A Food Effect Study of QLS1410 in Healthy Chinese Adults
ConditionUncontrolled Hypertension
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
This study is aimed to evaluate the effect of food on pharmacokinetics of QLS1410 in healthy Chinese adults.
Eligibility criteria
Qualifiers
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/m², 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).
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- QLS1410
Treatment groups
12 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov