Multiple-dose Escalation Clinical Study of VC005 Tablets in Healthy Subjects

NCT05354752 | Completed Phase 1

• 1 other identifier: VC005-102
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is a randomized, double-blind, single-center, placebo-controlled and multiple-dose escalation Pharmacokinetics study

Conditions

Inflammatory Bowel Diseases

Keywords

healthy subjects

Outcome Measures

Primary Outcomes (5)

• Peak Plasma Concentration (Cmax）

  Day 2

• Area under the plasma concentration versus time curve (AUC)

  Day 2

• Peak time in plasma(Tmax)

  Day 2

• Area under the plasma concentration versus time curve during the dosing interval(AUC0-τ)

  Day 9

• minimum plasma concentration at steady state(Cmin,ss)

  Day 9

Study Arms (2)

VC005 Tablets Dose escalation groups

EXPERIMENTAL

VC005 Tablets groups Repeat doses

Drug: VC005 tablets

VC005 Tablets Placebo groups

PLACEBO COMPARATOR

VC005 Tablets Placebo groups Repeat doses.

Drug: VC005 Placebo tablets

Interventions

VC005 tablets DRUG

VC005 groups repeat administration for 7 days

VC005 Tablets Dose escalation groups

VC005 Placebo tablets DRUG

VC005 placebo groups repeat administration for 7 days

VC005 Tablets Placebo groups

Eligibility Criteria

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

You may qualify if:

• Healthy male or female subjects aged 18 to 45 years old，inclusive
• Male subjects weighing at least 50 kg and female subjects weighing at least 45 kg. Body mass index (BMI) between 18 and 28 kg/m2, inclusive
• During the trial and within 3 months after the completion of the trial (the time should exceed the time required for sperm production), there is no fertility plan, and is willing to use effective contraceptive measures (non hormonal contraceptive measures) and there is no sperm donation and egg donation plan
• Volunteer to participate in the trial and sign an informed consent form
• Subjects who are able to communicate well with the investigator are willing and able to comply with all planned visits, treatment plans, laboratory examinations and other research procedures
• Physical examination and vital signs are normal or abnormal with no clinical significance

You may not qualify if:

• Suspected to be allergic to the study drug or any component in the study drug, or allergic constitution
• abnormal electrocardiogram with clinical significance
• Those who have evidence of atypical hyperplasia or a history of malignant tumor
• Suffer from eye diseases, including history of eye surgery or laser surgery (except laser surgery for myopia)
• Those who have a history of herpes simplex or herpes zoster 3 months before administration
• Have any history or evidence of active tuberculosis (TB) or latent TB infection (TB enzyme-linked immunospot test (T-SPOT. TB) positive), or have a history of previous skin TB test or QuantiFERON TB gold in tube test (GIT analysis) positive
• Known active bacteria, viruses, fungi, parasitic infections or other infections or any infections that require antibiotic treatment or hospitalization (4 weeks before screening), or any acute infections within 2 weeks of baseline
• Those who have participated in clinical trials of any drug or medical device (including the placebo group) within 3 months before screening
• Those who have been vaccinated within 2 weeks before administration, or plan to be vaccinated during the study period
• Those who are usually anorexia, dieting, or have started a significantly abnormal diet (such as dieting) within 4 weeks before screening; those who cannot follow a uniform diet or have difficulty swallowing
• Those who have undergone any surgeries within 6 months before screening
• Have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines within 14 days before screening
• Those who use any drug that inhibits or induces liver enzyme activity within 28 days before administration or during the study period
• Those who were in blood donation within 3 months before screening and donated blood volume ≥400 mL, or received blood transfusion
• Those who with dyslipidemia of clinical significance and coronary heart disease

Sponsors & Collaborators

• Jiangsu vcare pharmaceutical technology co., LTD: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: April 29, 2022
• Study Start: June 18, 2022
• Primary Completion: November 2, 2022
• Study Completion: November 15, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-06

Locations

CN (1)