- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05201690
Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV116 in Healthy Volunteers
February 8, 2022 updated by: Vigonvita Life Sciences
A Randomized, Double-blinded, Placebo-controlled, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of VV116 After Multiple Ascending Doses Administered Orally to Chinese Healthy Volunteers
This is a randomized, double-blinded, placebo-controlled, single-center phase I clinical trial.
The objective of this study is to evaluate the safety, tolerability, pharmacokinetic profiles of VV116 tablets after multiple ascending doses administered orally to Chinese healthy volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Multiple-dose ascending design is used in the trial, VV116/Placebo is administered sequentially from low-dose to high-dose and each subject can only orally receive one dose level.
There are 3 dose groups (200mg, 400mg, 600mg), investigational product is orally administrated BID for 5.5 days, the last dose is taken in D6 morning.
When 7th day visit after last dose (D12) is completed for previous dose group, investigator and sponsor will evaluate the safety and determine whether the next dose group can be started.
12 subjects will be enrolled in each dose group and the ratio of investigational product to placebo is 3:1.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai, China
- Shanghai Xuhui Central Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects between the ages of 18 and 45 years;
- Body weight no less than 50 kg for male, no less than 45 kg for female; Body Mass Index of 19 to 26kg/m2;
- Physical examination, vital signs examination, laboratory examination, ECG, B-ultrasound and fundus examination results were normal or abnormal without clinical significant;
- Subjects who are willing to take proper contraceptive during the study and within 3 months after the study completed;
- Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form;
Exclusion Criteria:
- Subjects with hypersensitivity to VV116 or any of the excipients;
- Subjects with allergic diseases or allergic constitution;
- Subjects with central nervous system,cardiovascular system,gastrointestinal, respiratory system,urinary,Hematologic System,metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;
- Blood donation or blood loss ≥ 400 mL within 3 months prior to inclusion, or have a history of blood product use history;
- Participated in a clinical study involving another investigational drug within 3 month before the screening visit;
- Taken any prescription drugs, non-prescription drugs, Chinese herbal medicine or health care products within 2 weeks prior to screening;
- Drug or alcohol addicts within 1 year prior to screening, who drink at least twice a day or more than 14 units per week, or who are addicted to alcohol (1 unit ≈200 mL beer with 5% alcohol content, 25 mL spirits with 40% alcohol content or 85 mL wine with 12% alcohol content) ;
- Those who smoke more than 10 cigarettes per day and do not agree to avoid using any tobacco products during the trial period;
- Those who cannot quit smoking or drinking during the trial;
- Those who are positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
- Abnormal and clinically significant chest radiographs (anteroposterior);
- B ultrasound examination showed moderate to severe fatty liver;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeded the upper normal limit (ULN) at screening time or baseline;
- Glomerular filtration rate (eGFR) < 90 mL/min/1.73m2 at screening time or baseline;
- Abnormal ecg at screening or baseline, single QTcF (corrected for heart rate) > 450 ms in men, > 470 ms in women, and/or other clinically significant abnormalities;
- Pregnant or lactating women or male subjects whose spouse has a child care plan within 3 months;
- The investigator believes that there are other factors that are not suitable for participating in this trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VV116 200 mg Group
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Drug: VV116 9 subjects will receive VV116 200 mg, orally, QD12h, 5.5 days ;
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Experimental: VV116 400 mg Group
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Drug: VV116 9 subjects will receive VV116 400 mg, orally, QD12h, 5.5 days ;
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Experimental: VV116 600 mg Group
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Drug: VV116 9 subjects will receive VV116 600 mg, orally, QD12h, 5.5 days ;
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Placebo Comparator: Placebo
VV116 Matching placebo tablets; Multiple doses
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Drug: VV116 9 subjects will receive VV116 200 mg, orally, QD12h, 5.5 days ;
Drug: VV116 9 subjects will receive VV116 400 mg, orally, QD12h, 5.5 days ;
Drug: VV116 9 subjects will receive VV116 600 mg, orally, QD12h, 5.5 days ;
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment emergent treatment-related adverse event(s)
Time Frame: Dosing through follow-up call (7 days after last dose of investigational product)
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Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs
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Dosing through follow-up call (7 days after last dose of investigational product)
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Number of participants with laboratory test findings of potential clinical importance
Time Frame: Dosing through follow-up call (7 days after last dose of investigational product)
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Dosing through follow-up call (7 days after last dose of investigational product)
|
|
Number of participants with vital signs findings of potential clinical importance
Time Frame: Dosing through follow-up call (7 days after last dose of investigational product)
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Dosing through follow-up call (7 days after last dose of investigational product)
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Number of participants with ECG findings of potential clinical importance
Time Frame: Dosing through follow-up call (7 days after last dose of investigational product)
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Number of subjects with change from baseline in electrocardiogram (ECG) parameters
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Dosing through follow-up call (7 days after last dose of investigational product)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tmax
Time Frame: Calculated using concentration data collected from predose to 48 hours postdose
|
Time to reach maximum observed plasma concentration
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Calculated using concentration data collected from predose to 48 hours postdose
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Cmax
Time Frame: Calculated using concentration data collected from predose to 48 hours postdose
|
Maximum observed plasma concentration
|
Calculated using concentration data collected from predose to 48 hours postdose
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T1/2
Time Frame: Calculated using concentration data collected from predose to 48 hours postdose
|
Terminal half life
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Calculated using concentration data collected from predose to 48 hours postdose
|
AUC0-T
Time Frame: Area under the serum concentration time profile from time zero to the time of the last quantifiable concentration.
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Calculated using concentration data collected from predose to 48 hours postdose
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Area under the serum concentration time profile from time zero to the time of the last quantifiable concentration.
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AUC0-∞
Time Frame: Calculated using concentration data collected from predose to 48 hours postdose
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Area under the plasma concentration-time curve from time 0 extrapolated to infinity
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Calculated using concentration data collected from predose to 48 hours postdose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 14, 2021
Primary Completion (Actual)
January 19, 2022
Study Completion (Actual)
January 23, 2022
Study Registration Dates
First Submitted
December 29, 2021
First Submitted That Met QC Criteria
January 20, 2022
First Posted (Actual)
January 21, 2022
Study Record Updates
Last Update Posted (Actual)
February 9, 2022
Last Update Submitted That Met QC Criteria
February 8, 2022
Last Verified
December 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- VV116-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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