A Single Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of RBD1016

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

February 5, 2021

Primary Completion Date

September 8, 2021

Study Completion Date

November 2, 2021

Conditions
Healthy Volunteers
Interventions
DRUG

RBD1016

"Sentinel cohort design is used in each cohort: each cohort will be administered in two batches, the first 2 subjects will receive RBD1016 or placebo respectively, and safety assessment will be done on D8±1. After safety is confirmed through SRC assessment, the remaining 6 subjects will be randomly assigned to receive RBD1016 or placebo in a ratio of 5:1. SRC will assess the safety after all the subjects in each cohort complete the 28-day safety observation and the subjects may proceed to the next dose cohort with permission.~Only after all the subjects in the previous dose cohort have completed the safety assessment by SRC (observed for 28 days) may the next dose cohort be initiated with permission."

DRUG

Placebo

the same as RBD1016

Trial Locations (1)

Unknown

Scientia Clinical Research Ltd, Randwick

All Listed Sponsors
lead

Suzhou Ribo Life Science Co. Ltd.

INDUSTRY

NCT04685564 - A Single Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of RBD1016 | Biotech Hunter | Biotech Hunter