NCT03802292

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: New Beta Innovation Limited · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	YQ23	Single dose of YQ23 delivered via intravenous route. Ascending dose levels will be evaluated
BIOLOGICAL	Matching Placebo	Single dose of the matching placebo delivered via intravenous route.

Timeline

• Start date: 2019-01-16
• Primary completion: 2020-09-20
• Completion: 2020-11-20
• First posted: 2019-01-14
• Last updated: 2021-03-03

Locations

1 site across 1 country: United Kingdom