40
Participants
Start Date
September 6, 2021
Primary Completion Date
March 2, 2023
Study Completion Date
March 9, 2023
LQ036
"For Each part of the study, a staggered dosing schedule may be used for the first dose level, in each cohort including 2 sentinel subjects (1 active and 1 placebo) initiating dosing first and the remaining 6 subjects for Part A-C and 8 subjects for Part D initiating dosing no sooner than the next day. Each study part (A, B, C, and D) will be completed sequentially, but with partial overlapping. Part B and C may only be initiated after review of the safety, tolerability, and PK data following dosing of the SAD Cohort 3 or 4.~Part D may be initiated when safety tolerability and PK data are known and deemed acceptable by the SRC for multiple doses in Part B, at least at the same concentration to be administered in Part D."
Matching Placebo
Matching Placebo for LQ036: Matching Placebo
Nucleus Network Melbourne, Melbourne
Q-Pharm Pty Ltd (Nucleus Network Brisbane), Brisbane
Lead Sponsor
Shanghai Novamab Biopharmaceuticals Co. Ltd.
UNKNOWN
Syneos Health
OTHER