Phase I Clinical Trial to Evaluate the Tolerance, Safety and Pharmacokinetics of Germinal Peptide Eye Drops in Healthy Volunteers.
The subjects enrolled in this study are healthy volunteers, divided into single dose groups and multiple doses groups with dose escalation.The study is designed to assign the subjects to five single-dose groups from low to high (0.0005%, 0.001%, 0.002%, 0.004% and 0.008%), and three multiple-dose groups (0.002%, 0.004% and 0.008%), with both male and female subjects in each group. This clinical trial is a double-blind design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%
Xiuli Zhao
Beijing, China
ocular symptoms
Ocular signs: conjunctival congestion, corneal epithelial injury, conjunctival edema, anterior chamber glow.
Time frame: Within two days after administration
Area under curve (0-t)
AUC(0-t)
Time frame: Within two days after administration
Area under curve(0-∞)
AUC(0-∞)
Time frame: Within two days after administration
Peak concentration
Cmax
Time frame: Within two days after administration
Peak time
Tmax
Time frame: Within two days after administration
Half life
t1/2
Time frame: Within two days after administration
Apparent volume of distribution
Vd
Time frame: Within two days after administration
Elimination rate constant
Kel
Time frame: Within two days after administration
Mean residence time
MRT
Time frame: Within two days after administration
Clearance
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CL or CL/F
Time frame: Within two days after administration
slit lamp examination
Examination of cornea, conjunctiva, sclera, lens and vitreous body.
Time frame: Within two days after administration
fundus examination
Observe the change of fundus.
Time frame: Within two days after administration
intraocular pressure
Observe the change of intraocular pressure.
Time frame: Within two days after administration
vision
Observe the change of vision.
Time frame: Within two days after administration
12-lead ECG
Observe the change of 12-lead ECG.
Time frame: Within two days after administration
AE
Observe the occurrence and record of AE.
Time frame: Within two days after administration
corneal fluorescein staining
Observe the change of corneal fluorescein staining.
Time frame: Within two days after administration