NCT04783090

MT1013 Clinical TRIAL In Healthy Subject

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	MT1013	bispecific peptide as a CaSR agonist and a functional OGP analogue

Timeline

• Start date: 2021-06-28
• Primary completion: 2021-12-31
• Completion: 2022-03-17
• First posted: 2021-03-05
• Last updated: 2022-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study