Safety and Pharmacokinetics Study of Single Ascending Doses of VV116 in Healthy Volunteers

May 31, 2022 updated by: Vigonvita Life Sciences

A Dose-escalation, Single-center, Randomized, Double-blinded, Placebo-controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profiles of VV116 Administered Orally to Chinese Healthy Volunteers

The study consists of 5 dose groups, starting at 25 mg, 6 subjects in 25 mg group, and 8 subjects in each other group (male or female), randomly assigned to study drug or placebo group to evaluate the safety, tolerability and PK characteristics. The subject number of single dose group may increase or decrease depending on the safety and PK data obtained. The dose levels are planned at 25 mg, 200 mg, 400 mg, 800 mg and 1200 mg. Based on observed tolerability and safety data or obtained PK data, adjustments are allowed at all dose levels in the clinical trial.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

4 subjects in the 25 mg dose group will receive VV116 tablets and the other 2 subjects will receive placebo. In other dose groups, 6 subjects in each group will receive VV116 tablets and 2 subjects will receive placebo. 25mg,800mg and 1200 mg dose group will be given by sentinel administration (i.e. 1 study drug, 1 placebo). Subjects who receive sentinel administration will be observed for 48 hours and investigator will evaluate the safety parameters (including symptoms, vital signs, physical examination, etc.).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Shanghai Xuhui Central Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy subjects between the ages of 18 and 45 years;
  2. Body weight no less than 50 kg for male, no less than 45 kg for female; Body Mass Index of 19 to 26kg/m2;
  3. Physical examination, vital signs examination, laboratory examination, ECG, B-ultrasound and fundus examination results were normal or abnormal without clinical significant;
  4. Subjects who are willing to take proper contraceptive during the study and within 3 months after the study completed;
  5. 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:

  1. Subjects with hypersensitivity to VV116 or any of the excipients;
  2. Subjects with allergic diseases or allergic constitution;
  3. 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;
  4. Blood donation or blood loss ≥ 400 mL within 3 months prior to inclusion, or have a history of blood product use history;
  5. Participated in a clinical study involving another investigational drug within 3 month before the screening visit;
  6. Taken any prescription drugs, non-prescription drugs, Chinese herbal medicine or health care products within 2 weeks prior to screening;
  7. 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) ;
  8. Those who smoke more than 10 cigarettes per day and do not agree to avoid using any tobacco products during the trial period;
  9. Those who cannot quit smoking or drinking during the trial;
  10. Those who are positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;
  11. Abnormal and clinically significant chest radiographs (anteroposterior);
  12. B ultrasound examination showed moderate to severe fatty liver;
  13. Pregnant or lactating women or male subjects whose spouse has a child care plan within 3 months;
  14. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VV116
Subjects will receive VV116 orally for single dose.
Drug: VV116 25mg Group
4 subjects will receive VV116 25mg,orally; 2 subjects will receive placebo,orally.
Other Names:
  • Placebo
Drug: VV116 200mg Group
6 subjects will receive VV116 200mg,orally; 2 subjects will receive placebo,orally.
Other Names:
  • Placebo
Drug: VV116 400mg Group
6 subjects will receive VV116 400mg,orally; 2 subjects will receive placebo,orally.
Other Names:
  • Placebo
Drug: VV116 800mg Group
6 subjects will receive VV116 800mg,orally; 2 subjects will receive placebo,orally.
Other Names:
  • Placebo
Drug: VV116 1200mg Group
6 subjects will receive VV116 1200mg,orally; 2 subjects will receive placebo,orally.
Other Names:
  • Placebo
Experimental: Placebo
Subjects will receive placebo orally for single dose.
Drug: VV116 25mg Group
4 subjects will receive VV116 25mg,orally; 2 subjects will receive placebo,orally.
Other Names:
  • Placebo
Drug: VV116 200mg Group
6 subjects will receive VV116 200mg,orally; 2 subjects will receive placebo,orally.
Other Names:
  • Placebo
Drug: VV116 400mg Group
6 subjects will receive VV116 400mg,orally; 2 subjects will receive placebo,orally.
Other Names:
  • Placebo
Drug: VV116 800mg Group
6 subjects will receive VV116 800mg,orally; 2 subjects will receive placebo,orally.
Other Names:
  • Placebo
Drug: VV116 1200mg Group
6 subjects will receive VV116 1200mg,orally; 2 subjects will receive placebo,orally.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: 7 days after treatment
Incidence of Treatment-Emergent Adverse Events
7 days after treatment
Tmax
Time Frame: From time zero up to 48 hours post-dose following oral administration of VV116
time at which Cmax occurs
From time zero up to 48 hours post-dose following oral administration of VV116
Cmax
Time Frame: From time zero up to 48 hours post-dose following oral administration of VV116
maximum observed plasma concentration
From time zero up to 48 hours post-dose following oral administration of VV116
AUC0~t
Time Frame: From time zero up to 48 hours post-dose following oral administration of VV116
area under the plasma concentration time curve from time zero to the last measurable concentration
From time zero up to 48 hours post-dose following oral administration of VV116
AUC0-∞
Time Frame: From time zero up to 48 hours post-dose following oral administration of VV116
area under the plasma concentration-time curve from time zero to infinity
From time zero up to 48 hours post-dose following oral administration of VV116

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
structural of metabolites
Time Frame: From time zero up to 72 hours post-dose following oral administration of VV116
Structure of main metabolites of VV116 in plasma, feces and urin. The main metabolites may include 116-N1 and M2.
From time zero up to 72 hours post-dose following oral administration of VV116
Ae(total excretion of kidney)
Time Frame: From time zero up to 72 hours post-dose following oral administration of VV116
Ae(total excretion of kidney)
From time zero up to 72 hours post-dose following oral administration of VV116
Ae%(proportion of excretion of kidney)
Time Frame: From time zero up to 72 hours post-dose following oral administration of VV116
Ae%(proportion of excretion of kidney)
From time zero up to 72 hours post-dose following oral administration of VV116
CLr(renal clearance rate)
Time Frame: From time zero up to 72 hours post-dose following oral administration of VV116
CLr(renal clearance rate)
From time zero up to 72 hours post-dose following oral administration of VV116
Cumulative excretion and percentage of VV116 and major metabolites in feces.
Time Frame: From time zero up to 72 hours post-dose following oral administration of VV116
Cumulative excretion and percentage of VV116 and major metabolites in feces.
From time zero up to 72 hours post-dose following oral administration of VV116

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vigonvita Life Sciences

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VV116-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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