This was a randomized, double-blind, single-dose, placebo-controlled phase I clinical trial. This study plans to conduct three dose groups of dose 1, dose 2, and dose 3. A total of 32 healthy subjects were planned to be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
HRS-5965 capsule
HRS-5965 capsule placebo
Zhongnan hospital of Wuhan University
Wuhan, Hubei, China
Incidence of subjects with adverse events (AEs)
Incidence of AEs, including any abnormal findings in vital signs, and/or physical examination and/or clinical laboratory assessments and/or 12-lead ECG evaluation.
Time frame: Baseline up to seven days after the last dosing.
QTcF: Baseline and placebo-adjusted QTcF after oral HRS-5965 capsules
Time frame: Baseline up to 24 hours after dosing.
Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration (AUC0-t) for HRS-5965
Time frame: Baseline up to seven days after the last dosing.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞) for HRS-5965
Time frame: Baseline up to seven days after the last dosing.
Maximum plasma concentration (Cmax) for HRS-5965
Time frame: Baseline up to seven days after the last dosing.
Time to reach maximum plasma concentration (Tmax) for HRS-5965
Time frame: Baseline up to seven days after the last dosing.
Terminal half-life (t1/2) for HRS-5965
Time frame: Baseline up to seven days after the last dosing.
Apparent clearance (CL/F) of HRS-5965 for administration subcutaneously
Time frame: Baseline up to seven days after the last dosing.
Apparent volume of distribution (V/F) of HRS-5965 for administration subcutaneously
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline up to seven days after the last dosing.
Complement system alternative pathway (AP) inhibition efficiency
Time frame: Baseline up to seven days after the last dosing.