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RECRUITING
NCT06561542
PHASE1

A Phase I Study of LX22001 for Injection in Healthy Subjects

Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

View on ClinicalTrials.gov

Summary

Study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics (PK/PD) parameters of an escalating, single dose/repeat doses of LX22001 for injection in healthy subjects.

Official title: A Phase I, Escalating Single and Multiple Dose Study of LX22001 for Injection to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Bioavailability in Healthy Subjects.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2024-08-05

Completion Date

2025-11-21

Last Updated

2024-08-20

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

LX22001 for Injeciton

single dose: 25mg,50mg,100mg,200mg ,intravenous infusion. repeat doses: 50mg,100mg , intravenous infusion,once daily for 3 days.

DRUG

Tegoprazan tablet

50mg,oral,single dose

DRUG

Esomeprazole sodium for injection

80 mg intravenous infusion for 30 min followed by a continuous infusion of 8 mg/h for 71.5h

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China