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A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Effect of Food on the Pharmacokinetics of HRS4800 in Healthy Male Participants

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A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Effect of Food on the Pharmacokinetics of HRS4800 in Healthy Male Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Apr 2022

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At a glance

  • Drugs HRS 4800 (Primary)
  • Indications Pain
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Atridia

    • Most Recent Events

    • 28 Mar 2022 Status changed from recruiting to completed.
    • 28 Mar 2022 The primary endpoints changed from Incidence of AEs, severity of AEs, and Change in diastolic blood pressure and systolic blood pressure from baseline, diastolic blood pressure and systolic blood pressure from baseline, respiratory rate from baseline,QT interval from baseline by ECG, corrected QT (QTc) interval from baseline by ECG, and P-R interval from baseline by ECG to HRS4800 Single Dose Escalation - Safety, AUC0-t, AUC0-infi, Tmax, Cmax, t1/2,CL/F, and Vz/F, according to Clinicaltrials.gov
    • 28 Jul 2021 Planned End Date changed from 1 Oct 2021 to 1 Dec 2021.

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