Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05748119
Status:
UNKNOWN
Last Update Posted:
2023-02-28
First Post:
2022-10-31
Brief Title:
A Study to Assess the Safety of MEB-1170 in Healthy Subjects
Sponsor:
Mebias Discovery Inc
Organization:
Mebias Discovery Inc
Study Overview
Official Title:
A Phase I Double-Blind Placebo-Controlled Single and Multiple Oral Ascending Dose Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of MEB-1170 in Healthy Subjects
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
RECRUITING
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:
Primary Objective To determine the safety and tolerability of single and multiple ascending oral doses of MEB-1170 in healthy subjects
Secondary Objectives
1 To determine the single and multiple oral dose pharmacokinetic profiles of MEB-1170 and the primary metabolite M373 in healthy subjects
2 To determine the effect of food on the pharmacokinetic PK profile of a single oral dose of MEB-1170 in healthy subjects
3 To assess the pharmacodynamic PD response following single and multiple oral doses of MEB-1170
Secondary Objectives
1 To determine the single and multiple oral dose pharmacokinetic profiles of MEB-1170 and the primary metabolite M373 in healthy subjects
2 To determine the effect of food on the pharmacokinetic PK profile of a single oral dose of MEB-1170 in healthy subjects
3 To assess the pharmacodynamic PD response following single and multiple oral doses of MEB-1170
Detailed Description:
Study Design This will be a double-blind placebo-controlled single and multiple oral dose study conducted in two parts
Part A SADFE
Part A will comprise a single ascending dose SAD sequential cohort study incorporating a food effect FE evaluation Up to 40 subjects will be studied in 5 cohorts Cohorts A1 to A5 each cohort consisting of 8 subjects 6 treated with MEB-1170 2 treated with placebo
Subjects in Cohorts A1 A2 A4 and A5 will participate in 1 treatment period only residing at the CRU from Day -1 the day before dosing to Day 3 48 hours postdose Subjects in Cohort A3 will participate in 2 treatment periods once in fasted state once in fed state separated by a minimum of 6 days All subjects will return for a poststudy visit approximately 5 to 7 days after their final dose
Each Cohort will include sentinel dosing such that two subjects one active and one placebo will be dosed at least 48 hours before the remaining subjects in the cohort Continuation to dose the remaining subjects will be at the Investigators discretion in consultation with the Sponsor
All doses will be administered in accordance with a randomization schedule in the fasted state in the morning of Day 1 except for Cohort A3 Treatment Period 2 where MEB-1170 will be given 30 minutes after start of a high fat breakfast see below Each subject in Cohorts A1 A2 A4 and A5 will receive only a single dose of MEB-1170 or placebo during the study
Subjects in Cohort A3 will participate in a 2-period treatment design in which they will be assessed for both the single-dose of MEB-1170 in a Fed and in a Fasted condition Subjects will receive the same treatment ie either MEB-1170 or placebo in both Period 1 and Period 2 and thus subjects will receive either two single doses of MEB-1170 or two single doses of placebo during the study Fasting state assessments will occur in Period 1 and Fed state assessments in Period 2
SAD Assessments
Safetytolerability throughout study
Physical examination vital signs clinical laboratory findings and ECG
PK concentrations
PD assessments pupillometry capnography oximetry cold pressor testing
Following the completion of each cohort a safety and tolerability review will be conducted by the Safety Review Committee SRC see below prior to proceeding to the next cohort Based on this review a decision may be made to continue the study as planned repeat the same dose in another Cohort assess a lower dose add an intermediate dose or terminate the study Additionally if no dose limiting toxicities are seen further cohorts at higher doses may be added
Part B MAD
Part B will comprise a multiple ascending dose MAD sequential cohort study This part will be initiated after the first three SAD cohorts have been fully evaluated for safety and tolerability and the SRC has concluded that the MAD portion may commence Up to 32 subjects will be studied in 4 cohorts Cohorts B1 to B4 each cohort consisting of 8 subjects
In each of Cohorts B1 to B4 6 subjects will receive MEB-1170 and 2 will receive placebo Once-daily dosing will occur on Days 1 to 7 inclusive for all subjects Each subject will participate in 1 treatment period only residing at the CRU from the evening of Day -1 the day before dosing until the morning of Day 9 48 hours after the final dose on Day 7
All subjects will return for a poststudy visit 6 to 8 days after their final dose for a final safety assessment
