Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04903730
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2021-05-24
Brief Title:
Safety Tolerability Pharmacokinetics Study of Single Multiple Inhaled Doses of Imatinib Inhalation Solution
Sponsor:
Aerami Therapeutics
Organization:
Aerami Therapeutics
Study Overview
Official Title:
A Randomised Double-Blind Placebo-Controlled Dose Escalation Study to Evaluate the Safety Tolerability and Pharmacokinetics of Single and Multiple Inhaled Doses of Imatinib Inhalation Solution AER-901 in Adult Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2022-12
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 randomised double-blind placebo-controlled dose escalation study to evaluate the safety tolerability and PK of single and multiple inhaled doses of imatinib inhalation solution AER-901 in healthy adult volunteers This study consists of 3 parts and an optional fourth part
Detailed Description:
This is a randomised double-blind placebo-controlled dose escalation study to evaluate the safety tolerability and PK of single and multiple inhaled doses of imatinib inhalation solution AER-901 in healthy adult volunteers This study consists of 3 parts and an optional fourth part
Part A double-blind placebo-controlled single ascending dose SAD
Part B double-blind placebo-controlled multiple ascending dose MAD
Part C optional open-label single-dose crossover The decision to proceed with Part C will be made by the Sponsor after reviewing unblinded safety and PK data from Part D of the study
Part D double-blind placebo-controlled 5 mg single dose SD followed by a twice daily BID 5 mg dose total daily dose of 10 mg of AER-901 in a propylene glycol formulation vs placebo
Oversight for the study will be provided by an SRC composed of the Principal Investigator PI the Sponsors Medical Monitor MM and an independent MM The decision to progress from Cohort A1 to Cohort A2 will be based on safety and tolerability data and not PK data from Cohort A1 However the decision to progress from Cohort A2 to Cohort A3 will be based on review of safety and tolerability data from Cohort A2 and PK data from Cohort A1 by the SRC A similar sequence will follow for subsequent progression decisions by the SRC for the cohorts in Part A and Part B of the study
All parts of the study A B C and D will include a 28-day Screening period a Treatment period and a Follow-up period Parts C and D include an additional treatment period and a Washout period between the 2 treatment periods
Throughout this Study Protocol timings for post-dose assessments for spirometry ECG blood and urine samples for PK analysis are stated in relation to completion of the most recent dose of IP
Part A double-blind placebo-controlled single ascending dose SAD
Part B double-blind placebo-controlled multiple ascending dose MAD
Part C optional open-label single-dose crossover The decision to proceed with Part C will be made by the Sponsor after reviewing unblinded safety and PK data from Part D of the study
Part D double-blind placebo-controlled 5 mg single dose SD followed by a twice daily BID 5 mg dose total daily dose of 10 mg of AER-901 in a propylene glycol formulation vs placebo
Oversight for the study will be provided by an SRC composed of the Principal Investigator PI the Sponsors Medical Monitor MM and an independent MM The decision to progress from Cohort A1 to Cohort A2 will be based on safety and tolerability data and not PK data from Cohort A1 However the decision to progress from Cohort A2 to Cohort A3 will be based on review of safety and tolerability data from Cohort A2 and PK data from Cohort A1 by the SRC A similar sequence will follow for subsequent progression decisions by the SRC for the cohorts in Part A and Part B of the study
All parts of the study A B C and D will include a 28-day Screening period a Treatment period and a Follow-up period Parts C and D include an additional treatment period and a Washout period between the 2 treatment periods
Throughout this Study Protocol timings for post-dose assessments for spirometry ECG blood and urine samples for PK analysis are stated in relation to completion of the most recent dose of IP
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