Tags : Dosing

J&J Pauses Dosing in COVID-19 Vaccine Studies Due to Unexplained

Shots: J&J temporarily pauses the further dosing in all clinical studies of its COVID-19 vaccine candidate JNJ-78436735, including the P-III ENSEMBLE trial, due to an “unexplained illness” in one participant Following the guidelines, the subject’s illness is being reviewed and evaluated by the ENSEMBLE independent DSMB, as well as its own internal clinical and safety […]Read More

PhaseBio Reports First Patients Dosing in its P-III REVERSE-IT Study

Shots: The company has reported the expansion of its P-III REVERSE-IT study for bentracimab in Canada where the first patients from major health centers globally have been enrolled (approx. 200 patients) and dosed Bentracimab demonstrated sustained reversal of the antiplatelet activity of Brilinta (ticagrelor). In a translational study, bentracimab achieved equivalent reversal of branded ticagrelor […]Read More

Theravance Reports First Patient Dosing in a P-II Study of

Shots: The first patient has been dosed in a P-II study of TD-0903. The P-II study consists of two parts: the first part will assess the safety, tolerability, and clinical response to treatment in sequential ascending dose cohorts of hospitalized COVID-19 patients, with each patient demonstrating hypoxia being dosed for 7 days The second part […]Read More

Eli Lilly Reports Dosing of its First Patient with Tirzepatide

Shots: The P-III SURPASS-CVOT study involves assessing non-inferiority and superiority of tirzepatide vs Trulicity (dulaglutide, 15mg) in 12,500 patients with T2D and atherosclerotic cardiovascular disease from 30 countries. The company expects for the completion of trial in four years The 1EPs will measure time to first occurrence of MACE-3, the composite endpoint of CV death, […]Read More

JHL Biotech Reports Dosing of its First Patient with JHL1266

Shots: The study involves assessing of JHL1266 vs Prolia sourced from the EU and the US in healthy human subjects evaluating its PK, PD, and immunogenicity The JHL1266 is proved to be a milestone and an initiative in bringing safe, effective, and high-quality biologics JHL1266 is a mAb targeting RANKL works by inhibition of developed […]Read More

BioNTech and Pfizer Complete Dosing of BNT162 in First Cohort

Shots: The companies reported that the first cohort of BioNTech’s P-I/II clinical trial has dosed 12 participants with BNT162 in Germany since dosing began on Apr 23, 2020. Following the regulatory approvals, both the companies plan to initiate the clinical study for BNT162 in the US The dose-escalation portion of the P-I/II study will include […]Read More

Theravance Reports First Patient Dosing in P-I Study with TD-0903

Shots: :Stosohth:ththShots: The company reported the dosing of a first healthy volunteer in a P-I study of TD-0903 and anticipates that TD-0903 has the potential to inhibit the cytokine storm associated with ALI and prevent progression to ARDS Earlier, Theravance has received approval to initiate the P-I study for assessing safety, tolerability and pharmacokinetics of […]Read More

I-Mab Reports Dosing of TJ202/MOR202 in P-II Trial for Patients

Shots: The first P-II NCT03860038 trial involves assessing of TJ202/MOR202 as a 3L treatment in patients with R/R MM while the second P-II trial assess TJ202/MOR202 + lenalidomide (LEN) + dexamethasone (DEX) vs LEN + DEX in 1L R/R MM In 2017, I-Mab in-licensed TJ202/MOR202 from MorphoSys while holds exclusive rights to develop and commercialize […]Read More