The Mass Balance and Biotransformation Study of [14C] VC005 in Chinese Healthy Adult Male Volunteers

NCT06974292 | Completed Phase 1

• 1 other identifier: VC005-105
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Adverse events

  From signing the ICF until 10 days after the dosing

Study Arms (1)

[14C]VC005

EXPERIMENTAL

Drug: [14C]VC005

Interventions

[14C]VC005 DRUG

Take a suspension of 50 mg VC005 ,containing about 120 μCi \[14C\]VC005, in fasting within 5 minutes

[14C]VC005

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu vcare pharmaceutical technology co., LTD: lead

Study Sites (1)

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Liyan Miao

  First Affiliated Hospital of Suzhou Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 15, 2025
• Study Start: May 26, 2025
• Primary Completion: June 3, 2025
• Study Completion: June 3, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-05

Locations

CN (1)