This is a 4-part, randomised, double-blind, placebo-controlled, first in human study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of inhaled RB042.
The purpose of this study is to measure the safety, tolerability, PK, and PD of inhaled RB042 compared with inhaled placebo in healthy adult volunteers, healthy adult smokers and patients with moderate to severe chronic obstructive pulmonary disease. Study details include: * Overall study duration of up to 19 months. * Participants in Part A (healthy adult volunteers) will be required to visit the study site for assessments on 11 occasions, including a 4-day in-house stay, over 4 months. * Participants in Parts B will be required to visit the study site for assessments on 13 occasions, including a 17-day (Day -1 to 16) and 3-day (Day 21 to 24) in-house stay, over 5 months. * Participants in Part C will be required to visit the study site for assessments on 10 occasions, including in-house stays between Day -1 to 2, Day 7 to 8, Day 14 to 15, Day 21 to 23 over 5 months. * Patients in Part D will be required to visit the study site for assessments on 10 occasions over 5 months. * Participants will be administered a single dose (Part A) or multiple doses (Parts B, C and D) of study intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
A single or multiple doses of RB042 will be administered via a nebuliser.
A single or multiple doses of placebo will be administered via a nebuliser.
Linear Clinical Research
Nedlands, Western Australia, Australia
RECRUITINGNumber and frequency of treatment-emergent adverse events (TEAEs)
To assess the safety and tolerability of single and multiple doses of RB042 when administered via a nebuliser to healthy adult volunteers, healthy adult smokers and patients with moderate to severe stable COPD.
Time frame: From Day 1 until the end of the study (Day 85 for Part A; Day 106 for Parts B and D)
Maximum concentration (Cmax)
To characterize the Cmax of RB042 following single and multiple doses of RB042 administered via a nebuliser to healthy adult volunteers, healthy adult smokers and patients with moderate to severe stable COPD.
Time frame: From Day 1 until the end of the study (Day 85 for Part A; Day 106 for Parts B and D)
Time to maximum concentration (Tmax)
To characterize the Tmax of RB042 following single and multiple doses of RB042 administered via a nebuliser to healthy adult volunteers, healthy adult smokers and patients with moderate to severe stable COPD.
Time frame: From Day 1 until the end of the study (Day 85 for Part A; Day 106 for Parts B and D)
Terminal elimination half-life (t½)
To characterize the t½ of RB042 following single and multiple doses of RB042 administered via a nebuliser to healthy adult volunteers, healthy adult smokers and patients with moderate to severe stable COPD.
Time frame: From Day 1 until the end of the study (Day 85 for Part A; Day 106 for Parts B and D)
Area under the concentration-time curve (AUC)
To characterize the AUC of RB042 following single and multiple doses of RB042 administered via a nebuliser to healthy adult volunteers, healthy adult smokers and patients with moderate to severe stable COPD.
Time frame: From Day 1 until the end of the study (Day 85 for Part A; Day 106 for Parts B and D)
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Trough concentration
To characterize the AUC of RB042 following multiple doses of RB042 administered via a nebuliser to healthy adult volunteers, healthy adult smokers and patients with moderate to severe stable COPD.
Time frame: On Days 7, 14, and 21