Status:
COMPLETED
Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects
Lead Sponsor:
Arcturus Therapeutics, Inc.
Conditions:
SARS-CoV-2
Eligibility:
All Genders
21-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Determine safety and tolerability and immungenicity of investigational vaccine ARCT-021 in healthy adult volunteers.
Detailed Description
Randomized, double blinded (study site staff, subjects and Sponsor), placebo controlled, adaptive, ascending dose study evaluating administration of ARCT-021 in healthy adult subjects. 0.9% sterile sa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2021
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04480957
Start Date
August 4 2020
End Date
January 29 2021
Last Update
August 18 2021
Active Locations (1)
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1
SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital
Singapore, Singapore, 169608