Tags : P-I

Bio-Thera Initiates P-I Study of BAT2206 Proposed Biosimilar to Stelara

Shots: The first patient has been dosed in a P-I clinical study to compare the PK and safety of BAT2206, a proposed biosimilar to Stelara (ustekinumab) to US/EU-sourced reference product in healthy volunteers The company is expected to enroll 270 healthy volunteers. BAT2206 represents the fifth biosimilar of Bio-Thera’s portfolio that has advanced into clinical […]Read More

Celltrion Initiates P-I Study of CT-P59 Against COVID-19 in Korea

Shots: The Korean MFDS has approved Celltrion’s IND to initiate a P-I trial of CT-P59 in patients with COVID-19. The company has initiated the enrollment and is set to evaluate the safety, tolerability, efficacy, PK, and immunogenicity of CT-P59 and anticipates the completion of study in Q3’20 The company anticipates the results of P-II & […]Read More

AstraZeneca Initiates P-I Study of AZD7442 Against COVID-19

Shots: The first participants have been dosed in a P-I trial of AZD7442 to assess safety, tolerability, and PK of the combination mAbs in up to 48 healthy participants aged 18-55 yrs. in the UK. The study is funded by DARPA If AZD7442 proves to be tolerated and has a favorable safety profile in the […]Read More

Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in

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 […]Read More

Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced/

Shots: Oncorus has initiated a P-I study assessing ONCR-177 as monothx. and in combination with Merck’s Keytruda in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors The P-I study enrolls ~21 cancer patients while P-II study enrolls patients to histology- specific expansion cohorts. The P-I study will evaluate the safety and […]Read More

GSK and Medicago to Initiate P-I Trial of Plant-Based COVID-19

Shots: The two companies collaborated to develop a COVID-19 vaccine combining Medicago’s recombinant Coronavirus Virus-Like Particles (CoVLP) with GSK’s pandemic adjuvant system. The partners are planning to initiate P-I study in mid-July followed by pre-clinical results that showed combining the two platforms demonstrated a high level of neutralizing Abs following a single dose The study […]Read More

Eli Lilly to Initiate P-I Study of its Second Antibody

Shots: Lilly’s partner Junshi has dosed the first healthy volunteer in a study evaluating JS016 to combat COVID-19. The study is being conducted by Junshi in China while Lilly to imminently initiate its P-I study in the US Both P-I studies aim to evaluate the safety, tolerability, PK and immunogenicity of JS016 in healthy participants […]Read More

Sinovac Initiates the P-I Clinical Study for Vaccine Candidate Against

Shots The company has commenced P-I clinical study assessing its vaccine candidate vs PBO in 144 healthy adults, aged 18-59yrs, with two different dosages of the vaccine candidate, conducted in Jiangsu Province The study evaluates the safety, tolerance, and preliminary immunogenicity of Sinovac’s SARS-CoV-2 vaccine under which two-thirds of the volunteers will be vaccinated with […]Read More