NCT05138770CompletedPhase 1
Randomized, Double-blind, Dose-escalation, Placebo-controlled Single Administration Phase Ia Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics and Food Effects of VC005 Tablets in Healthy Subjects
Jiangsu vcare pharmaceutical technology co., LTD1 site in 1 country78 target enrollmentStarted: November 18, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Peak time in plasma(Tmax)
Study Overview
Brief Summary
This clinical trial consists of two parts：1. a randomized, double-blind, single-center, placebo-controlled, dose-escalation PK study; 2. food effects and drug metabolism transformation study.
The main purpose of this trial is to evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics and Food effects of VC005 Tablets in healthy subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •Pregnant and lactating females, or females who have a positive pregnancy test
- •Those who have difficulty in blood collection or cannot tolerate venipuncture, and those who have a history of fainting needles and bleeding
- •Those who smoke ≥ 5 cigarettes per day within 3 months before screening and cannot stop using any tobacco products from the end of screening to before enrollment and during the test
- •Those who drink more than 14 units of alcohol per week within 3 months prior to administration (1 unit of alcohol ≈ 360 mL beer or 45 mL 40% alcohol spirits or 150 mL wine), or those who cannot abstain from alcohol during the study
- •Those who have taken any food or drink that affects absorption, distribution, metabolism, and excretion of the drug within 24 hours before administration, such as food or drink containing caffeine (such as chocolate) and xanthine
- •Those who have consumed pithya , mango, grapefruit, lime, star fruit, or food or beverage prepared therefrom 2 weeks before the first administration
- •Clinically significant clinical laboratory abnormalities or other clinically significant diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, tumor, pulmonary, immunological, psychiatric or cardiovascular diseases)
- •Those who are positive in urine drug and alcohol test
- •Hepatitis B surface antigen, hepatitis C antibody / hepatitis C core antigen, HIV antigen / antibody, syphilis antibody positive
- •Subjects with other factors not suitable for the trial considered by the investigator
Arms & Interventions
VC005 Tablets Dose escalation groups: 1、5、10、25、50、100mg
Experimental
VC005 Tablets 1、5、10、25、50、100mg, qd
Intervention: VC005 Tablets (Drug)
VC005 Tablets Placebo Dose escalation groups: 1、5、10、25、50、100mg
Placebo Comparator
VC005 Tablets Placebo 1、5、10、25、50、100mg, qd
Intervention: VC005 Tablets Placebo (Drug)
VC005 Tablets food effects group
Experimental
VC005 Tablets, qd
Intervention: VC005 Tablets food effects group (Drug)
Outcomes
Primary Outcomes
Peak time in plasma(Tmax)
Time Frame: Day 4
Accumulative urine excretion rate
Time Frame: Day 4
Accumulative fecal excretion rate
Time Frame: Day 4
Peak Plasma Concentration (Cmax）
Time Frame: Day 4
Area under the plasma concentration versus time curve (AUC)
Time Frame: Day 4
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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