Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-26 @ 2:35 PM
Study NCT ID:
NCT06283459
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2024-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety & Immunogenicity of IMNN-101 Administered in Healthy Adults Previously Vaccinated Against SARS-CoV-2
Sponsor:
Imunon
Organization:
Study Overview
Official Title:
Phase 1/2, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of a DNA Vaccine, IMNN-101, Administered as a Single Dose in Healthy Adults Previously Vaccinated Against SARS-CoV-2
Status:
COMPLETED
Status Verified Date:
2025-07
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 an open-label phase 1/2, dose-escalation study. Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle and will be followed through 12 months post-vaccination (through Study Day 365).
Detailed Description:
This is an open-label phase 1/2, dose-escalation study. Participants will receive a single intramuscular (IM) dose of IMNN-101 on Day 0 in the deltoid muscle and will be followed through 12 months post-vaccination (through Study Day 365).
Phase 1: A total of twenty-four (24) participants will be enrolled into one of three groups listed below:
Group 1 (8 participants) - 0.25 mL at 2 mg/ml of IMNN-101 DNA to be administered as 0.5 mg dose intramuscularly (IM) at Day 0
Group 2 (8 participants) - 0.50 mL at 2 mg/ml of IMNN-101 DNA to be administered as 1.0 mg dose intramuscularly (IM) at Day 0
Group 3 (8 participants) - 1.0 mL at 2 mg/ml of IMNN-101 DNA to be administered as 2.0 mg dose intramuscularly (IM) at Day 0
To assess early safety signals for this Phase 1 study, vaccination will proceed in a staged fashion. Sentinel participant dosing will begin with 4 participants in Group 1 (0.25 mL). If no halting rules have been met after Group 1 sentinels complete Day 7, then the remaining 4 participants in Group 1 may enroll and sentinel dosing will begin with 4 participants in Group 2 (0.5 mL). If no halting rules have been met after Group 2 sentinels complete Day 7, then the remaining 4 participants in Group 2 may enroll and sentinel dosing will begin with 4 participants in Group 3 (1.0 mL). If no halting rules have been met after Group 3 sentinels complete Day 7, then the remaining 4 participants in Group 3 may enroll.
Phase 2: Once a review of the safety and immunogenicity is completed in Phase 1 then an expansion Phase 2 will commence utilizing the recommended Phase 2 dose (RP2D). Fifty (50) healthy participants meeting eligibility criteria will be enrolled.
Phase 1: A total of twenty-four (24) participants will be enrolled into one of three groups listed below:
Group 1 (8 participants) - 0.25 mL at 2 mg/ml of IMNN-101 DNA to be administered as 0.5 mg dose intramuscularly (IM) at Day 0
Group 2 (8 participants) - 0.50 mL at 2 mg/ml of IMNN-101 DNA to be administered as 1.0 mg dose intramuscularly (IM) at Day 0
Group 3 (8 participants) - 1.0 mL at 2 mg/ml of IMNN-101 DNA to be administered as 2.0 mg dose intramuscularly (IM) at Day 0
To assess early safety signals for this Phase 1 study, vaccination will proceed in a staged fashion. Sentinel participant dosing will begin with 4 participants in Group 1 (0.25 mL). If no halting rules have been met after Group 1 sentinels complete Day 7, then the remaining 4 participants in Group 1 may enroll and sentinel dosing will begin with 4 participants in Group 2 (0.5 mL). If no halting rules have been met after Group 2 sentinels complete Day 7, then the remaining 4 participants in Group 2 may enroll and sentinel dosing will begin with 4 participants in Group 3 (1.0 mL). If no halting rules have been met after Group 3 sentinels complete Day 7, then the remaining 4 participants in Group 3 may enroll.
Phase 2: Once a review of the safety and immunogenicity is completed in Phase 1 then an expansion Phase 2 will commence utilizing the recommended Phase 2 dose (RP2D). Fifty (50) healthy participants meeting eligibility criteria will be enrolled.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: