NCT04728347

Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021

A Phase 2a, Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Arcturus Therapeutics, Inc. · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This is an open-label study enrolling healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will receive either a single injection of ARCT-021 or no injection and be followed for up to 365 days.

Detailed description

This is a phase 2a, open-label study enrolling up to 106 healthy adults that participated in Study ARCT-021-01 (the Parent Study). Participants will enter this study approximately 3 months after their final study visit in the Parent Study. Participants that received placebo in the Parent Study or who are seronegative for SARS-CoV-2 neutralizing antibodies at screening will receive a single dose of ARCT-021 and will be followed for 365 days. Participants that received two injections of ARCT-021 in the Parent Study will not receive any further injections of ARCT-021 and will be followed for 281 days.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	ARCT-021	ARCT-021 single dose

Timeline

• Start date: 2021-01-04
• Primary completion: 2021-12-28
• Completion: 2021-12-28
• First posted: 2021-01-28
• Last updated: 2024-12-30
• Results posted: 2024-12-30

Locations

1 site across 1 country: Singapore

Regulatory

• FDA-regulated drug study