Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-07-22 @ 9:35 AM
Study NCT ID:
NCT06438341
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-20
Brief Title:
Preliminary Evaluation of the Safety and Tolerability of SPOT-mRNA01 Subcutaneously Administered in Healthy Subjects
Sponsor:
Spot Biosystems Ltd
Organization:
Spot Biosystems Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Exploratory Clinical Study to Evaluate the Safety and Tolerability of SPOT-mRNA01 Injection in Healthy Adult Subjects
Status:
NOT_YET_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:
This is a first-in-human randomized double-blind placebo-controlled clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 injection in healthy adult volunteers
Detailed Description:
SPOT-mRNA01 collagen 1 alpha 1 COL1A1 mRNA-loaded EVs can induce collagen protein grafts in dermal tissue thereby supplementing collagen and reducing wrinkle formation in collagen-depleted skin Therefore SPOT-mRNA01 can provide a source of human collagen intradermally for cosmetic anti-aging use
This is a first-in-human randomized double-blind placebo-controlled single-dose dose ascending exploratory clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 administered by subcutaneous injection to healthy adult volunteers
This is a first-in-human randomized double-blind placebo-controlled single-dose dose ascending exploratory clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 administered by subcutaneous injection to healthy adult volunteers
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