Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-03 @ 10:21 PM
Study NCT ID:
NCT02814656
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2016-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of AZD8871 in Healthy Subjects
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase I, Single Centre, Randomised, Single Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Inhaled AZD8871 in Healthy Male Subjects
Status:
COMPLETED
Status Verified Date:
2018-09
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:
AZD8871 is a new chemical entity possessing long-acting effect in a single molecule which presents a novel treatment approach to chronic obstructive pulmonary disease \[COPD\] and potentially also asthma (in combination with an inhaled corticosteroid \[ICS\]). The therapeutic goal for AZD8871 is a treatment with greater efficacy than single mechanism bronchodilators, with an equivalent or superior safety and tolerability profile. The primary purpose of this study is to check the safety and tolerability of AZD8871 at steady state. A multiple ascending dose (MAD) design has been selected for this study following the first time in man (FTIM), single ascending dose (SAD) study. Three dose levels will be tested in an ascending manner. The first dose to be administered will be 300 μg and the 2 subsequent doses will be decided based on safety, tolerability and pharmacokinetic (PK) data generated in the previous dose. The aim of this study is to also enable further investigations in healthy subjects to evaluate and develop AZD8871 as a dual action bronchodilator with an acceptable side-effect profile compared to other inhaled bronchodilators on the market as a treatment for COPD and asthma.
Detailed Description:
AZD8871 is a new chemical entity possessing long-acting dualpharmacology (muscarinic receptor antagonist and β2 adrenoceptor agonist \[MABA\]) in a single molecule. This type of agent presents a novel approach to the treatment of chronic obstructive pulmonary disease \[COPD\] and potentially also asthma (in combination with an inhaled corticosteroid \[ICS\]). AZD8871 is being developed for inhalation, formulated with alpha-lactose monohydrate and delivered by dry powder inhaler (DPI) that allows delivery of a single dose of the study drug. By combining this bi-functional activity, the therapeutic goal for AZD8871 is a treatment with greater efficacy than single mechanism bronchodilators, equivalent to long-acting β2-agonist (LABA) and long-acting muscarinic antagonist (LAMA) administered as free- or fixed-dose combination (FDC) therapies, with an equivalent or superior safety and tolerability profile. The current study will start with a single dose of 300 μg AZD8871 or placebo administered to 8 healthy subjects following a 3-day washout period, dosing will then continue for a further 12 days. Following the 1st cohort, 2 further cohorts of 8 subjects each will be administered multiple ascending doses (MAD) of AZD8871 in the same manner as Cohort 1. A MAD design has been selected for this study following the first time in man (FTIM), single ascending dose (SAD) study. Each subject will only be dosed in 1 cohort. The study design allows a gradual escalation of dose (Cohorts 2 and 3) with intensive safety monitoring to ensure the safety of the subjects. In Cohort 1, subjects will receive a single dose of AZD8871 300 μg or placebo on Day 1, followed by once daily dosing on Days 5 to 16. The dosing schedule of all cohorts will be single dose of IMP (active or placebo) on Day 1, followed by once daily dosing on Days 5 to 16. Within 5 to 7 days of discharge from the unit, there will be a Follow-up Visit. Dosing of Cohorts 2 and 3 will be preceded by a safety review committee (SRC) meeting, which will decide the exact dose to be given in the subsequent cohort. The dose escalation between cohorts will not exceed a multiple of 3 and the AZD8871 dose level in the study, for any cohort, will not exceed 2100 μg per day. The planned dose for Cohort 2 is either 600 or 900 μg, however the SRC may decide a different dose level. A minimum of 5 subjects on active treatment need to complete dosing per cohort in order to proceed to the next dose level. The aim of this study is to also enable further investigations in healthy subjects to evaluate and develop AZD8871 as a dual action bronchodilator with an acceptable side-effect profile compared to other inhaled bronchodilators on the market as a treatment for COPD and asthma.
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?: