A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Bolus and Infusion HRS-9190 in Healthy Adults

Summary

This study is divided into two parts. The first part adopts a single-center, randomized, single-blind, placebo-controlled dose escalation trial design to investigate the safety, tolerability, pharmacokinetics (PK), and effects on the QTc interval in healthy subjects after a single administration of HRS-9190 for injection at doses of 3 times or 6 times the ED95. The second part uses a single-center, open-label trial design to examine the safety, tolerability, PK, pharmacodynamics (PD), and reversal effect of neostigmine (in combination with atropine) after intravenous bolus injection and continuous intravenous infusion of the loading dose (2 times the ED95) of HRS-9190 under different anesthesia regimens.

Timeline

Start

2025-08-26

Primary completion

2025-10-31

Completion

2025-10-31

Drugs

Indications

No indication recorded.