Safety, Tolerability, and Pharmacokinetics of ARCT-032 in Healthy Adult Subjects

• Status: Not yet recruiting
• Trial end date: 2024-03-30
• Target enrollment: 0
• Participant gender: All

Summary

Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-032 in healthy adult subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Arcturus Therapeutics, Inc.
• Collaborator: Novotech CRO

Criteria

Key Inclusion Criteria:

1. Healthy males or females aged 18 to 65 at the time of informed consent

2. Body weight between 40-100Kg and body mass index between 16-35 kg/m2

3. Forced expiratory volume (FEV1) >85% of predicted value for age, sex, and height

4. 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.

Key Exclusion Criteria:

1. History of illness or condition that might pose an additional risk or may confound study results.

2. Pregnant or lacating (breast feeding)

3. History of severe allergic reaction to a liposomal product

4. Clinically significant abnormalities in Screening laboratory results

5. Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B

6. Treatment with another investigational drug, biological agent, or device within 30 days of screening, or 5 half-lives of investigational drug, whichever is longer

7. Drug or alcohol abuse within the past year

8. 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

9. Systemic or inhaled corticosteroids within 3 months prior to screening.

10. 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