Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2026-01-02 @ 5:54 AM
Study NCT ID:
NCT03802292
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2019-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First-In-Man, Healthy Volunteer Study to Evaluate Safety on the Use of YQ23
Sponsor:
New Beta Innovation Limited
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: