A phase I clinical study to evaluate the safety ,tolerability, pharmacokinetic and pharmocodynamic characteristics of a single subcutaneous does of IBI3016 in Japanese participants with mild to moderate hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
single doses of IBI3016 administered by subcutaneous injection
single doses of IBI3016 administered by subcutaneous injection
single doses of IBI3016 administered by subcutaneous injection
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Japan
RECRUITINGNumber of Participants with Adverse Events
Time frame: Through 24 weeks, up to approximately 12 months
Plasma Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI3016
Time frame: Predose, early post-dose and up to 48 hours postdose
Plasma PK: Area Under the Concentration Versus Time Curve (AUC) of IBI3016
Time frame: Predose, Day 1, and up to 48 hours postdose
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) assessed by OBP and ABPM
Time frame: Baseline, Month 3 and Month 6
Change from baseline in serum angiotensinogen (AGT) concentration
Time frame: Through 24 weeks, up to approximately 12 months
Urine PK parameter: drug accumulation
Time frame: Predose, Day 1, and up to 48 hours postdose
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single doses of IBI3016 administered by subcutaneous injection
single doses of IBI3016 administered by subcutaneous injection