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Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT04480957
Recruitment Status : Recruiting
First Posted : July 22, 2020
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Arcturus Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE July 17, 2020
First Posted Date  ICMJE July 22, 2020
Last Update Posted Date August 17, 2020
Actual Study Start Date  ICMJE August 4, 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2020)
Incidence, severity and dose-relationship of AEs [ Time Frame: 56 days ]
Safety and tolerability of ARCT-021 assessed by determining the incidence, severity and dose-relationship of AEs by dose
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2020)
  • Geometric mean titre for SARS-CoV-2-specific serum neutralizing antibody [ Time Frame: Up to 56 days ]
    SARS-CoV-2-specific serum neutralizing antibody levels, expressed as GMT
  • Mean titre for SARS-CoV-2-specific serum neutralizing antibody levels [ Time Frame: Up to 56 days ]
    SARS-CoV-2-specific serum neutralizing antibody levels, expressed as mean titer
  • Geometric mean fold rise in titre for SARS-CoV-2-spike protein specific neutralizing antibody levels [ Time Frame: Up to 56 days ]
    GMFR in titre for SARS-CoV-2-spike protein specific neutralizing antibodies from before vaccination to each subsequent time point
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 17, 2020)
  • Increase in SARS-CoV-2--spike protein-specific binding antibody levels [ Time Frame: Up to 56 days ]
    GMFR in SARS-CoV-2--spike protein-specific binding antibody levels from before vaccination to each subsequent time point
  • Geometric mean SARS-CoV-2--spike protein-specific binding antibody titre [ Time Frame: Up to 56 days ]
    GMT for SARS-CoV-2--spike protein-specific binding antibody levels
  • Mean SARS-CoV-2--spike protein-specific binding antibody titre [ Time Frame: Up to 56 days ]
    Mean titer for SARS-CoV-2--spike protein-specific binding antibody levels
  • SARS-CoV-2-specific serum neutralizing antibody seroconversion rate [ Time Frame: 56 days ]
    Proportion of participants that are seronegative before vaccination achieving a titer of greater than or equal to 20 for SARS-CoV-2-specific serum neutralizing antibodies
  • SARS-CoV-2-specific serum neutralizing antibody seroconversion rate (seropositive baseline) [ Time Frame: 56 days ]
    Proportion of participants that are seropositive before vaccination achieving a greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2-specific serum neutralizing antibody levels
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects
Official Title  ICMJE A Phase 1/2 Randomised, Double Blinded, Placebo Controlled, Ascending Dose Study to Assess the Safety, Tolerability, and Immunogenicity of ARCT-021 in Healthy Adult Subjects
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 saline will serve as a placebo control. Study drug (ARCT-021 or control) will be administered as an intramuscular (IM) injection. The study comprises two parts. In the Phase 1 part escalating dose levels given as a single injection to younger adults (21 to 55 years) will be evaluated sequentially. Two dose levels will be further evaluated in the Phase 2 part of the study in two expansion cohorts in younger adults (21 to 55 years) and in two elderly subject (56 to 80 years) cohorts.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE SARS-CoV-2
Intervention  ICMJE
  • Biological: ARCT-021 Dose 1
    ARCT-021 Dose 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the prefusion spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP)
  • Biological: ARCT-021 Dose 2
    ARCT-021 Dose 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the prefusion spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
  • Biological: ARCT-021 Dose 3
    ARCT-021 Dose 3 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the prefusion spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
  • Biological: ARCT-021 Dose 4
    ARCT-021 Dose 4 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the prefusion spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
  • Biological: ARCT-021 Dose Regimen 1
    ARCT-021 dose regimen 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the prefusion spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
  • Biological: ARCT-021 Dose Regimen 2
    ARCT-021 dose regimen 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the prefusion spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
  • Other: Placebo
    Sterile 0.9% saline
Study Arms  ICMJE
  • Experimental: Escalation Cohort dose 1 of ARCT-021, 21 - 55 years
    Escalation Cohort dose 1 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
    Interventions:
    • Biological: ARCT-021 Dose 1
    • Other: Placebo
  • Experimental: Escalation Cohort dose 2 of ARCT-021, 21 -55 years
    Escalation Cohort dose 2 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
    Interventions:
    • Biological: ARCT-021 Dose 2
    • Other: Placebo
  • Experimental: Escalation Cohort dose 3 of ARCT-021, 21 - 55 years
    Escalation Cohort dose 3 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
    Interventions:
    • Biological: ARCT-021 Dose 3
    • Other: Placebo
  • Experimental: Escalation Cohort dose 4 of ARCT-021, 21 - 55 years
    Escalation Cohort dose 4 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
    Interventions:
    • Biological: ARCT-021 Dose 4
    • Other: Placebo
  • Experimental: Expansion cohort dose regimen 1, 21 - 55 years.
    Expansion cohort dose regimen 1, administered through 0.5 mL intramuscular injection in the deltoid muscle.
    Interventions:
    • Biological: ARCT-021 Dose Regimen 1
    • Other: Placebo
  • Experimental: Expansion cohort dose regimen 2, 21 - 55 years.
    Expansion cohort dose regimen 2, administered through 0.5 mL intramuscular injection in the deltoid muscle.
    Interventions:
    • Biological: ARCT-021 Dose Regimen 2
    • Other: Placebo
  • Experimental: Expansion cohort dose regimen 1, 56 - 80 years
    Expansion cohort dose regimen 1, administered through 0.5 mL intramuscular injection in the deltoid muscle.
    Interventions:
    • Biological: ARCT-021 Dose Regimen 1
    • Other: Placebo
  • Experimental: Expansion cohort dose regimen 2, 56 - 80 years
    Expansion cohort dose regimen 2, administered through 0.5 mL intramuscular injection in the deltoid muscle.
    Interventions:
    • Biological: ARCT-021 Dose Regimen 2
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2020)
92
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2020)
85
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy males or females aged 21 to 80 at the time of informed consent.
  2. Body Mass Index 18-35 kg/m2, inclusive, at screening
  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
  4. Temperature is less than 99.3 degrees Fahrenheit (37.4 degrees Celsius) at screening AND at the pre-dose evaluation on Day 1
  5. Willing and able to comply with protocol-defined procedures and complete all study visits
  6. 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 Criteria:

  1. Pregnant or breast feeding
  2. Clinically significant abnormalities in medical history
  3. Out of range screening laboratory results
  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. Uncontrolled diabetes
  7. Any history of autoimmune disease
  8. Immunodeficiency of any cause
  9. History of Chronic liver disease
  10. Treatment with another investigational drug, biological agent, or device within one month of screening, or 5 half-lives of investigational drug, whichever is longer
  11. Recent (within 1 year) history of, or current drug or alcohol abuse
  12. Has any blood dyscrasias or significant disorder of coagulation
  13. 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
  14. 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.
  15. Received or plans to receive another vaccine within 4 weeks before study vaccination or at any time during the study.
  16. Receipt of any other SARS CoV-2 or other experimental coronavirus vaccine at any time prior to study or planned during the study
  17. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Steve Hughes, MD 858-900-2660 steveh@arcturusrx.com
Contact: Connie Crowley 858-382-1270 Connie@arcturusrx.com
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04480957
Other Study ID Numbers  ICMJE ARCT-021-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arcturus Therapeutics, Inc.
Study Sponsor  ICMJE Arcturus Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jenny Low Guek Hong, MD SingHealth Investigational Medicine Unit (IMU)
PRS Account Arcturus Therapeutics, Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP