A Trial to Assess Safety, Tolerability, and Pharmacokinetics of AN01 Inhalation Powder in Healthy Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAirNexis Therapeutics, Inc.
About this trial
AN01 is a selective small-molecule dual inhibitor of phosphodiesterase 3 and 4 (PDE3/4).
As a potential new therapy for COPD, AN01 is expected to serve either as a monotherapy for COPD or as adjunctive therapy to current inhaled standard treatments, potentially generating synergistic complementary effects in patients requiring additional therapeutic options.
The primary objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of AN01 in healthy participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults ≥18 and ≤60 years (inclusive).
Body Mass Index (BMI) ≥18 and ≤32 kg/m2 (inclusive).
Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, spirometry, and electrocardiogram (ECG).
Non-smokers or former smokers who have quit for ≥2 years with a prior smoking history of <5 pack-years (pack-years defined as = cigarettes per day × years smoked; 1 pack = 20 cigarettes).
Disqualifiers
History of clinically significant (as per Investigator's judgment) upper respiratory disease or history of any significant pulmonary disease including, but not limited to, asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, and history of previous tuberculosis exposure with positive interferon gold test (without actual infection).
Participants with any history of, or active, clinically significant disease (e.g., cardiovascular disease, chronic liver disease, psychiatric medical history, renal disease) that could interfere with the interpretation of the study results or compromise the health of the participant based on the judgment of the Investigator.
Administration of vaccines/immunizations and/or boosters within 8 days prior to first dosing or if planned during the study.
Any history of active infection at the time of Screening and/or within 28 days prior to first dosing.
Trial design
Design model
Parallel
Treatments tested in this trial
AN01
DrugActive study drug
Placebo
DrugPlacebo
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: AN01Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence, severity, relationship to the investigational drug, and types of adverse events and serious adverse events
Time frame
Day 1 - Day 142
Number of participants with abnormal clinically significant physical examination (PE) results following study drug administration
Time frame
Day 1 - Day 143
Number of participants with abnormal clinically significant vital signs following study drug administration
Time frame
Day 1 - Day 144
Number of participants with abnormal clinically significant clinical laboratory results following study drug administration
Time frame
Day 1 - Day 14Secondary outcomes
1
PK parameter assessed by serum AN01 concentration at specified timepoints for area under curve (AUC)
Time frame
Day 1 - Day 92
PK parameter assessed by serum AN01 concentration at specified timepoints for maximum plasma concentration (Cmax)
Time frame
Day 1 - Day 93
PK parameter assessed by serum AN01 concentration at specified timepoints for time to peak concentration (Tmax)
Time frame
Day 1 - Day 94
PK parameter assessed by serum AN01 concentration at specified timepoints for terminal elimination half life (t1/2)
Time frame
Day 1 - Day 9Sponsors and contacts
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Source ClinicalTrials.gov