This is a first in human clinical trial with HHT120. The purpose of this study is to characterize the safety, pharmacokinetic (PK) and Pharmacodynamic (PD) profile of single and multiple twice-daily doses of HHT120 in healthy Subjects and to assess the effects of food on the PK profile of single-dose of HHT120 in healthy Subjects.
There are 3 parts of the study: Part 1: Single asending dose trial; Part 2: Multiple asending dose trial; Part 3: Food effect trial ( 2-Period Crossover)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
Vital signs
Abnormal changes in vital signs from baseline
Time frame: Up to Day 14
Physical examination
Abnormal changes in physical examination from baseline
Time frame: Up to Day 14
Laboratory examination
Abnormal changes in laboratory examination from baseline
Time frame: Up to Day 14
Electrocardiogram
Abnormal changes in electrocardiogram from baseline
Time frame: Up to Day 14
Chest radiography
Abnormal changes in chest radiography from baseline
Time frame: Up to Day 14
Adverse events
Incidence of adverse events, serious adverse events, adverse events of special interest
Time frame: Up to Day 14
Maximum tolerable dose (MTD)
Maximum tolerable dose (MTD)
Time frame: Up to Day 14
Part 1: Cmax
Cmax of single dose administration
Time frame: Up to Day 4
Part 1: Tmax
Tmax of single dose administration
Time frame: Up to Day 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Part 1: t1/2
t1/2 of single dose administration
Time frame: Up to Day 4
Part 1: Vz/F
Vz/F of single dose administration
Time frame: Up to Day 4
Part 1: CLz/F
CLz/F of single dose administration
Time frame: Up to Day 4
Part 1: AUC
AUC of single dose administration
Time frame: Up to Day 4
Part 2: Cmax,ss
Cmax,ss of multiple dose administration
Time frame: Up to Day 10
Part 2: AUC,ss
AUC,ss of multiple dose administration
Time frame: Up to Day 10
Part 2: Tmax,ss
tmax,ss of multiple dose administration
Time frame: Up to Day 10
Part 2: Cmin,ss
Cmin,ss of multiple dose administration
Time frame: Up to Day 10
Part 2: Cav,ss
Cav,ss of multiple dose administration
Time frame: Up to Day 10
Part 2: t1/2
t1/2 of multiple dose administration
Time frame: Up to Day 10
Part 2: MRTss
MRTss of multiple dose administration
Time frame: Up to Day 10
Part 2: Accumulation index
accumulation index of multiple dose administration
Time frame: Up to Day 10
Part 1 & Part 2: aPTT, INR and TT
Maximum percentage of aPTT, INR and TT to baseline (Emax)
Time frame: Up to Day 10
Part 3: Cmax in fasted or fed condition
Geometric mean ratios of Cmax (fed/fasted) and their 90% confidence intervals
Time frame: Up to Day 4
Part 3: AUC in fasted or fed condition
Geometric mean ratios of AUC (fed/fasted) and their 90% confidence intervals
Time frame: Up to Day 4