Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759365
Status:
TERMINATED
Last Update Posted:
2023-01-17
First Post:
2021-02-15
Brief Title:
Safety Tolerability Pharmacokinetic and Pharmacodynamic Study of Oral ASN51 in Healthy Subjects and Subjects With Alzheimers Disease
Sponsor:
Asceneuron Pty Ltd
Organization:
Asceneuron SA
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase 1 Safety Tolerability Pharmacokinetics and Pharmacodynamics Study of Oral ASN51 in Healthy Young Adult and Elderly Subjects and Elderly Subjects With Alzheimers Disease
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Delays with sites identifyingenrolling patients impact of COVID staffing and duration
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
ASN51-101 is a randomized double-blind placebo-controlled phase 1 first in human FIH safety tolerability pharmacokinetics PK and pharmacodynamics PD study of oral ASN51 in healthy young adult and elderly subjects and elderly subjects with AD The study is comprised of three parts Part 1 Part 2 and Part 3
Detailed Description:
Part 1
Five 5 single-ascending oral doses will be administered to 40 healthy adult male or female subjects aged 18-55 years inclusive Escalation to the next higher dose level may occur only after evaluation of the safety and PK results of the previous dose level at least 6 evaluable subjects Within each cohort 6 subjects will receive one dose of ASN51 and 2 subjects will receive one dose of matching placebo Based on this interim safety evaluation dose levels may be revised
Part 2
Multiple ascending oral doses will be administered to 24 healthy elderly subjects aged 55 - 80 years inclusive in 3 sequential dosing groups 8 subjects in each dosing group Six 6 subjects will receive ASN51 and two 2 subjects will receive matching placebo in each dosing group cohort for 10 days Escalation to the next higher dose level may occur only after evaluation of the safety and PK results of the previous dose level at least 6 evaluable subjects Based on this interim safety evaluation dose levels may be revised
Treatment of the subjects of each cohort will be administered as follows
Day 1 - 9 Twice daily BID dosing or once daily QD dosing to be defined after Part 1 SAD of ASN51 or placebo
Day 10 Only one dose will be administered in the morning of Day 10 Selection of the dosing regimen and dose levels to be administered in Part 2 will be made by the safety review committee SRC depending on the results of Part 1
Part 3
Multiple oral doses will be administered to 12 AD subjects aged 55-85 inclusive in a single dosing group for 10 days Eight 8 AD subjects will receive ASN51 and four 4 AD subjects will receive placebo in that dosing group cohort Selection of the dose level to be administered in Part 3 will be made by the SRC and will depend on the results of study Part 1 SAD and Part 2 MAD and will be below the maximum tolerated dose administered to healthy subjects in Part 2
Treatment of the AD subjects will be administered as follows
Day 1 - 9 Twice daily BID dosing or once daily QD dosing to be defined after Part 2 MAD of ASN51 or placebo
Day 10 Only one dose will be administered in the morning of Day 10 Selection of the dosing regimen and dose level to be administered in Part 3 will be made by the safety review committee SRC depending on the results of both Part 1 and Part 2
Five 5 single-ascending oral doses will be administered to 40 healthy adult male or female subjects aged 18-55 years inclusive Escalation to the next higher dose level may occur only after evaluation of the safety and PK results of the previous dose level at least 6 evaluable subjects Within each cohort 6 subjects will receive one dose of ASN51 and 2 subjects will receive one dose of matching placebo Based on this interim safety evaluation dose levels may be revised
Part 2
Multiple ascending oral doses will be administered to 24 healthy elderly subjects aged 55 - 80 years inclusive in 3 sequential dosing groups 8 subjects in each dosing group Six 6 subjects will receive ASN51 and two 2 subjects will receive matching placebo in each dosing group cohort for 10 days Escalation to the next higher dose level may occur only after evaluation of the safety and PK results of the previous dose level at least 6 evaluable subjects Based on this interim safety evaluation dose levels may be revised
Treatment of the subjects of each cohort will be administered as follows
Day 1 - 9 Twice daily BID dosing or once daily QD dosing to be defined after Part 1 SAD of ASN51 or placebo
Day 10 Only one dose will be administered in the morning of Day 10 Selection of the dosing regimen and dose levels to be administered in Part 2 will be made by the safety review committee SRC depending on the results of Part 1
Part 3
Multiple oral doses will be administered to 12 AD subjects aged 55-85 inclusive in a single dosing group for 10 days Eight 8 AD subjects will receive ASN51 and four 4 AD subjects will receive placebo in that dosing group cohort Selection of the dose level to be administered in Part 3 will be made by the SRC and will depend on the results of study Part 1 SAD and Part 2 MAD and will be below the maximum tolerated dose administered to healthy subjects in Part 2
Treatment of the AD subjects will be administered as follows
Day 1 - 9 Twice daily BID dosing or once daily QD dosing to be defined after Part 2 MAD of ASN51 or placebo
Day 10 Only one dose will be administered in the morning of Day 10 Selection of the dosing regimen and dose level to be administered in Part 3 will be made by the safety review committee SRC depending on the results of both Part 1 and Part 2
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