First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036

PHASE1TerminatedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 6, 2021

Primary Completion Date

March 2, 2023

Study Completion Date

March 9, 2023

Conditions
Asthma
Interventions
DRUG

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."

OTHER

Matching Placebo

Matching Placebo for LQ036: Matching Placebo

Trial Locations (2)

3004

Nucleus Network Melbourne, Melbourne

4006

Q-Pharm Pty Ltd (Nucleus Network Brisbane), Brisbane

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Shanghai Novamab Biopharmaceuticals Co. Ltd.

UNKNOWN

lead

Syneos Health

OTHER