Category: Clinical Study
Shots: The P-I clinical study evaluates the safety, PK, and PD of single & multiple ascending doses of DNL343 in 95 healthy volunteers with ALS & other P-I studies assess SAR443820 for the same indication The results showed that DNL343 was generally well tolerated for ~14 days of dosing, dose-related increases in CNS distribution & PK profile […]
Shots: The companies reported the preclinical results of MRT5500 demonstrating the potential of the vaccine in neutralizing the Abs against SARS-CoV-2. The two doses of MRT5500 induced neutralizing antibody levels significantly higher than those observed in COVID-19 patients The preclinical data support the advancement of MRT5500 for clinical development. The companies anticipate the initiation of […]
Shots: The P-I/II study of AZD1222 has resumed in Japan following the discussion with the PMDA. Additionally, the company is in talks with the US FDA to facilitate review of the information needed to decide regarding the resumption of the US trial A standard review process triggered a voluntary pause to vaccination across all global […]
Shots: Zydus has received the US FDA’s approval to initiate clinical trials of Desidustat in CIA. The company has initiated two P-III studies of desidustat The P-III DREAM-ND (NCT04012957) study is being conducted in 588 CKD patients not-on-dialysis while the P-III DREAM-D is being conducted in 392 CKD patients on dialysis (NCT04215120) The therapy met […]
Shots: The P-III study assessing the efficacy and safety of Favipiravir + SSC vs SCC in 150 mild to moderate patients, randomized within a 48hour window of testing RT-PCR positive for COVID-19 Results: P-III study the improvement in 1EPs with 28.6% faster viral clearance in the overall population as measured by the median time until […]
Shots: Zydus has commenced the adaptive P-I/II human clinical trials of its plasmid DNA vaccine, ZyCoV-D and reported its first human dosing The Adaptive P-I/II dose escalation study will assess the safety, tolerability, and immunogenicity of the vaccine in ~1000 candidates across multiple clinical sites in India. The company has already manufacture clinical GMP batches […]