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Evaluate the Effects of Renal Impairment on the Pharmacokinetics and Pharmacodynamics

NCT05323136 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-01-26

No results posted yet for this study

Summary

The study is a multicenter, Phase 1, open-label, sequential, adaptive, single dose, PK/PD study in subjects with moderate and severe RI and healthy volunteers (HV).

Conditions

  • ACS - Acute Coronary Syndrome

Interventions

DRUG

MT1002 for Injection

single dose: 0.90 mg/kg initial loading dose (bolus intravenous injection) over 5 minutes + 1.8 mg/kg/hour (infusion) for 4 hours.

Sponsors & Collaborators

  • Shaanxi Micot Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-04-15
Primary Completion
2022-06-29
Completion
2022-06-29
FDA Drug
Yes

Countries

  • United States

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 NCT05323136 on ClinicalTrials.gov