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CompletedNCT06974292Updated Jul 11, 2025

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

A Phase 1 interventional study of [14C]VC005 in Atopic Dermatitis, sponsored by Jiangsu vcare pharmaceutical technology co., LTD. Completed at 1 site in China. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-11.

Sponsored by Jiangsu vcare pharmaceutical technology co., LTD · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Atopic Dermatitis

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03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 6 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Jiangsu vcare pharmaceutical technology co., LTD is the lead sponsor of 34 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    [14C]VC005

    Drug: [14C]VC005

Interventions

  • Drug[14C]VC005

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

06

What researchers measure

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

07

Study locations

1 site
  • The First Affiliated Hospital of Suzhou University
    Suzhou, Jiangsu, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06974292
Lead sponsor
Jiangsu vcare pharmaceutical technology co., LTD
Responsible party
Sponsor
First posted
May 15, 2025
Start date
May 26, 2025
Primary completion
Jun 3, 2025
Completion
Jun 3, 2025
Last update
Jul 11, 2025

Study contacts

Liyan Miao
principal investigator · First Affiliated Hospital of Suzhou Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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