In this first-in-humans dose escalation study, SA55 will be evaluated for safety, tolerability, and pharmacokinetics. The study is intended to enable future studies of SA55-injection's efficacy in preventing and treating COVID-19.
This is a Phase I, first time in human, randomised, double-blind, placebo-controlled, and dose escalation study. A Screening Period of up to 14 days (Day -14 through Day 0); A Treatment Period during which participants will be resident at the hospital from Day 0, 1 day before IMP administration (on Day 1) . A Follow up Period lasting 183 days after the IMP dose. The study will be conducted at a single study centre in Beijing, China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Novel coronavirus broad-spectrum neutralizing antibody SA55 injection
Placebo for Novel coronavirus broad-spectrum neutralizing antibody SA55 injection
Beijing Ditan Hospital Capital Medical University
Beijing, China
RECRUITINGIncidence of participants with adverse events (AEs) and serious AEs in healthy individuals
The incidence of adverse events (including clinical symptoms and vital signs abnormalities, laboratory examination abnormalities, 12 lead electrocardiogram abnormalities, etc.) and serious adverse events;
Time frame: 6 months
Time to reach maximum concentration (Tmax)
Tmax will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Time frame: 6 months
Observed maximum concentration (Cmax)
Cmax will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Time frame: 6 months
Elimination half life (t½)
t½ will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Time frame: 6 months
Systemic clearance (CL)
CL will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Time frame: 6 months
Volume of distribution (Vd)
Vd will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Time frame: 6 months
AUCinf
AUCinf will be assessed after administration of SA55 (IM injection) using noncompartmental methods.
Time frame: 6 moths
Anti drug antibody levels (ADA)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
To evaluate the serum neutralizing activity of SA55 injection at different time points after administration in healthy individuals. It means anti drug antibody levels (ADA) in serum at different time points
Time frame: 6 months