Single Ascending Dose Trial to Evaluate the Safety, Tolerability, PK, and PD of MT1002 for Injection
NCT04116840 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2022-07-29
Summary
This is an open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single dose of MT1002 for injection following intravenous bolus/infusion ascending dose administration.
Conditions
- Healthy
Interventions
- DRUG
-
MT1002 for injection
Study drug will be administered by an intravenous bolus dose followed by an infusion of 4 hours.
Sponsors & Collaborators
-
Shaanxi Micot Pharmaceutical Technology Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Mohamed Al-Ibrahim, MB · Pharmaron CPC, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-04-29
- Primary Completion
- 2019-08-01
- Completion
- 2019-11-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
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