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

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Arcturus Therapeutics, Inc.
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Updated on 19 February 2024
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Summary

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

Description

This is a single ascending dose study of ARCT-810 in which approximately 30 subjects are planned to be enrolled. The length of each study participant is approximately 8 weeks from screening to last study visit.

Study participants will be allocated to one of the five different study groups (also called cohorts), to test different doses of ARCT-810. There will be 6 participants in each group. Within each cohort, subjects will be randomized 2:1 to receive ARCT-810 or placebo as an IV infusion.

Details
Condition Ornithine carbamoyltransferase deficiency
Age 18-65 years
Treatment Placebo, ARCT-810
Clinical Study IdentifierNCT04416126
SponsorArcturus Therapeutics, Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
surgically sterile or ii. post-menopausal

Exclusion Criteria

Clinically significant abnormalities in medical history
Screening laboratory results as follows
ALT, AST, GGT, total bilirubin or alkaline phosphatase, > ULN
Random blood glucose and/or HbA1c > ULN
Hemoglobin < LLN
Platelet count < 100x109/L
Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2 calculated by Modification to Diet in Renal Disease [MDRD] study equation
Urine protein:creatinine ratio (UPCR) > 50 mg/mmol
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
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