Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312423
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-28
Brief Title:
Safety and Pharmacokinetics of IMT504 an Immunomodulator and Tissue Repair Inducer
Sponsor:
Ministry of Public Health of the Province of La Rioja
Organization:
Ministry of Public Health of the Province of La Rioja
Study Overview
Official Title:
Phase 1 Open-label Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of IMT504 Phosphorothioate Oligonucleotide an Immunomodulator and Tissue Repair Inducer in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-03
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:
ECDA00002
Brief Summary:
Phase 1 open-label dose-escalation study to evaluate the safety and pharmacokinetics of IMT504 Phosphorothioate Oligonucleotide an immunomodulator and tissue repair inducer in healthy volunteers
Detailed Description:
This is a phase 1 open-label dose-escalation study to evaluate the safety and pharmacokinetics of IMT504 Phosphorothioate Oligonucleotide an immunomodulator and tissue repair inducer in healthy volunteers
A total of 12 adult volunteers of both sexes will be included who will be progressively incorporated into 3 groups of 4 volunteers each The first group will be administered subcutaneously with a single dose of 20 mg of IMT504 The second group will receive 3 doses 20 mg daily for 3 days and then if no toxicity is detected the last group will be administered 5 daily doses of 20 mgd
A total of 12 adult volunteers of both sexes will be included who will be progressively incorporated into 3 groups of 4 volunteers each The first group will be administered subcutaneously with a single dose of 20 mg of IMT504 The second group will receive 3 doses 20 mg daily for 3 days and then if no toxicity is detected the last group will be administered 5 daily doses of 20 mgd
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