COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04480957

Jenny Low Guek Hong, MD

Steve Hughes, steveh@arcturusrx.com (PI email not reported)

2020-07-22

Completed

RCT

Randomized

Adaptive

Blind label

single-center

Prevention

inclusion criteria: healthy males or females aged 21 to 80 at the time of informed consent. body mass index 18-35 kg/m2, inclusive, at screening 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 temperature is less than 99.3 degrees fahrenheit (37.4 degrees celsius) at screening and at the pre-dose evaluation on day 1 willing and able to comply with protocol-defined procedures and complete all study visits males must be surgically sterile or willing to use adequate contraception; females must be post-menopausal, surgically sterile or willing to use adequate contraception

pregnant or breast feeding clinically significant abnormalities in medical history out of range screening laboratory results known history of or positive test for human immunodeficiency virus (hiv), hepatitis c or chronic hepatitis b uncontrolled hypertension (bp > 160/100 mm hg) uncontrolled diabetes any history of autoimmune disease immunodeficiency of any cause history of chronic liver disease 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 has any blood dyscrasias or significant disorder of coagulation has an acute illness, as determined by the investigator, with or without fever [temperature >38.0 degrees celsius (100.4 degrees fahrenheit)] within 72 hours prior to each vaccination malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated. received or plans to receive another vaccine within 4 weeks before study vaccination or at any time during the study. receipt of any other sars cov-2 or other experimental coronavirus vaccine at any time prior to study or planned during the study 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

7

Arcturus Therapeutics, Inc.

21

80

Singapore

Healthy volunteers

N/A

106

Incidence, severity and dose-relationship of AEs

None

Phase 1/Phase 2

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