The goal of this clinical trial is to test safety of the investigational product in healthy volunteers. The main questions it aims to answer is when HIB210 is administered as multiple doses, is it: 1. Safe 2. Well tolerated 3. Does the body absorb and eliminate HIB210 as expected
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
HI-Bio Investigational Site
Hialeah, Florida, United States
Number of participants with adverse events
Time frame: Baseline to End of Study (Up to Day 114)
Number of participants with clinical laboratory abnormalities
Time frame: Baseline to End of Study (Up to Day 114)
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Baseline to End of Study (Up to Day 114)
Number of participants with physical examination abnormalities
Time frame: Baseline to End of Study (Up to Day 114)
Number of participants with vital sign abnormalities
Time frame: Baseline to End of Study (Up to Day 114)
PK Parameters: Cmax
Maximum Serum Concentration (Cmax)
Time frame: Baseline to Day 29
PK Parameters: tmax
Time to Maximum Serum Concentration (tmax)
Time frame: Baseline to Day 29
PK Parameters: AUC
Area under the serum concentration-time curve
Time frame: Baseline to Day 29
Anti-drug Antibodies (ADA)
Baseline prevalence and post-dose incidence of ADA
Time frame: Baseline to End of Study (Up to Day 114)
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