NCT04116840

Single Ascending Dose Trial to Evaluate the Safety, Tolerability, PK, and PD of MT1002 for Injection

An Open-label, Sequential Parallel Group, Single Ascending Dose Following Intravenous Bolus/Infusion Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MT1002 for Injection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

An initial, single dose escalation study of MT1002 for injection for injection in heathy subjects will be performed to evaluate safety, pharmacokinetics, and pharmacodynamics after intravenous bolus and infusion administration. A total of 36 subjects (6 subjects per cohort) in 6 dose levels . At each dose level, a single sentinel subject will be dosed first. Sentinel subjects will receive a phone call at 48 hours ±4 hours to inquire about their status. If no dose-limiting toxicity is observed for 48 hours post-dose, the remaining 5 subjects in that dose level will be treated.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	MT1002 for injection	Study drug will be administered by an intravenous bolus dose followed by an infusion of 4 hours.

Timeline

• Start date: 2019-04-29
• Primary completion: 2019-08-01
• Completion: 2019-11-27
• First posted: 2019-10-07
• Last updated: 2022-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study