Ignite Creation Date:
2024-07-17 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493045
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-29
Brief Title:
First-In-Human FIH Trial Evaluating the Safety and Tolerability of Single and Multiple Ascending Oral Doses of IRL757 in Healthy Volunteers
Sponsor:
Integrative Research Laboratories AB
Organization:
Integrative Research Laboratories AB
Study Overview
Official Title:
A Prospective Single-centre Randomised Double-blind Placebo-controlled Phase I First-In-Human FIH Trial Evaluating the Safety and Tolerability of Single and Multiple Ascending Oral Doses of IRL757 in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-07
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 a Phase 1 First-In-Human study evaluating the safety and tolerability of single and multiple ascending oral doses of IRL757 in healthy volunteers
Detailed Description:
The trial is composed of two parts Single Ascending Dose SAD part and Multiple Ascending Dose MAD part
The SAD part of the trial will be a parallel group design with one pre-defined starting dose and up to four tentative ascending dose levels of IRL757 Eligible and consenting participants will be included in one of five cohorts with 8 participants in each cohort ratio 13 placeboIRL757
The MAD part of the trial will start after completion of the SAD part of the trial Depending on the data from the SAD part two or three dose levels will be evaluated in the MAD part of the trial There will be 12 participants in each cohort ratio 13 placeboIRL757
At the screening visit consenting subjects will be screened for eligibility according to study specific inclusionexclusion criteria within 4 weeks before Investigational Medicinal Product IMP administration
If eligible participants will be admitted to the phase 1 clinic for allocation and administration of the IMP single dose in the SAD part of the trial or repeated dose treatment administered repeatedly for 10 days in the MAD part of the trial Participants will receive IRL757 or placebo as randomized
The treatment allocation will be double-blind ie it will not be disclosed to the patients the site staff or the Sponsor
A follow-up visit will be performed for all participants 5-10 days after IMP administration
Safety assessments will be performed throughout the study review and collection of adverse events physical examination suicidality ideation electrocardiogram recording vital signs safety laboratory assessments Blood and urine sampling will also be performed for determination of pharmacokinetic parameters
The SAD part of the trial will be a parallel group design with one pre-defined starting dose and up to four tentative ascending dose levels of IRL757 Eligible and consenting participants will be included in one of five cohorts with 8 participants in each cohort ratio 13 placeboIRL757
The MAD part of the trial will start after completion of the SAD part of the trial Depending on the data from the SAD part two or three dose levels will be evaluated in the MAD part of the trial There will be 12 participants in each cohort ratio 13 placeboIRL757
At the screening visit consenting subjects will be screened for eligibility according to study specific inclusionexclusion criteria within 4 weeks before Investigational Medicinal Product IMP administration
If eligible participants will be admitted to the phase 1 clinic for allocation and administration of the IMP single dose in the SAD part of the trial or repeated dose treatment administered repeatedly for 10 days in the MAD part of the trial Participants will receive IRL757 or placebo as randomized
The treatment allocation will be double-blind ie it will not be disclosed to the patients the site staff or the Sponsor
A follow-up visit will be performed for all participants 5-10 days after IMP administration
Safety assessments will be performed throughout the study review and collection of adverse events physical examination suicidality ideation electrocardiogram recording vital signs safety laboratory assessments Blood and urine sampling will also be performed for determination of pharmacokinetic parameters
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