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NCT Number: NCT06974292

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

This study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]VC005 orally in Chinese healthy male volunteers.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[14C]VC005

Drug

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

Primary outcomes

  1. Cumulative excretion rate of radioactivity in urine

    Time frame: from 0 hour to 216 hours after administration

  2. Cumulative excretion rate of radioactivity in feces

    Time frame: from 0 hour to 216 hours after administration

  3. Total radioactivity

    Time frame: from 0 hour to 216 hours after administration

Secondary outcomes

  1. Adverse events

    Time frame: From signing the ICF until 10 days after the dosing

Sponsors and collaborators

Lead sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 15, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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