SAL0140 Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Healthy Chinese Population

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShenzhen Salubris Pharmaceuticals Co., Ltd.

About this trial

The purpose of this study is to evaluate the safety, tolerability pharmacokinetics and pharmacodynamics of SAL0140 healthy Chinese population.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subjects has fully understood and voluntarily signed the informed consent form, and is able to comply with the requirements and restrictions listed in the informed consent form;

Male or female aged 18-65 years (including 18 and 65 years old);

Male body weight ≥50kg, female body weight ≥45kg and body mass index (BMI) between 19.0 - 26.0 kg/m2 (including 19.0 and 26.0, BMI = weight(kg) / height(cm)2) at screening;

All examinations (including physical examination, vital signs, laboratory tests, ECG, chest X-ray (anterior and lateral views), etc.) show no abnormalities or minor abnormalities deemed non clinical signiant by the investigator;

Disqualifiers

Subjects with orthostatic tachycardia or orthostatic hypotension at screening; or those with a history of orthostatic hypotension symptoms (such as dizziness, fatigue, blurred vision, pallor upon standing) or orthostatic tachycardia symptoms (such as dizziness, palpitations, tremors, general weakness, blurred vision, exercise intolerance when standing);

Subjects have used corticosteroids within 3 months prior to dosing;

Subjects with personal or family history of long QT syndrome, torsades de pointes, or other complex arrhythmias, or family history of sudden death;

Subjects with prolonged QTcF interval (>450msec) on ECG;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SAL0140

    Drug

    In this part, SAL0140 tablets will be administered as a single or multiple oral dose.

  • SAL0140 placebo

    Drug

    In this part, SAL0140 placebo tablets will be administered as a single or multiple oral dose.

Treatment groups

82 Participants
are divided into 3 treatment groups
Group A: Single Ascending Doses (SAD, Part A)Experimental treatment 2 interventions
Group B: Experimental: Foode Effect (FE, Part B)Experimental treatment 1 intervention
Group C: Experimental: Single Ascending Doses (MAD, Part C)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The rate of Adverse events

The rate of Adverse events occur during the whole study

Time frame
from Day 1 to Day8 or Day23 or Day28
2

The rate of normality or abnormality of electrocardiogram

The rate of normality or abnormality of electrocardiogram during the whole study

Time frame
from Day 1 to Day8 or Day23 or Day28

Secondary outcomes

Other outcomes

Sponsors and contacts

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