Inhaled RB042 in Healthy Adult Volunteers, Healthy Adult Smokers and Patients With Chronic Obstructive Pulmonary Disease

ConditionsHealthy Healthy Smoker COPD (Chronic Obstructive Pulmonary Disease)COPD

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

Qualifiers

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

Treatments tested in this trial

RB042
Placebo inhalation solution

Treatment groups

105 Participants

are divided into 10 treatment groups

Treatment groups

See each treatment group below.

Sponsors and collaborators

Atisama Therapeutics

Lead sponsor

Source ClinicalTrials.gov