This study is a single-center, randomized, double-blind, placebo-controlled, single dose escalation design to evaluate the safety, tolerability, and pharmacokinetic characteristics of BT-114143 Injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
PKU Care Luzhong Hospital
Zibo, Shandong, China
Safety and tolerability of BT-114143
The number of Treatment-Emergent Adverse Events (TEAEs) with a severity of Grade 2 or higher in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Time frame: For single administration, the follow-up will last until Day 15 after dosing; for multiple administrations, the follow-up will last until Day 21 after dosing.
Cmax
Maximum Concentration
Time frame: 15 days after administration
AUC
Area Under the Concentration-Time Curve
Time frame: 15 days after administration
t1/2
Half-Life
Time frame: 15 days after administration
CL
Clearance
Time frame: 15 days after administration
Vz
Volume of Distribution at Steady State
Time frame: 15 days after administration
Changes in Plasminogen Activity Results from Baseline
Blood samples will be collected to determine the changes in plasminogen activation over time.
Time frame: 72 hours after administration
Changes in Thromboelastography (TEG) Parameters
Blood samples will be collect at each timepoints and TEG parameter (including R, K, Angle, MA, LY30, and CI values) will be measured to determine coagulation function of each subject.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
6 subjects will receive a single dose of BT-114143 injection at 0.3 mg/kg.
6 subjects will receive a single dose of BT-114143 injection at 0.6 mg/kg.
6 subjects will receive a single dose of BT-114143 injection at 1.2 mg/kg.
6 subjects will receive a single dose of BT-114143 injection at 2.4 mg/kg.
6 subjects will receive a single dose of BT-114143 injection at 4.8 mg/kg.
6 subjects will receive a single dose of BT-114143 injection at 8.4 mg/kg.
6 subjects will receive a single dose of BT-114143 injection at 12.6 mg/kg.
6 subjects will receive a single dose of BT-114143 injection at 15 mg/kg.
Except that the S1 dose group was a pilot study group with 1 subject matched to receive a placebo, all other dose groups were each matched with 2 subjects who received placebo treatment as controls.
Time frame: 72 hours after administration
Prothrombin Time(PT)
the trend of change in PT from baseline
Time frame: 15 days after administration
Activated Partial Thromboplastin Time(APTT)
The change in Activated Partial Thromboplastin Time (APTT) from baseline
Time frame: 15 days after administration
International Normalized Ratio(INR)
The change in INR (International Normalized Ratio) from baseline
Time frame: 15 days after administration
Fibrinogen(FIB)
The change in FIB (Fibrinogen) from baseline
Time frame: 15 days after administration
Thrombin Time(TT)
The change in TT (Thrombin Time) from baseline
Time frame: 15 days after administration
D-Dimer
The change in D-Dimer (D-Dimer) from baseline
Time frame: 15 days after administration