AzTrials
AzTrials

Healthy SubjectsPhase 1NCT05201690

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

A Phase 1 study testing VV116 200 mg Group, VV116 400mg Group and VV116 600mg Group in people with Healthy Subjects, run by Vigonvita Life Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
VV116 200 mg Group, VV116 400mg Group and VV116 600mg Group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteChina
Study dates
14 Dec 2021to 23 Jan 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Xuhui Central Hospital

    Shanghai

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
VV116 200 mg Group, VV116 400mg Group, VV116 600mg Group
Keywords
VV116, Phase I, dose-escalation, Healthy Volunteers, Safety, Tolerability, Pharmacokinetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VV116 200 mg GroupDrug

    Drug: VV116 9 subjects will receive VV116 200 mg, orally, QD12h, 5.5 days ;

  • VV116 400mg GroupDrug

    Drug: VV116 9 subjects will receive VV116 400 mg, orally, QD12h, 5.5 days ;

  • VV116 600mg GroupDrug

    Drug: VV116 9 subjects will receive VV116 600 mg, orally, QD12h, 5.5 days ;

Study groups in NCT05201690
Study groupRoleWhat they receive
VV116 200 mg GroupExperimentalVV116 200 mg Group
Receives: Drug: VV116 200 mg Group
VV116 400 mg GroupExperimentalVV116 400 mg Group
Receives: Drug: VV116 400mg Group
VV116 600 mg GroupExperimentalVV116 600 mg Group
Receives: Drug: VV116 600mg Group
PlaceboPlacebo comparatorVV116 Matching placebo tablets; Multiple doses
Receives: Drug: VV116 200 mg Group; Drug: VV116 400mg Group; Drug: VV116 600mg Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment emergent treatment-related adverse event(s)

    Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs

    Measured: Dosing through follow-up call (7 days after last dose of investigational product)

  2. Number of participants with laboratory test findings of potential clinical importance

    Measured: Dosing through follow-up call (7 days after last dose of investigational product)

  3. Number of participants with vital signs findings of potential clinical importance

    Measured: Dosing through follow-up call (7 days after last dose of investigational product)

  4. Number of participants with ECG findings of potential clinical importance

    Number of subjects with change from baseline in electrocardiogram (ECG) parameters

    Measured: Dosing through follow-up call (7 days after last dose of investigational product)

Secondary outcomes (5)

  1. Tmax

    Time to reach maximum observed plasma concentration

    Measured: Calculated using concentration data collected from predose to 48 hours postdose

  2. Cmax

    Maximum observed plasma concentration

    Measured: Calculated using concentration data collected from predose to 48 hours postdose

  3. T1/2

    Terminal half life

    Measured: Calculated using concentration data collected from predose to 48 hours postdose

  4. AUC0-T

    Calculated using concentration data collected from predose to 48 hours postdose

    Measured: Area under the serum concentration time profile from time zero to the time of the last quantifiable concentration.

  5. AUC0-∞

    Area under the plasma concentration-time curve from time 0 extrapolated to infinity

    Measured: Calculated using concentration data collected from predose to 48 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2022
  2. Study start14 Dec 2021
  3. Primary completion19 Jan 2022
  4. Study completion23 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05201690
Sponsor's protocol ID
VV116-02
Status last verified
Dec 2021
First submitted
29 Dec 2021
Last updated
9 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VV116 200 mg Group, VV116 400mg Group and VV116 600mg Group in people with Healthy Subjects, run by Vigonvita Life Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05201690.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in