Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309667
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-02-14
Brief Title:
A Study to Assess Safety Pharmacokinetics and Pharmacodynamics of PG-102MG12 in Healthy Volunteers
Sponsor:
ProGen Co Ltd
Organization:
ProGen Co Ltd
Study Overview
Official Title:
A Double-blind Randomized Placebo Controlled Combined Single and Multiple Ascending Dose Phase 1 Study to Investigate the Safety Tolerability and Pharmacokinetic and Pharmacodynamics of PG-102MG12 in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-02
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 Phase 1 first-in-human FIH randomized double-blind placebo-controlled combined single Part A multiple Part B ascending dose phase 1 study to investigate the safety tolerability and pharmacokinetic and pharmacodynamics following subcutaneous injections of PG-102MG12 in healthy adult participants
This study will be conducted in 2 Parts Part A and B with up to 5 cohorts in each part Part A Cohorts A1 to A5 and Part B Cohorts B1 to B5
This study will be conducted in 2 Parts Part A and B with up to 5 cohorts in each part Part A Cohorts A1 to A5 and Part B Cohorts B1 to B5
Detailed Description:
Part A SAD
In Part A subjects will receive a single dose of study drug and the safety and efficacy of PG-102MG12 will be evaluated in healthy subjects
Part B MAD
In Part B subjects will receive once-weekly doses of the study drug for 4 weeks and the safety and efficacy of PG-102MG12 will be evaluated in otherwise healthy overweight adult subjects
In Part A subjects will receive a single dose of study drug and the safety and efficacy of PG-102MG12 will be evaluated in healthy subjects
Part B MAD
In Part B subjects will receive once-weekly doses of the study drug for 4 weeks and the safety and efficacy of PG-102MG12 will be evaluated in otherwise healthy overweight adult subjects
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