144
Participants
Start Date
May 9, 2024
Primary Completion Date
April 30, 2026
Study Completion Date
June 30, 2026
SIBP-A13 formulation for injection
"SIBP-A13: injection; strength: 1, 2, 4, 5, 6 or 8 mg; dose escalation and the first group is 1mg (intravenous infusion). Starting from the lowest dose, when the former does not meet the termination criteria, then start the next dose group study until Maximum Tolerated Dose (MTD). The study adopts a 3+3 dose increasing design. Administration period: divided into single administration and multiple administration. Single dose administration: The participants are administered a single dose on the first day for a total of 21 days of observation, and complete the examinations and evaluations specify in the protocol. If dose-limiting toxicity (DLT) does not occur, the participant enters a multiple dosing period. Multiple administration: administration every 3 weeks."
RECRUITING
Shanghai Pulmonary Hospital, Shanghai
Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Shanghai Institute Of Biological Products
INDUSTRY