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SARS-CoV-2Phase 1/2NCT04480957

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

A Phase 1/2 study testing ARCT-021 Dose 1, ARCT-021 Dose 2 and ARCT-021 Dose 3 in people with SARS-CoV-2, run by Arcturus Therapeutics, Inc. at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Determine safety and tolerability and immungenicity of investigational vaccine ARCT-021 in healthy adult volunteers. Read more about this study

Who is it for?
Ages 21 to 80 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2
What is being tested?
ARCT-021 Dose 1, ARCT-021 Dose 2 and ARCT-021 Dose 3
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
106 participants
Where
1 siteSingapore
Study dates
4 Aug 2020to 29 Jan 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • SingHealth Investigational Medicine Unit (IMU), Singapore General Hospital

    Singapore, 169608

Other trials in Singapore

About this study

Official title: 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

Determine safety and tolerability and immungenicity of investigational vaccine ARCT-021 in healthy adult volunteers.

Read the 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.

Conditions
SARS-CoV-2
Being tested
ARCT-021 Dose 1, ARCT-021 Dose 2, ARCT-021 Dose 3, ARCT-021 Dose 4, ARCT-021 Dose Regimen 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARCT-021 Dose 1Biological

    ARCT-021 Dose 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP)

  • ARCT-021 Dose 2Biological

    ARCT-021 Dose 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021

  • ARCT-021 Dose 3Biological

    ARCT-021 Dose 3 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021

  • ARCT-021 Dose 4Biological

    ARCT-021 Dose 4 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021

  • ARCT-021 Dose Regimen 1Biological

    ARCT-021 dose regimen 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021

  • ARCT-021 Dose Regimen 2Biological

    ARCT-021 dose regimen 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021

  • PlaceboOther

    Sterile 0.9% saline

Study groups in NCT04480957
Study groupRoleWhat they receive
Escalation Cohort dose 1 of ARCT-021, 21 - 55 yearsExperimentalEscalation Cohort dose 1 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
Receives: Biological: ARCT-021 Dose 1; Other: Placebo
Escalation Cohort dose 2 of ARCT-021, 21 -55 yearsExperimentalEscalation Cohort dose 2 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
Receives: Biological: ARCT-021 Dose 2; Other: Placebo
Escalation Cohort dose 3 of ARCT-021, 21 - 55 yearsExperimentalEscalation Cohort dose 3 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
Receives: Biological: ARCT-021 Dose 3; Other: Placebo
Escalation Cohort dose 4 of ARCT-021, 21 - 55 yearsExperimentalEscalation Cohort dose 4 of ARCT-021 administered through 0.5 mL intramuscular injection in the deltoid muscle.
Receives: Biological: ARCT-021 Dose 4; Other: Placebo
Expansion cohort dose regimen 1, 21 - 55 years.ExperimentalExpansion cohort dose regimen 1, administered through 0.5 mL intramuscular injection in the deltoid muscle.
Receives: Biological: ARCT-021 Dose Regimen 1; Other: Placebo
Expansion cohort dose regimen 2, 21 - 55 years.ExperimentalExpansion cohort dose regimen 2, administered through 0.5 mL intramuscular injection in the deltoid muscle.
Receives: Biological: ARCT-021 Dose Regimen 2; Other: Placebo
Expansion cohort dose regimen 1, 56 - 80 yearsExperimentalExpansion cohort dose regimen 1, administered through 0.5 mL intramuscular injection in the deltoid muscle.
Receives: Biological: ARCT-021 Dose Regimen 1; Other: Placebo
Expansion cohort dose regimen 2, 56 - 80 yearsExperimentalExpansion cohort dose regimen 2, administered through 0.5 mL intramuscular injection in the deltoid muscle.
Receives: Biological: ARCT-021 Dose Regimen 2; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence, severity and dose-relationship of AEs

    Safety and tolerability of ARCT-021 assessed by determining the incidence, severity and dose-relationship of AEs by dose

    Measured: 56 days

Secondary outcomes (3)

  1. Geometric mean titre for SARS-CoV-2-specific serum neutralizing antibody

    SARS-CoV-2-specific serum neutralizing antibody levels, expressed as GMT

    Measured: Up to 56 days

  2. Mean titre for SARS-CoV-2-specific serum neutralizing antibody levels

    SARS-CoV-2-specific serum neutralizing antibody levels, expressed as mean titer

    Measured: Up to 56 days

  3. Geometric mean fold rise in titre for SARS-CoV-2-spike protein specific neutralizing antibody levels

    GMFR in titre for SARS-CoV-2-spike protein specific neutralizing antibodies from before vaccination to each subsequent time point

    Measured: Up to 56 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2020
  2. Study start4 Aug 2020
  3. Primary completion29 Jan 2021
  4. Study completion29 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04480957
Sponsor's protocol ID
ARCT-021-01
Status last verified
Aug 2021
First submitted
17 Jul 2020
Last updated
18 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ARCT-021 Dose 1, ARCT-021 Dose 2 and ARCT-021 Dose 3 in people with SARS-CoV-2, run by Arcturus Therapeutics, Inc. at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, severity and dose-relationship of AEs (time frame: 56 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04480957.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.

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