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ARCT-021 Dose 1Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (5)

Name (Synonyms) Correlation
drug95 ARCT-021 Dose Regimen 2 Wiki 1.00
drug92 ARCT-021 Dose 2 Wiki 1.00
drug93 ARCT-021 Dose 3 Wiki 1.00
drug94 ARCT-021 Dose Regimen 1 Wiki 1.00
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D058186 Acute Kidney Injury NIH 0.23
D014947 Wounds and Injuries NIH 0.19
D016638 Critical Illness NIH 0.13

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0001919 Acute kidney injury HPO 0.23

There is one clinical trial.

Clinical Trials

1 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.

NCT04480957 SARS-CoV-2 Biological: ARCT-021 Dose 1 Biological: ARCT-021 Dose 2 Biological: ARCT-021 Dose 3 Biological: ARCT-021 Dose Regimen 1 Biological: ARCT-021 Dose Regimen 2 Other: Placebo

Primary Outcomes

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

Measure: Incidence, severity and dose-relationship of AEs

Time: 56 days

Secondary Outcomes

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

Measure: Geometric mean titre for SARS-CoV-2-specific serum neutralizing antibody

Time: Up to 56 days

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

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

Time: Up to 56 days

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

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

Time: Up to 56 days

Other Outcomes

Description: GMFR in SARS-CoV-2--spike protein-specific binding antibody levels from before vaccination to each subsequent time point

Measure: Increase in SARS-CoV-2--spike protein-specific binding antibody levels

Time: Up to 56 days

Description: GMT for SARS-CoV-2--spike protein-specific binding antibody levels

Measure: Geometric mean SARS-CoV-2--spike protein-specific binding antibody titre

Time: Up to 56 days

Description: Mean titer for SARS-CoV-2--spike protein-specific binding antibody levels

Measure: Mean SARS-CoV-2--spike protein-specific binding antibody titre

Time: Up to 56 days

Description: 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

Measure: SARS-CoV-2-specific serum neutralizing antibody seroconversion rate

Time: 56 days

Description: 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

Measure: SARS-CoV-2-specific serum neutralizing antibody seroconversion rate (seropositive baseline)

Time: 56 days

No related HPO nodes (Using clinical trials)