Name (Synonyms) | Correlation | |
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drug2436 | TY027 Wiki | 1.00 |
drug2787 | convalescent plasma Wiki | 0.50 |
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There is one clinical trial.
The emergence and rapid spread of the coronavirus disease 2019 (COVID-19) since December 2019 across 187 countries globally has become a major public health crisis. COVID-19 was declared a pandemic by the World Health Organisation (WHO) on the 11th March 2020. To date, more than 4,500,000 cases and 300,000 deaths have been reported. COVID-19 is an acute respiratory disease caused by the novel SARS-CoV-2 virus from the Betacoronavirus genus, just like SARS-CoV and MERS-CoV. SARS-CoV-2 is primarily transmitted person-to-person through respiratory droplets or close contact. Fomite transmission has also been implicated as a transmission route. Common respiratory symptoms such as fever, sore throat, cough and shortness of breath, may appear 2 - 14 days after exposure. About 20% of infected cases progress to severe disease resulting in an estimated 2 - 5% mortality reported. With the unrelenting increase in cases being reported worldwide, there is thus an urgent need for therapeutics to be developed and used to disrupt the ongoing pandemic. To date, there is no specific proven antiviral treatment for COVID-19. Supportive care is recommended for symptom relief and for severe cases, organ support is critical for optimal outcome. Numerous vaccine candidates against SARS-CoV-2 are under development and a couple have entered Phase 1 clinical trials. Remdesivir, a nucleotide analog, developed by Gilead Sciences as a treatment for Ebola virus disease is currently being repurposed and undergoing multiple clinical trials to evaluate safety and efficacy in COVID-19 patients. In a preliminary study, convalescent plasma containing neutralizing antibodies against SARS-CoV-2 has also been experimentally administered in critically ill COVID-19 patients with promising results. Donor plasma used was rich in virus specific IgG and IgM antibodies as determined by ELISA. Within days of convalescent plasma treatment, patients showed decrease in viral load (via qRT-PCR), as well as improved clinical status being observed. Tychan's TY027 will be the first biologics in the world, specifically targeting SARS-CoV-2, to enter human clinical trials. It is anticipated that a SARS-COV-2 specific monoclonal antibody therapeutic administered to acutely infected patients could reduce disease severity as well as prevent transmission by reducing viral load and viral shedding. It could also be used as prophylaxis against COVID-19 amongst high risk contacts.
Description: To assess the safety and tolerability of an intravenous (IV) infusion of TY027 when administered to healthy adult volunteers. This will be assessed at various time points by clinical laboratory tests, vital signs and adverse events
Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the maximum concentration (Cmax) of TY027 in human serum.
Measure: Maximum Concentration (Cmax) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the time to maximum concentration (Tmax) of TY027 in human serum
Measure: Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the area under the curve extrapolated to infinity (AUC0-∞) of TY027.
Measure: Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the AUC calculated from time of administration to the last measurable concentration (AUC0-last) of TY027.
Measure: AUC calculated from time of administration to the last measurable concentration (AUC0-last) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the half-life (t1/2) of TY027 in human serum.
Measure: Half-Life (t1/2) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate the volume of distribution (Vd) of TY027 in human serum.
Measure: Volume of Distribution (Vd) - Pharmacokinetic Assessment Time: 84 DaysDescription: Constant monitoring of the levels of antibody in subject sera through various time points as stated below would help elucidate clearance [CL] of TY027 in human serum.
Measure: Clearance [CL] - Pharmacokinetic Assessment Time: 84 Days