This study is a phase 1b clinical trial to investigate the safety and preliminary effects of a single dose of a test drug or placebo to the subjects who has diagnosed as COVID-19 infection.
This study is a phase 1b clinical trial to investigate the safety and preliminary effects of
a single dose of a test drug or placebo to the subjects who has diagnosed as COVID-19
infection.
Study design: prospective, randomized, placebo-controlled, single-blind, single-center
Drug: GX-I7
Recombinant human interleukin-7 hybrid Fc
Other Name: Array
Drug: GX-I7 vehicle
Formulation buffer of recombinant human interleukin-7 hybrid Fc
Key Inclusion Criteria:
1. Subjects who have been confirmed to be COVID-19 corresponding to mild cases of
severity categorization classified by FDA through polymerase chain reaction (PCR) test
or virus gene test (sequencing) and who can be available to be administered within
seven days from the date of manifestation.
2. Subjects who are or will be inpatient.
Key Exclusion Criteria:
1. Patients with symptoms of moderate or higher in the severity classification presented
by FDA have evidence of lower respiratory tract infection in their imaging findings or
need supplemental oxygen therapy or mechanical respiration (ie, non-invasive
ventilation, invasive mechanical ventilation, extracorporeal membrane oxygenation,
etc)
2. Subjects with infectious diseases such as bacteremia or severe pneumonia requiring
active treatment within four weeks prior to the IP administration
Borame Medical Center
Seoul, Korea, Republic of
Minkyu Heo, Study Director
Genexine_Clinical Development Dept.