Safety, Tolerability and Pharmacokinetics of ARCT-810 in Healthy Adult Subjects
NCT ID: NCT04416126
Last Updated: 2023-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2020-06-01
2020-12-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ARCT-810
Ascending single doses of ARCT-810 administered intravenously
ARCT-810
ARCT-810 is an investigational medicinal product comprising OTC mRNA formulated in a lipid nanoparticle (LNP) under development.
Placebo
Single doses of 0.9% Saline administered intravenously
Placebo
The placebo for this study is 0.9% sterile saline.
Interventions
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ARCT-810
ARCT-810 is an investigational medicinal product comprising OTC mRNA formulated in a lipid nanoparticle (LNP) under development.
Placebo
The placebo for this study is 0.9% sterile saline.
Eligibility Criteria
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Inclusion Criteria
2. Body weight ≤ 100Kg and body mass index \<35 kg/m2
3. 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.
4. Willing and able to comply with protocol-defined procedures and complete all study visits
5. 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
Exclusion Criteria
2. 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
3. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed within 7 days prior to Study Day 1
4. Known history of or positive test for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B
5. Uncontrolled hypertension (BP \> 160/100 mm Hg)
6. Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational drug, whichever is longer
7. Recent (within 1 year) history of, or current drug or alcohol abuse
8. 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
18 Years
65 Years
ALL
Yes
Sponsors
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Arcturus Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christian Schwabe, MD
Role: PRINCIPAL_INVESTIGATOR
Auckland Clinical Studies (ACS) Ltd.
Locations
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Auckland Clinical Studies (ACS) Ltd.
Auckland, , New Zealand
Countries
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Other Identifiers
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ARCT- 810-01
Identifier Type: -
Identifier Source: org_study_id
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