Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021
NCT ID: NCT04728347
Last Updated: 2024-12-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE2
65 participants
INTERVENTIONAL
2021-01-04
2021-12-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ARCT-021
Participants will receive a single dose of ARCT-021 on Day 1
ARCT-021
ARCT-021 single dose
Long-term follow up from ARCT-021-01
Participants will not receive intervention but will be followed for safety.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ARCT-021
ARCT-021 single dose
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. are able to give consent
2. must have completed Study ARCT-021-01
3. agree to comply with all study visits and procedures
Only for subjects that will receive ARCT-021 in this study:
4. are healthy and medically stable
5. are not planning to donate blood or plasma until 28 days after the last dose of ARCT-021.
6. are willing to refrain from strenuous exercise/activity and alcohol for at least 72 hours prior to study visits and until 28 days after the last dose of ARCT-021.
7. are willing to adhere to contraception requirements if sexually active and/or are of child-bearing potential
Exclusion Criteria
1. are unable to comply with the study visits or procedures in Study ARCT-021-01
2. received placebo in the Parent Study and who are not willing to receive ARCT-021 in this study.
Only for subjects that will receive ARCT-021 in this study:
3. have or will receive any of the SARS CoV-2 or another experimental coronavirus during this study.
4. have a diagnosis of new clinically significant abnormalities including but not limited to
* Respiratory disease requiring daily medications or oxygen currently or any treatment of respiratory disease exacerbations
* Significant heart conditions
* Significant neurological conditions
* Significant blood disorders
* Newly diagnosed autoimmune disease
* Major surgery
5. have abnormal screening laboratory results
6. have uncontrolled diabetes
7. use of any prescription or over-the-counter medications within 7 days prior to vaccination
8. have received immunoglobulins and/or any blood or blood products
9. have a bleeding disorder
10. have uncontrolled blood pressure
11. have been treated with another investigational drug, biological agent, or device since completion of the Parent Study
12. have received or plan to receive:
* A licensed, live vaccine within 4 weeks before or after study vaccination, or
* A licensed, inactivated vaccine within 2 weeks before or after study vaccination
13. have traveled outside of Singapore within 30 days before the vaccination or plans to travel outside of Singapore within 60 days after vaccination.
14. other restrictions may apply
21 Years
80 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Arcturus Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital
Singapore, , Singapore
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ARCT-021-02
Identifier Type: -
Identifier Source: org_study_id