Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429930
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-21
Brief Title:
Safety Tolerability and Pharmacokinetics Study of L608 in Healthy Adults
Sponsor:
Pharmosa Biopharm Inc
Organization:
Pharmosa Biopharm Inc
Study Overview
Official Title:
A Phase 1 Randomized Double-blinded Placebo-controlled Study to Evaluate the Safety Tolerability and Pharmacokinetics of Single Ascending Doses of L608 for Inhalation in Healthy Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 the second single ascending dose study of L608 in healthy participants and is being conducted to evaluate the safety of L608 with higher dose levels starting from 20 μg and escalating up to a planned maximum dose of 110 μg
Detailed Description:
L608 inhalation Solution L608 is developed by Pharmosa Biopharm Inc PBI as a new liposomal Iloprost formulation for inhalation use in the treatment of patients with WHO Group 1 PAH As a liposomal formulation of iloprost L608 is intended to reduce the dosing frequency as well as provide sustained and selective release along with achieving therapeutically relevant iloprost level Meanwhile L608 is expected to mitigate burst release related local irritation and systemic side effects eg hypotension due to plasma peak in clinical practice
This Phase I randomized double-blinded placebo-controlled study will be conducted in healthy participants in New Zealand to evaluate the safety tolerability and pharmacokinetic of L608 The dose escalation design is applied in this study The sentinel dosing design will be applied for all cohorts
This Phase I randomized double-blinded placebo-controlled study will be conducted in healthy participants in New Zealand to evaluate the safety tolerability and pharmacokinetic of L608 The dose escalation design is applied in this study The sentinel dosing design will be applied for all cohorts
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