NCT05712538CompletedPhase 1
Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects and Adults With Cystic Fibrosis.
A Study in Two Parts: (Phase 1) A Randomized, Double-blinded, Placebo--controlled, Single-ascending-dose Study in Healthy Adult Subjects and (Phase 1b) an Open-label, Nested, Divided-dose Study in Adults With Cystic Fibrosis to Assess the Safety, Tolerability, and Pharmacokinetics of ARCT-032
Source: ClinicalTrials.gov · Last updated 13 Nov 2024
Brief summary (registry, in English)
Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-032 in healthy adult subjects (Phase 1) and of two doses in Adults with Cystic Fibrosis (Phase 1b).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 39 (actual)
- First submitted
- 26 Jan 2023
- Start date
- 15 Feb 2023
- Primary completion date
- 29 Jul 2024
- Lead sponsor
- Arcturus Therapeutics, Inc.
- Diseases
- Cystic fibrosis
- NCT number
- NCT05712538
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 39
- From 15 Feb 2023 to the primary completion date, 29 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with another investigational drug, biological agent, or device within 30 days of screening, or 5 half-lives of investigational drug, whichever is longer
- Drug or alcohol abuse within the past year
- History 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 15
- Systemic or inhaled corticosteroids within 3 months prior to screening (Phase 1 only).
Other illness
- History of illness or condition that might pose an additional risk or may confound study results.
- History of severe allergic reaction to a liposomal product
- Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
- 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
Lab values
- Clinically significant abnormalities in Screening laboratory results
Other
- Pregnant or lactating (breast feeding)
Who the study is looking for
- Phase 1: Healthy males or females aged 18 to 65 years at the time of informed consent.
- Phase 1b: Males or females aged 18 to 65 years with confirmed diagnosis of CF documented in subject's medical record
- Body weight between 40-100Kg and body mass index between 16-35 kg/m2
- Phase 1: Forced expiratory volume (FEV1) at screening \>85% of predicted value for age, sex, and height.
- Phase 1b: FEV1 at screening between 50% and 100% of predicted value
- Surgically 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.
- Phase 1b only: Subjects with CF on CFTR modulator therapy must be on a stable regimen for at least 2 months prior to screening.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| New Zealand Clinical Research Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.