The Mass Balance and Biotransformation Study of [14C] VC005 in Chinese Healthy Adult Male Volunteers
Phase 1
Not yet recruiting
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: [14C]VC005
- Registration Number
- NCT06974292
- Lead Sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 6
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [14C]VC005 [14C]VC005 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Adverse events From signing the ICF until 10 days after the dosing
Trial Locations
- Locations (1)
The First Affiliated Hospital of Suzhou University
🇨🇳Suzhou, Jiangsu, China