effectiveness. This information will be vital to guide future recommendations on how the drug should be taken.

Official TitleA Single-dose, Randomized, Open-label, Three-period, Crossover Pharmacokinetic Study of QLC1101 in Healthy Subjects in the Fasting and Fed State
NCT06980909
Principal SponsorQilu Pharmaceutical Co., Ltd.
Study ContactWei Hu, PHD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Male subjects weigh ≥50 kg, female subjects weigh ≥45 kg.
BMI is within the range of 18.0~28.0 kg/m2 (including the boundary value).
2 exclusion criteria prevent from participating
Those who have a history of allergies to drugs, food, pollen, or other clear allergies, or those who are allergic to the experimental drugs and their ingredients;
Patients with dysphagia or any disease that affects drug absorption, distribution, metabolism and excretion, especially those with a history of gastrointestinal diseases (such as gastric ulcer, gastric bleeding, long-term diarrhea, etc.)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
fasting, high-fat diet, low-fat diet

Group II

Experimental
high-fat diet, low-fat diet, fasting

Group III

Experimental
low-fat diet , fasting, high-fat diet

Study Objectives

Primary Objectives

Study Centers

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