The primary purpose of this study is to assess the safety and tolerability of single and multiple intravenous (IV) doses of GIGA-2339 in participants with chronic Hepatitis B Virus (HBV) infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Grifols Investigative site
Chandler, Arizona, United States
RECRUITINGSAD and MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: SAD: Up to Day 105; MAD: Up to Day 245
SAD and MAD: Maximum Serum Concentration (Cmax) of GIGA-2339
Time frame: SAD: Pre-dose and at multiple timepoints post-dose up to Day 105; MAD: Pre-dose and at multiple timepoints post-dose up to Day 245
SAD and MAD: Area Under the Concentration Time Curve (AUC) from 0 to the Last Quantifiable Concentration (AUC0-t) of GIGA-2339
Time frame: SAD: Pre-dose and at multiple timepoints post-dose up to Day 105; MAD: Pre-dose and at multiple timepoints post-dose up to Day 245
SAD: AUC From 0 to Infinity (AUC0-∞) of GIGA-2339
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 105
SAD: Dose Normalized Maximum Serum Concentration (DN_Cmax). of GIGA-2339
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 105
SAD: Dose Normalized AUC From 0 to the Last Quantifiable Concentration (DN_AUC0-t) of GIGA-2339
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 105
SAD: Dose Normalized AUC From 0 to Infinity (DN_AUC0-∞) of GIGA-2339
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 105
SAD and MAD: Time to Obtain Maximum Concentration (Tmax) of GIGA-2339
Time frame: SAD: Pre-dose and at multiple timepoints post-dose up to Day 105; MAD: Pre-dose and at multiple timepoints post-dose up to Day 245
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Grifols Investigative site
Huntington Beach, California, United States
RECRUITINGGrifols Investigative site
Lake Forest, California, United States
RECRUITINGGrifols Investigative site
Long Beach, California, United States
RECRUITINGGrifols Investigative site
Oakland, California, United States
SUSPENDEDGrifols Investigative Site
Peachtree Corners, Georgia, United States
RECRUITINGGrifols Investigative Site
Iowa City, Iowa, United States
RECRUITINGGrifols Investigative Site
Lenexa, Kansas, United States
RECRUITINGGrifols Investigative site
Baltimore, Maryland, United States
RECRUITINGGrifols Investigative site
San Antonio, Texas, United States
RECRUITING...and 9 more locations
SAD and MAD: Terminal Half-Life (t1/2) of GIGA-2339
Time frame: SAD: Pre-dose and at multiple timepoints post-dose up to Day 105; MAD: Pre-dose and at multiple timepoints post-dose up to Day 245
SAD and MAD: Volume of Distribution (Vz) of GIGA-2339
Time frame: SAD: Pre-dose and at multiple timepoints post-dose up to Day 105; MAD: Pre-dose and at multiple timepoints post-dose up to Day 245
SAD and MAD: Systemic Clearance (CL) of GIGA-2339
Time frame: SAD: Pre-dose and at multiple timepoints post-dose up to Day 105; MAD: Pre-dose and at multiple timepoints post-dose up to Day 245
MAD: Serum Concentration at the End of the Dosing Interval (Ctrough) of GIGA-2339
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 245
MAD: AUC Versus Time Curve During the Dosing Interval (AUC0-tau) of GIGA-2339
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 245
MAD: Accumulation Ratio Cmax (ARCmax) of GIGA-2339
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 245
MAD: Accumulation Ratio AUC (ARAUCs) of GIGA-2339
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 245