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
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.

Completed
SARS-CoV-2

Biological: ARCT-021 Dose 1

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)

Biological: ARCT-021 Dose 2

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

Biological: ARCT-021 Dose 3

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

Biological: ARCT-021 Dose 4

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

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 full length 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 full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021

Other: Placebo

Sterile 0.9% saline

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 21 Years ~ Maximum: 80 Years
Countries
Singapore
Locations

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

Jenny Low Guek Hong, MD, Principal Investigator
SingHealth Investigational Medicine Unit (IMU)

Arcturus Therapeutics, Inc.
NCT Number