Dose levels to be studied will be determined following review of data from Part A Following completion of each cohort in Part B a safety and tolerability review will be conducted by the SRC prior to proceeding to the next cohort see below Based on this review a decision may be made to continue the study as planned repeat the same dose in another Cohort assess a lower dose add an intermediate dose or terminate the study Additionally if no dose limiting toxicities are seen further cohorts at higher doses may be added
MAD Assessments
Safetytolerability throughout study
Physical examinations vital signs clinical laboratory findings and ECG
PK concentration see Schedule of Assessments for details
PD assessments pupillometry capnography cold pressor testing oximetry
Reference Therapy Dose and Mode of Administration
Matching placebo capsule administered orally
Part A SADFE
Part A will comprise a single ascending dose SAD sequential cohort study incorporating a food effect FE evaluation Up to 40 subjects will be studied in 5 cohorts Cohorts A1 to A5 each cohort consisting of 8 subjects 6 treated with MEB-1170 2 treated with placebo
Subjects in Cohorts A1 A2 A4 and A5 will participate in 1 treatment period only residing at the CRU from Day -1 the day before dosing to Day 3 48 hours postdose Subjects in Cohort A3 will participate in 2 treatment periods once in fasted state once in fed state separated by a minimum of 6 days All subjects will return for a poststudy visit approximately 5 to 7 days after their final dose
Each Cohort will include sentinel dosing such that two subjects one active and one placebo will be dosed at least 48 hours before the remaining subjects in the cohort Continuation to dose the remaining subjects will be at the Investigators discretion in consultation with the Sponsor
All doses will be administered in accordance with a randomization schedule in the fasted state in the morning of Day 1 except for Cohort A3 Treatment Period 2 where MEB-1170 will be given 30 minutes after start of a high fat breakfast see below Each subject in Cohorts A1 A2 A4 and A5 will receive only a single dose of MEB-1170 or placebo during the study
Subjects in Cohort A3 will participate in a 2-period treatment design in which they will be assessed for both the single-dose of MEB-1170 in a Fed and in a Fasted condition Subjects will receive the same treatment ie either MEB-1170 or placebo in both Period 1 and Period 2 and thus subjects will receive either two single doses of MEB-1170 or two single doses of placebo during the study Fasting state assessments will occur in Period 1 and Fed state assessments in Period 2
SAD Assessments
Safetytolerability throughout study
Physical examination vital signs clinical laboratory findings and ECG
PK concentrations
PD assessments pupillometry capnography oximetry cold pressor testing
Following the completion of each cohort a safety and tolerability review will be conducted by the Safety Review Committee SRC see below prior to proceeding to the next cohort Based on this review a decision may be made to continue the study as planned repeat the same dose in another Cohort assess a lower dose add an intermediate dose or terminate the study Additionally if no dose limiting toxicities are seen further cohorts at higher doses may be added
Part B MAD
Part B will comprise a multiple ascending dose MAD sequential cohort study This part will be initiated after the first three SAD cohorts have been fully evaluated for safety and tolerability and the SRC has concluded that the MAD portion may commence Up to 32 subjects will be studied in 4 cohorts Cohorts B1 to B4 each cohort consisting of 8 subjects
In each of Cohorts B1 to B4 6 subjects will receive MEB-1170 and 2 will receive placebo Once-daily dosing will occur on Days 1 to 7 inclusive for all subjects Each subject will participate in 1 treatment period only residing at the CRU from the evening of Day -1 the day before dosing until the morning of Day 9 48 hours after the final dose on Day 7
All subjects will return for a poststudy visit 6 to 8 days after their final dose for a final safety assessment
Dose levels to be studied will be determined following review of data from Part A Following completion of each cohort in Part B a safety and tolerability review will be conducted by the SRC prior to proceeding to the next cohort see below Based on this review a decision may be made to continue the study as planned repeat the same dose in another Cohort assess a lower dose add an intermediate dose or terminate the study Additionally if no dose limiting toxicities are seen further cohorts at higher doses may be added
MAD Assessments
Safetytolerability throughout study
Physical examinations vital signs clinical laboratory findings and ECG
PK concentration see Schedule of Assessments for details
PD assessments pupillometry capnography cold pressor testing oximetry
Reference Therapy Dose and Mode of Administration
Matching placebo capsule administered orally
Study Oversight
Has Oversight DMC:
None
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?:
None