A Phase 1 interventional study of HRS3797 and HRS3797 in Skeletal Muscle Relaxation, sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-07.
Sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
This is a single-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS3797 in Chinese adults. To evaluate the effect of IV infusion duration on the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS3797. To explore the ED95 dosage of HRS3797 in Chinese adults.
Fujian Shengdi Pharmaceutical Co., Ltd. is the lead sponsor of 65 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HRS3797 for injection
Drug: HRS3797
HRS3797 for injection
Drug: HRS3797
HRS3797 for injection
Drug: HRS3797
HRS3797 for injection
Drug: HRS3797
HRS3797 for injection
Drug: HRS3797
HRS3797 for injection
Drug: HRS3797
HRS3797 for injection, low dose
HRS3797 for injection, medium dose
HRS3797 for injection, high dose
Maximum T1 Suppression
Time frame: 0 minute to full neuromuscular recovery after administration
Time to Maximum T1 Suppression
Time frame: 0 minute to full neuromuscular recovery after administration
The onset of neuromuscular block
Time frame: 0 minute to full neuromuscular recovery after administration
The duration of neuromuscular block
Time frame: 0 minute to full neuromuscular recovery after administration
The recovery rate of neuromuscular block
Time frame: 0 minute to full neuromuscular recovery after administration
Pharmacokinetic parameter of HRS3797: Cmax
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: AUC0-t
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: AUC0-∞
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: Tmax
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: t1/2z
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: CLz
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: Vz
Time frame: 0 minute to 1.5 hour after administration
The change of plasma histamine concentration from baseline
Time frame: 0 minute to 1 hour after administration
The incidence and severity of adverse events/serious adverse events
Time frame: from ICF signing date to day 28
The ED95 dosage
Time frame: 0 minute to full neuromuscular recovery after administration
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Fujian Shengdi Pharmaceutical Co., Ltd.