A Phase I Trial of QLS1410 in Healthy Chinese Adults and Participants With Mild Essential Hypertension

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • QLS1410 (CYP11B2 inhibitor)
  • placebo

Treatment groups

78 Participants
are divided into 2 treatment groups

Sponsors and collaborators