Shots:
- The P-I study follows positive pre-clinical results and the Korean MFDS’ IND approval. The study will enroll ~32 healthy volunteers in collaboration with Chungnam National University Hospital to assess the safety of the antiviral Ab treatment candidate in patients who have not been diagnosed with COVID-19
- The trial is expected to be completed in Q3’2020. The company plans to conduct a P-I trial of the therapy in mild COVID-19 patients across the EU, including the UK, followed by global P-II/III trials in patients with mild/moderate COVID-19. Celltrion expects preliminary results from pivotal studies by late 2020
- Additionally, the company will evaluate the treatment for use as a preventative measure and enroll people in close contact with COVID-19 patients globally with its anticipated results in Q1’21. Celltrion’s Ab treatment candidate has demonstrated effectiveness in neutralizing the mutated G-variant strain of SARS-CoV-2 (D614G variant)
Click here to read full press release/ article | Ref: Businesswire | Image: GMP News
