This is a dose escalation trial. The dosing regimen involves a single-dose study. This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetic characteristics of TQC3927 powder for inhalation in healthy adults subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
TQC3927 is a targeted inhibitor.
TQC3927 powder for inhalation placebo contains no active substance.
China Japan Friendship Hospital
Beijing, Beijing Municipality, China
Adverse events (AE)
The occurrence of all adverse events (AE).
Time frame: From the use of the investigational drug until the last study visit, up to Day 9.
Serious adverse events (SAE)
The occurrence of all serious adverse events (SAE).
Time frame: From the use of the investigational drug until the last study visit, up to Day 9.
Abnormal security check
The frequency, incidence, and severity of laboratory tests, vital signs, physical examinations, electrocardiogram examinations, etc.
Time frame: From the use of the investigational drug until the last study visit, up to Day 9.
Pharmacokinetics:Peak concentration (Cmax)
The Cmax is the maximum observed plasma concentration of study drug.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Area Under the Concentration-Time Curve From 0 to Last Observation (AUC [0-t])
To characterize the pharmacokinetics of TQC3927 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity])
To characterize the pharmacokinetics of TQC3927 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Time to reach maximum (peak) plasma concentration following drug administration (Tmax)
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To characterize the pharmacokinetics of TQC3927 by assessment of time to reach maximum plasma concentration after single and multiple dosing
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose
Half-life (t1/2)
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Apparent volume of distribution(Vd/F)
Apparent volume of distribution of the TQC3927 in plasma.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Apparent clearance (CLz/F)
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
End elimination rate (λz)
Derived from semi logarithmic linear regression of eliminating phase concentration points.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Residual area percentage of the TQC3927 (AUC_%Extrap)
Residual area percentage of the TQC3927 in plasma
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose
Mean residence time from zero to last measurable concentration (MRT0-t)
The average residence time from 0:00 to the last measurable concentration time point.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Mean residence time from zero to infinity (MRT0-∞)
Average residence time from 0:00 to infinity.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Accumulated excretion of drugs in urine and feces (Aecum)
Accumulated excretion of drugs in urine and feces from zero to time t.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Accumulated excretion of drugs in urine (Aeu,cum)
Accumulated excretion of drugs in urine from zero to time t.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Accumulated excretion of drugs in feces(Aef,cum)
Accumulated excretion of drugs in feces from zero to time t.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Renal clearance (CLr)
The ability of the kidneys to clear certain substances from plasma within 1 minute.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Total drug excretion ratio in urine and feces (Fe%)
The total excretion ratio of drugs in urine and feces from zero to time t.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Drug excretion ratio in urine (Fe%u)
The proportion of drug excretion in urine from zero to time t.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.
Drug excretion ratio in feces (Fe%f)
The proportion of drug excretion in feces from zero to time t.
Time frame: Single Day1: pre-dose, at 5,15,30,45 minutes,1,2,4,6,8,12,24,36,48,72 hours after-dose.