Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HRS-6257

    Drug

    HRS-6257

  • placebo

    Drug

    placebo

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: HRS-6257 groupExperimental treatment 1 intervention
Group B: placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The incidence and severity of adverse events

Time frame
from ICF signing date to Day 14 or Day 21 or Day 27

Secondary outcomes

1

AUC of HRS-6257

Time frame
0 hour to 72 hour after administration
2

Cmax of HRS-6257

Time frame
0 hour to 72 hour after administration
3

Tmax of HRS-6257

Time frame
0 hour to 72 hour after administration
4

t1/2 of HRS-6257

Time frame
0 hour to 72 hour after administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Hengrui Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now