NCT06561542

A Phase I Study of LX22001 for Injection in Healthy Subjects

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Shandong Luoxin Pharmaceutical Group Stock Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-08-05
• Primary completion: 2025-11-21
• Completion: 2025-11-21
• First posted: 2024-08-20
• Last updated: 2024-08-20

Locations

1 site across 1 country: China