Health TrialsbyHealthPanel

A Single Ascending Dose of HRS-2162 in Healthy Subjects

ConditionReversal of Neuromuscular Blockade
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

The study is being conducted to evaluate the safety and tolerability of HRS-2162 injection in a single dose in healthy subjects, as well as the characteristics of PK/PD

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The subjects voluntarily signed the informed consent form.

Applicants must be between 18 and 45 years old at the time of signing the informed consent form, and both men and women are eligible .

ASA classification is Grade I (only Parts Two and three)

Male weight ≥50 kg, female weight ≥45 kg, body mass index between 19 and 28 kg/m ².

Disqualifiers

Those with a past or current clinical acute or chronic disease

Those with a history of hereditary bleeding or coagulation disorders or non-traumatic bleeding .

Those with a history of neuromuscular diseases or poliomyelitis

Those with a history of anesthesia complications.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-2162

    Drug

    HRS-2162

  • Placebo

    Drug

    Placebo

Treatment groups

64 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Dose Level：A1(Part1)Experimental treatment 2 interventions
Group B: Dose Level：A2(Part1) .Experimental treatment 2 interventions
Group C: Dose Level：B(Part1+Part2)Experimental treatment 2 interventions
Group D: Dose Level：C(Part1)Experimental treatment 2 interventions
Group E: Dose Level：D(Part1+Part3)Experimental treatment 2 interventions
Group F: Dose Level：E(Part1)Experimental treatment 2 interventions
Group G: Dose Level：F(Part3)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence and severity of adverse events

Time frame
From ICF signing date to Day7

Secondary outcomes

1

Maximum observed concentration of HRS-2162 (Cmax)

Time frame
0 hour to 24 hour after administration
2

Area under the serum concentration time curve (AUC) of HRS-2162

Time frame
0 hour to 24 hour after administration
3

Time to maximum observed concentration (Tmax) of HRS-2162

Time frame
0 hour to 24 hour after administration
4

Half-life (T1/2) of HRS-2162

Time frame
0 hour to 24 hour after administration

Other outcomes

Sponsors and contacts

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

Fujian Shengdi Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now