Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04505137
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2020-07-31
Brief Title:
A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy Volunteers
Sponsor:
Gmax Biopharm Australia Pty Ltd
Organization:
Gmax Biopharm LLC
Study Overview
Official Title:
A Phase 1 Placebo-Controlled Double-Blind Dose-Escalation Study To Investigate The Safety Tolerability And Pharmacokinetics Of A Single Intravenous Dose Of GMA301 Injection In Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2020-11
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 a single-centre randomized double-blind placebo-controlled dose escalation study to assess the safety tolerability and PK of GMA301 Injection in healthy subjects Two sequential dosing cohorts at ascending dose fashion each with 6 subjects receiving GMA301 Injection and 2 subjects receiving placebo total of 16 subjects will be given single doses The doses to be administered in the two cohorts will be 1500 mg and 2000 mg respectively or matching placebo
Detailed Description:
The current study is an extension of the previous study 1010218 ACTRN12618000121268 to further explore the safety and PK profile of GMA301 injection at higher dosage The SRC Safety Review Committee will be responsible for the assessment of safety tolerability and PK data for each dose level and to make decisions with regards to study progression A Statistical Analysis Plan SAP will be written after finalizing the protocol and prior to database lock The SAP will detail the implementation of all the planned statistical analyses in accordance with the principal features stated in the protocol Adverse events will be coded using the Medical Dictionary for Regulatory Activities MedDRA
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