Cystic Fibrosis (CF) Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of AIR-DNase When Administered by Inhalation to Healthy Adult Subjects
This study will be performed to assess the safety, tolerability and PK of escalating inhaled
AIR-DNase doses administered as a single dose followed by multiple doses for 5 consecutive
days in healthy subjects.
A thorough review of safety data will be conducted after completion of each dose level per
subject and prior to both, moving to the next dose level in Part 1 and commencement of the
multiple dose Part 2.
This is a Phase I study to evaluate the safety, tolerability and pharmacokinetics of inhaled
AIR DNase in healthy volunteers. Up to 18 healthy males subjects (age 18 -55 inclusive) will
be randomized to one of three dose cohorts (up to 6 subjects per cohort), receiving AIR
DNase doses equivalent to 1.25 mg, 2.5mg or 5 mg or placebo in accordance. Subjects
randomized to one of the cohorts will receive either active of placebo as single dose, in
continuation, following safety assessments, will receive multiple doses, once daily for 5
consecutive days. Subjects will remain at the clinical center for 8 hours after the single
administration of AIR DNase/placebo including PK sampling. During the multiple dosing
subjects will arrive at the clinical center daily for AIR DNase/placebo administrations and
study procedures and remain at the site for 4 hours post dosing.
Follow up visits will be performed 7±2 days following single administration and 7±2 days
following the last administration of the multiple phase.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT04853368 -
Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Adult Participants With Cystic Fibrosis
|
Phase 2 | |
| Terminated |
NCT03234387 -
A CFit Study - Baseline
|
||
| Completed |
NCT03445793 -
: TRANSITION: An Observational Study of Transition From Lumacaftor/Ivacaftor to Tezacaftor/Ivacaftor (Tez/Iva)
|
||
| Completed |
NCT02778750 -
Evaluation Of The Pan-microbiome and Host Immune Response in CF
|
||
| Completed |
NCT00677365 -
Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
|
Phase 2 | |
| Terminated |
NCT03597347 -
Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection
|
Phase 2 | |
| Recruiting |
NCT05818319 -
Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/Tezacaftor/Ivacaftor in Urine After a Short Pause of Therapy
|
N/A | |
| Completed |
NCT04375878 -
OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis
|
Phase 2 | |
| Withdrawn |
NCT01951833 -
Long Term Significance (Survival) of LCI in Patients With Cystic Fibrosis
|
N/A | |
| Completed |
NCT03746483 -
OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
|
Phase 2 | |
| Completed |
NCT02163681 -
MRI for Non-Invasive Imaging in Neonates and Children
|
N/A | |
| Completed |
NCT02036879 -
Gender Disparity and Hormones in Cystic Fibrosis
|
Early Phase 1 | |
| Recruiting |
NCT01851642 -
Lung Disease and Its Affect on the Work of White Blood Cells in the Lungs
|