CompletedPhase 1

Safety, Tolerability and Pharmacokinetics of ARCT-810 in Healthy Adult Subjects

New Zealand30 participantsStarted 2020-06-01

Plain-language summary

Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-810 in healthy adult subjects.

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Healthy males or females aged 18 to 65 at the time of informed consent.
✓. Body weight ≤ 100Kg and body mass index \<35 kg/m2
✓. Willing to refrain from strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) and alcohol for at least 72 hours prior to study visits and willing to refrain from taking protein supplements for the duration of the study.
✓. Willing and able to comply with protocol-defined procedures and complete all study visits
✓. Males must be surgically sterile or, if engaged in sexual relations with a female of child-bearing potential, the subject must be 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. Females: must be non-pregnant and non-lactating and either: i. surgically sterile or ii. post-menopausal

✕. Clinically significant abnormalities in medical history
✕. Screening laboratory results as follows:
✕. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 7 days prior to Study Day 1
✕. Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
✕. Uncontrolled hypertension (BP \> 160/100 mm Hg)
✕. Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational drug, whichever is longer
✕. Recent (within 1 year) history of, or current drug or alcohol abuse
✕. 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

Incidence, severity and dose-relationship of AEs

Timeframe: 4 weeks

NCT IDNCT04416126

SponsorArcturus Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12-09

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Healthy males or females aged 18 to 65 at the time of informed consent.
✓. Body weight ≤ 100Kg and body mass index \<35 kg/m2
✓. Willing to refrain from strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) and alcohol for at least 72 hours prior to study visits and willing to refrain from taking protein supplements for the duration of the study.
✓. Willing and able to comply with protocol-defined procedures and complete all study visits
✓. Males must be surgically sterile or, if engaged in sexual relations with a female of child-bearing potential, the subject must be 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. Females: must be non-pregnant and non-lactating and either: i. surgically sterile or ii. post-menopausal

✕. Clinically significant abnormalities in medical history
✕. Screening laboratory results as follows:
✕. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 7 days prior to Study Day 1
✕. Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
✕. Uncontrolled hypertension (BP \> 160/100 mm Hg)
✕. Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational drug, whichever is longer
✕. Recent (within 1 year) history of, or current drug or alcohol abuse
✕. 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