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A Phase I Study of LX22001 for Injection in Healthy Subjects

NCT06561542 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-08-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hongyun Wang · Peking Union Medical College

  • Hongzhong Liu · Peking Union Medical College

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-05
Primary Completion
2025-11-21
Completion
2025-11-21

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06561542 on ClinicalTrials.gov