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First-In-Man, Healthy Volunteer Study to Evaluate Safety on the Use of YQ23

Healthy Volunteers Clinical Trial

Official title:
First-In-Man, Phase I, Single-Blind, Placebo-Controlled, Ascending Single Dose Study of Intravenous YQ23 in Healthy Male and Female Subjects to Assess Safety, Tolerability, and Pharmacokinetics

Clinical Trial Summary

This study is to test the safety, tolerability, pharmacokinetics (PK-the amount of study drug in the blood), and immunogenicity (how the study drug affects the immune system) of single dose and dose levels of an investigational drug called YQ23.

Clinical Trial Description

This is a first-in-man, phase 1, single-blind, randomized, placebo-controlled study in healthy volunteers. It will be conducted at a single centre and will enroll approximately 64 subjects. Subjects will either receive a single dose of study drug or placebo in a 3:1 ratio. Eight dose levels of YQ23 will be evaluated. Each dose level group will be divided into 2 cohorts, with each cohort being dosed at last 24 hours apart. The leading cohort will comprise of 2 subjects, with 1 subject receiving YQ23 and 1 subject receiving placebo. The remaining cohort will comprise of 6 subjects, with 5 receiving YQ23 and 1 receiving placebo. Safety assessments will be performed throughout the dosing and follow-up periods, and multiple PK samples will be collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03802292
Study type Interventional
Source New Beta Innovation Limited
Contact
Status Completed
Phase Phase 1
Start date January 16, 2019
Completion date November 20, 2020
View Details
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