Pharmaceutical company Jemincare group said on Tuesday that it has completed its phase I clinical trial of self-developed novel coronavirus specific of its anti-SARS-CoV-2 neutralizing antibody, JMB2002.
The company carried out a single-centre, randomized, double-blind, placebo-controlled, single-dose escalation phase I trial to evaluate JMB2002's tolerability, safety, pharmacokinetic characteristics and immunogenicity in healthy subjects.
About 40 subjects were enrolled in the company's four dose groups from low to high. The results have shown that only one subject underwent grade two adverse events (TEAE) related to the study drug. The other TEAEs were all in grade one and all TEAEs were in remission or completely recovered. None of the subjects had any serious adverse events (SAE) related to the study drug.
Following the encouraging results of phase 1 clinical study, the company plans further exploration of JMB2002's clinical efficacy study in patients with COVID-19 virus infection to contribute to the treatment of COVID-19 in the world.
As early as the outbreak of the COVID-19 pandemic, the company said its R&D team has efficiently isolated the neutralizing antibody JMB2002 targeting SARS-CoV-2 RBD from a naïve human antibody library containing over 1010 clones.
TiumBio files Clinical Trial Application to start Phase 1b TU7710 study
Moderna reports positive interim results from next-generation COVID-19 vaccine trial
Scancell initiates SCOPE trial's iSCIB1+ cohort
Valneva launches Phase 1 trial for next-generation Zika vaccine
argenx obtains VYVGART approval for primary immune thrombocytopenia in Japan
Bio-Thera Solutions' BAT8006 phase II Study receives US FDA IND approval