Status and phase
Conditions
Treatments
About
This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose Phase I trial.
Full description
This study includes screening (Days -16 to -3), check-in (Day -2), enrollment (Day -1), dosing (Day 1), observational period (Days 2 to 3), discharge day (Day 4), and safety follow-up visit (Day 8). Forty eligible subjects will be enrolled into 4 dose cohorts (10 for each cohort), and every 10 subjects will be randomized in a 4:1 ratio to receive a single dose of either SHR4640 (n=8) or placebo (n=2).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Received the last dose of a study drug (or treatment with a medical device) within 30 days or 5 T1/2 (whichever is longer) of the study drug of Day 1 or are currently participating in another study of a study drug (or medical device).
Any other medical or psychological condition, which in the opinion of the Investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or to complete the study.
Primary purpose
Allocation
Interventional model
Masking
40 participants in 5 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal