Inhaled RB042 in Healthy Adult Volunteers, Healthy Adult Smokers and Patients With Chronic Obstructive Pulmonary Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAtisama Therapeutics
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Part A, B, C only: Participants must be 18 to 55 years of age inclusive.
Part D only: Patients must be 40 to 80 years of age inclusive.
Part A, B, C only: Participants must be overtly healthy as determined by medical evaluation.
Part C only: have a ≥10 pack years smoking history, have smoked tobacco products (cigarettes, cigars, or equivalent) regularly for the past 12 months, and currently smoke daily.
Disqualifiers
Part A, B and C only: Clinically significant history or presence of gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, neurologic, hematologic, metabolic, autoimmune, or oncologic disorders that may affect safety or study outcomes.
Part D only: Current unstable clinically significant history or presence of gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, neurologic, hematologic, metabolic, autoimmune, or oncologic disorders that may affect safety or study outcomes.
Part A, B and C only: Chronic or active respiratory disease (e.g., asthma, COPD) or history of angioedema within 3 years.
Part D only: Patients with other respiratory conditions other than COPD (for example, clinically significant asthma, active tuberculosis, pulmonary fibrosis) are excluded if these conditions are the primary cause of their respiratory symptoms.
Trial design
Design model
Parallel
Treatments tested in this trial
RB042
DrugA single or multiple doses of RB042 will be administered via a nebuliser.
Placebo inhalation solution
DrugA single or multiple doses of placebo will be administered via a nebuliser.
Treatment groups
105 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Group A: Cohort A1Experimental treatment 2 interventions
Group B: Cohort A2Experimental treatment 2 interventions
Group C: Cohort A3Experimental treatment 2 interventions
Group D: Cohort A4Experimental treatment 2 interventions
Group E: Cohort B1Experimental treatment 2 interventions
Group F: Cohort B2Experimental treatment 2 interventions
Group G: Cohort B3Experimental treatment 2 interventions
Group H: Cohort B4Experimental treatment 2 interventions
Group I: Cohort C1Experimental treatment 2 interventions
Group J: Cohort D1Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number 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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
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Source ClinicalTrials.gov