The primary objective of this phase Ia study is to evaluate the safety and tolerability of single-ascending, subcutaneous (SC) doses of HC022 in healthy subjects. Secondary objectives of study are as follows: To estimate the PK parameters of single-ascending SC doses of HC022 in healthy subjects;To evaluate the immunogenicity of HC022 administered to healthy subjects.
This is a first-in-human study of HC022 to assess safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) effects of single HC022 doses in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
38
Peking Union Medical College Hospital
Beijing, China
NOT_YET_RECRUITINGPeking Union Medical College Hospital
Beijing, China
RECRUITINGThe Clinical Pharmacology Research Center of PUMCH
Beijing, China
RECRUITINGPercentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 20 weeks
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of HC022
Time frame: Up to 20 weeks
Maximum Observed Concentration (Cmax) of HC022
Time frame: Up to 20 weeks
Time to Reach Maximum Observed Concentration (Tmax) of HC022
Time frame: Up to 20 weeks
Terminal Elimination Half-Life (t1/2) of HC022
Time frame: Up to 20 weeks
Apparent Clearance (CL/F) of HC022
Time frame: Up to 20 weeks
Apparent Volume of Distribution (Vz/F) of HC022
Time frame: Up to 20 weeks
Number of Participants Who Develop Serum Anti-HC022 Antibodies
Time frame: Up to 20 weeks
The Clinical Pharmacology Research Center of PUMCH
CONTACT
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