A Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects
ConditionPain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.
About this trial
This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of HRS-6257 in healthy volunteers.
Eligibility criteria
Qualifiers
Aged between 18 and 55 years old (based on the time of signing the informed consent form), both males and females are eligible.
The body weight of males ≥ 50 kg, and that of females ≥ 45 kg, and body mass index (BMI): 19 - 28 kg/m².
Female subjects must be non-pregnant or non-childbearing potential;
Subjects must understand the study procedures and methods, voluntarily participate in this study and sign the ICF in person.
Disqualifiers
History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological disease;
Known or suspected hypersensitivity to trial product(s) or related products;
12-lead ECG demonstrating QTcF >450 msec or history or risk factors for QT prolongation;
Blood donation of more than 200 mL within the last 6 months
Trial design
Treatments tested in this trial
- HRS-6257
- placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov