Tags : Clinical Study

Zydus to Initiate Clinical Study of Desidustat in Patients with

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 […]Read More

Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against

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 […]Read More

Regeneron Initiates its First Clinical Study of Antibody Cocktail for

Shots: The company has reported the initiation of the first clinical trial of REGN-COV2. The REGN-COV2 clinical program will consist of four separate study populations: hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people that are at high risk of exposure and uninfected people with close exposure to a COVID-19 patient The first two adaptive […]Read More

Johnson & Johnson to Initiate P-I/IIa Clinical Study of its

Shots: Janssen has accelerated the initiation of the P-I/IIa study of its investigational Ad26.COV2-S recombinant vaccine. Earlier, the company had scheduled the clinical trial to begin in Sept’2020, the trial is now expected to commence in the second half of July The P-I/IIa study will evaluate the safety, reactogenicity & immunogenicity Ad26.COV2-S, recombinant in 1045 […]Read More

Eli Lilly Initiates the World’s First Clinical Study to Evaluate

Shots: Eli Lilly reported that first patients have been dosed in a P-I study of LY-CoV555, the first Ab emerge from the collaboration b/w Lilly & AbCellera to create Ab therapies against COVID-19. The P-I J2W-MC-PYAA study aims to evaluate the safety, tolerability, PK/PD of LY-CoV555 following a single dose administered to participants hospitalized for […]Read More

Atriva to Initiate P-II Clinical Study Evaluating ATR-002 for Treatment

Shots: Atriva will commence P-II study assessing ATR-002 vs PBO in hospitalized patients with moderate COVID-19, expected to be initiated in July’2020 ATR-002’s MOA inhibits SARS-CoV-2 viral propagation and prevents the cytokine storm as demonstrated in its preclinical studies. The dual antiviral and immunomodulatory effect allows the therapy to prevent progression to critical-stage COVID-19 in […]Read More

Novavax Initiates P-I/II Study of NVX‑CoV2373 Vaccine Against COVID-19

Shots: The company reported the enrollment of the first participants in a P-I/II clinical study of its vaccine candidate, NVX‑CoV2373, developed utilizing nanoparticle technology. The vaccine includes Novavax’ Matrix‑M adjuvant to enhance immune responses and stimulate high levels of neutralizing Abs with its expected preliminary immunogenicity and safety results in Jul’2020 The P-I-part evaluates the […]Read More

CoVIg-19 Plasma Alliance to Initiate Clinical Study Evaluating Hyperimmune Therapy

Shots: Shots: Takeda, CSL and NIH’s, CoVIg-19 Plasma Alliance has expanded membership and CT collaborations with >10 plasma and non-plasma companies globally to develop a plasma-derived hyperimmune globulin therapy against COVID-19 The news member to the program includes ADMA Biologics, BioPharma Plasma, GC Pharma, and Sanquin. All the organization will provide specialist advisory expertise, technical […]Read More