MT1013 Clinical TRIAL In Healthy Subject

Healthy Volunteer Clinical Trial

Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Administration Phase 1 Clinical Trial to Evalute the Satety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamics of MT1013 Injection in Healthy Subjects

Status Completed

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, single ascending dose administration phase one clinical trial to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of MT1013 injection in healthy subjects.

Clinical Trial Description

This will be a single center, Phase 1, randomized, double-blind single-dose, sequential SAD study.

This SAD study will consist of up to 5 cohorts (1 cohort per dose level). Each cohort will include 8 subjects (6 subjects receiving the active study drug and 2 subjects receiving matching placebo).

A staggered dosing schedule will be used for each dose level administered under fasting conditions. Two (2) sentinel subjects (1 active and 1 placebo) will be dosed first (a minimum of 1 hour apart) and the remaining 6 subjects will be dosed no sooner than the next day (each dosed at least 15 minutes apart).

Following completion of each dose level, a SRC will review the safety and tolerability data as well as the available PK data up to 48 hours in order to make decisions whether to escalate to the next dose level, decrease the next dose level, repeat a dose level, or to not evaluate any additional dose. ;

Related Conditions & MeSH terms

• Healthy Volunteer

• NCT number: NCT04783090
• Study type: Interventional
• Source: Shaanxi Micot Technology Limited Company
• Status: Completed
• Phase: Phase 1
• Start date: June 28, 2021
• Completion date: March 17, 2022