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NCT05712538
Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects
Conditions: Cystic Fibrosis
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 32
Sponsor: Arcturus Therapeutics, Inc.
Location: New Zealand
Summary
Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-032 in healthy adult subjects.
Eligibility Criteria
Key Inclusion Criteria:Healthy males or females aged 18 to 65 at the time of informed consentBody weight between 40-100Kg and body mass index between 16-35 kg/m2Forced expiratory volume (FEV1) >85% of predicted value for age, sex, and heightSurgically sterile or using an acceptable contraceptive method from the time of signing the informed consent form until at least 30 days after the last dose of Study Drug.Key Exclusion Criteria:History of illness or condition that might pose an additional risk or may confound study results.Pregnant or lactating (breast feeding)History of severe allergic reaction to a liposomal productClinically significant abnormalities in Screening laboratory resultsKnown history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis BTreatment with another investigational drug, biological agent, or device within 30 days of screening, or 5 half-lives of investigational drug, whichever is longerDrug or alcohol abuse within the past yearHistory of moderate to heavy smoking or vaping (>10 cigarettes/sessions per day) within 6 months prior to the dose of study drug.
Participants must be willing to refrain from smoking or vaping within 1 week of dosing through Day 15Systemic or inhaled corticosteroids within 3 months prior to screening.Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study
Source: ClinicalTrials.gov (NCT05712538). StuddyBuddy aggregates publicly available trial information.