The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of SYH2062 injection in healthy Chinese volunteers
A Phase 1, randomized, double-Blind, placebo-Controlled study to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of SYH2062 injection after a single administration in healthy subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
46
SYH2062 for sc injection
Normal saline matching volume of SYH2062 doses will be administered
Chinese Academy of Medical Science and Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGNumber of Participants with Adverse Events (AEs)
Time frame: up to approximately 12 months
Change from Baseline in Blood Angiotensinogen (AGT) Level
Time frame: up to approximately 12 months
Change from Baseline in in plasma renin concentration
Time frame: up to approximately 12 months
Change from Baseline in in plasma renin activity
Time frame: up to approximately 12 months
Change from Baseline in in angiotensin I
Time frame: up to approximately 12 months
Change from Baseline in in angiotensin II
Time frame: up to approximately 12 months
Change from Baseline in in plasma aldosterone
Time frame: up to approximately 12 months
To characterize the Cmax of single dose of SYH2062
Time frame: Up to Day 3
To characterize the AUC of single dose of SYH2062
Time frame: Up to Day 3
Number of Participants With Anti- SYH2062 Antibodies
Time frame: up to approximately 3 months
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