Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06259903
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-01-29
Brief Title:
Subcutaneous Administration of MD-18 in Healthy Subjects
Sponsor:
Cohen Global Ltd
Organization:
Cohen Global Ltd
Study Overview
Official Title:
A Single Center Single Dose Double-blind Randomized Placebo-Controlled Dose-Escalating Study to Evaluate Safety Tolerability and Pharmacokinetics of Subcutaneously Administered MD-18 in Healthy Subjects
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
A Single Center Single Dose Double-blind Randomized Placebo-controlled Dose-Escalating Study to Evaluate Safety Tolerability and Pharmacokinetics of Subcutaneously Administered MD-18 in healthy subjects
Detailed Description:
This study will be conducted as a single-center study A single escalating dose of MD-18 will be administered to each subject with a seven-day follow-up 35 subjects will be enrolled Cohorts will receive doses of 40 80 160 240 or 320 milligram of MD-18 using 52 active placebo randomization Sentinel dosing will be used consisting of enrolling three subjects at a 21 active to placebo ratio followed by the remaining subjects in the respective dose cohorts enrolled 48 hours later Each of the 5 dose cohorts will enroll five active and two placebo subjects with a total of 25 subjects receiving active therapy across the 5 arms and 10 subjects receiving placebo The study will be conducted on an in-patient basis for the first 24 hours followed by discharge and telephone check-in at 48 and 72 hours and return for follow-up visit at 7 days after administration of a single dose of MD-18
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