Health TrialsbyHealthPanel

A Single Ascending Dose of HRS-4029 in Healthy Subjects

ConditionAcute Ischemic Stroke
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

About this trial

The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of HRS-4029 following a single intravenous dose administration in healthy subjects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 18 to 55 years.

Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive).

Agreed to take effective contraceptive measures during and 3 months after the last dose of the study period.

Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).

Disqualifiers

Diseases with abnormal clinical manifestations that occurred before screening or are currently occurring and need to be excluded.

Vital signs, physical examination, 12-lead electrocardiogram,or laboratory examination deemed clinically significant by the investigator .

Subjects with positive tests for infectious diseases.

Female who are pregnant or breastfeeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-4029

    Drug

    HRS-4029

  • Placebo

    Drug

    Placebo

Treatment groups

55 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Group AExperimental treatment 2 interventions
Group B: Group BExperimental treatment 2 interventions
Group C: Group CExperimental treatment 2 interventions
Group D: Group DExperimental treatment 2 interventions
Group E: Group EExperimental treatment 2 interventions
Group F: Group FExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The incidence and severity of adverse events

Time frame
From ICF signing date to Day15

Secondary outcomes

1

Maximum observed concentration of HRS-4029 (Cmax)

Time frame
0 hour to 48 hour after administration
2

Area under the serum concentration time curve (AUC) of HRS-4029

Time frame
0 hour to 48 hour after administration
3

Time to maximum observed concentration (Tmax) of HRS-4029

Time frame
0 hour to 48 hour after administration
4

Half-life (T1/2) of HRS-4029

Time frame
0 hour to 48 hour after administration

Other outcomes

Sponsors and contacts

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

Beijing Suncadia Pharmaceuticals Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: