Viewing Study NCT04415671



Ignite Creation Date: 2024-05-06 @ 2:45 PM
Last Modification Date: 2024-10-26 @ 1:36 PM
Study NCT ID: NCT04415671
Status: COMPLETED
Last Update Posted: 2022-05-06
First Post: 2020-05-27

Brief Title: Phase 1 Safety Tolerability PK PD Study of AD-214 Administered to Healthy Volunteers
Sponsor: AdAlta Limited
Organization: AdAlta Limited

Study Overview

Official Title: A Phase 1 Dose-escalating Study of the Safety Tolerability and Pharmacokinetics of Single and Repeat Doses of AD-214 When Administered Intravenously to Healthy Volunteers
Status: COMPLETED
Status Verified Date: 2022-05
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 is a first in human FIH multi-center dose escalating study to evaluate the safety tolerability pharmacokinetics PK pharmacodynamics PD and immunogenicity of AD-214 when administered to healthy volunteers HVs The study in HVs will be a randomized double blind and placebo-controlled single ascending dose SAD and multiple ascending dose MAD Part B study
Detailed Description: None

Study Oversight

Has Oversight DMC: None
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?: None