Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2026-02-03 @ 3:17 AM
Study NCT ID:
NCT02022761
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2013-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of Inhaled Laninamivir Octanoate TwinCaps® DPI in Adults With Chronic Asthma
Sponsor:
Biota Scientific Management Pty Ltd
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Inhaled Laninamivir Octanoate in Adults With Chronic Asthma
Status:
COMPLETED
Status Verified Date:
2018-05
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 a single centre, randomized, double-blind, placebo-controlled, single ascending dose study, in which the safety and pharmacokinetics of laninamivir octanoate administered by inhalation via the TwinCaps® DPI will be assessed in adults with mild or moderate chronic asthma.
Detailed Description:
32 subjects, as two sequential groups of 16 subjects at each dose level (40 mg and 80 mg), will be randomised 3:1 to receive active drug or matching placebo.
Males and females aged 18 to 65 years inclusive, with mild or moderate chronic asthma.
Stratum 1: Mild asthma - requiring treatment consistent with Global Initiative for Asthma (GINA) Step 2 Stratum 2: Moderate asthma - requiring treatment consistent with GINA Step 3
Following a screening period of up to 30 days, eligible consenting subjects will be admitted to the clinic on the morning of Day 1. Laninamivir octanoate will be administered on Day 1. Subjects will remain in the clinic until Day 3 and will return for subsequent outpatient visits on Day 5, Day 6 and Day 7. A final follow-up visit for safety evaluations will occur on Day 14 ± 1 (or at the time of premature discontinuation). Each subject will participate in the study for approximately 7 weeks.
Males and females aged 18 to 65 years inclusive, with mild or moderate chronic asthma.
Stratum 1: Mild asthma - requiring treatment consistent with Global Initiative for Asthma (GINA) Step 2 Stratum 2: Moderate asthma - requiring treatment consistent with GINA Step 3
Following a screening period of up to 30 days, eligible consenting subjects will be admitted to the clinic on the morning of Day 1. Laninamivir octanoate will be administered on Day 1. Subjects will remain in the clinic until Day 3 and will return for subsequent outpatient visits on Day 5, Day 6 and Day 7. A final follow-up visit for safety evaluations will occur on Day 14 ± 1 (or at the time of premature discontinuation). Each subject will participate in the study for approximately 7 weeks.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: