Atopic Dermatitis
Conditions
Brief summary
This study was designed to evaluate the mass balance and biotransformation after single-dose of \[14C\]VC005 orally in Chinese healthy male volunteers.
Interventions
DRUG[14C]VC005
Take a suspension of 50 mg VC005 ,containing about 120 μCi \[14C\]VC005, in fasting within 5 minutes
Sponsors
Jiangsu vcare pharmaceutical technology co., LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* A healthy male adult. * Age is between 18 and 45, inclusive. * Weight ≥ 50 kg and Body mass index is between 19 and 26, inclusive. * Voluntarily to provide informed consent form. * Willing and able to communicate with investigators and complete the trial according to clinical trial protocol.
Exclusion criteria
* Any abnormal and clinical significant findings to physical examination, vital signs, laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine+occult blood, thyroid function), 12 lead electrocardiogram, chest X-ray (upright position), abdominal ultrasound (liver, gallbladder, pancreas, spleen and kidney), anal directorial rectum examination, and so on. * Tested positive for any one of the following: HBsAg/HBeAg, Anti-HCV IgG, HIV-Ag/Ab or treponema pallidum antibody (Syphilis) . * Volunteers who have to work in radioactive conditions in long time, participated in radio-labeled drug clinical trial or had significant radioactive exposure within one year before the trial, more than 2 times of chest/abdominal CT, or more than 3 times of different types of X-ray exam. * Volunteers are not suitable for this clinical trial, in the opinions of investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative excretion rate of radioactivity in urine | from 0 hour to 216 hours after administration |
| Cumulative excretion rate of radioactivity in feces | from 0 hour to 216 hours after administration |
| Total radioactivity | from 0 hour to 216 hours after administration |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events | From signing the ICF until 10 days after the dosing |
Countries
China
Outcome results
None listed