Status:
COMPLETED
The Mass Balance and Biotransformation Study of [14C] VC005 in Chinese Healthy Adult Male Volunteers
Lead Sponsor:
Jiangsu vcare pharmaceutical technology co., LTD
Conditions:
Atopic Dermatitis
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2025
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06974292
Start Date
May 26 2025
End Date
June 3 2025
Last Update
July 11 2025
Active Locations (1)
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1
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China