The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of single and multiple ascending doses of QLS1410 in healthy Chinese adults and participants with mild essential hypertension
Part A & Part B: Healthy Participants
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.
Part A & Part B: Healthy Participants
Any medical condition/disease at screening deemed by the investigator to require exclusion, including but not limited to the nervous, psychiatric, cardiovascular, hematologic/lymphatic, immune, respiratory, digestive, urinary, metabolic and skeletal systems.
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.
Parallel
QLS1410 (CYP11B2 inhibitor)
DrugQLS1410 tablets
placebo
DrugMatching placebo tablets
Incidence and severity of treatment emergent Adverse Events as assessed by CTCAE v5.0
Area under the curve plasma concentration from time zero to last measurable concentration [AUC(0-last)]
Area under the curve plasma concentration from time zero to infinity [AUC(0-∞)]
Maximum observed plasma concentration (Cmax)
Terminal elimination half-life (t1/2)
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This trial is not recruiting at the moment. You can still explore other options:
