Healthy SubjectsPhase 1NCT05227768

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

A Phase 1 study testing VV116 25mg Group, VV116 200mg Group and VV116 400mg 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

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Trial summary

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 25mg Group, VV116 200mg Group and VV116 400mg Group
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteChina
Study dates: 11 Nov 2021to 13 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 14Show 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;
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, Shanghai Municipality, 200031

Other trials in China

About this study

Official title: 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.

Read the 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.).

Conditions: Healthy Subjects
Being tested: VV116 25mg Group, VV116 200mg Group, VV116 400mg Group, VV116 800mg Group, VV116 1200mg Group
Keywords: VV116, Phase I, dose-escalation, Tolerability, Pharmacokinetic

What participants receive

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

VV116 25mg GroupDrug
Also called Placebo
4 subjects will receive VV116 25mg,orally; 2 subjects will receive placebo,orally.
VV116 200mg GroupDrug
Also called Placebo
6 subjects will receive VV116 200mg,orally; 2 subjects will receive placebo,orally.
VV116 400mg GroupDrug
Also called Placebo
6 subjects will receive VV116 400mg,orally; 2 subjects will receive placebo,orally.
VV116 800mg GroupDrug
Also called Placebo
6 subjects will receive VV116 800mg,orally; 2 subjects will receive placebo,orally.
VV116 1200mg GroupDrug
Also called Placebo
6 subjects will receive VV116 1200mg,orally; 2 subjects will receive placebo,orally.

Study groups in NCT05227768
Study group	Role	What they receive
VV116	Experimental	Subjects will receive VV116 orally for single dose. Receives: Drug: VV116 25mg Group; Drug: VV116 200mg Group; Drug: VV116 400mg Group; Drug: VV116 800mg Group; Drug: VV116 1200mg Group
Placebo	Experimental	Subjects will receive placebo orally for single dose. Receives: Drug: VV116 25mg Group; Drug: VV116 200mg Group; Drug: VV116 400mg Group; Drug: VV116 800mg Group; Drug: VV116 1200mg Group

What is being measured

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

Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Measured: 7 days after treatment
Tmax
time at which Cmax occurs
Measured: From time zero up to 48 hours post-dose following oral administration of VV116
Cmax
maximum observed plasma concentration
Measured: From time zero up to 48 hours post-dose following oral administration of VV116
AUC0~t
area under the plasma concentration time curve from time zero to the last measurable concentration
Measured: From time zero up to 48 hours post-dose following oral administration of VV116
AUC0-∞
area under the plasma concentration-time curve from time zero to infinity
Measured: From time zero up to 48 hours post-dose following oral administration of VV116

Secondary outcomes (5)

structural of metabolites
Structure of main metabolites of VV116 in plasma, feces and urin. The main metabolites may include 116-N1 and M2.
Measured: From time zero up to 72 hours post-dose following oral administration of VV116
Ae(total excretion of kidney)
Ae(total excretion of kidney)
Measured: From time zero up to 72 hours post-dose following oral administration of VV116
Ae%(proportion of excretion of kidney)
Ae%(proportion of excretion of kidney)
Measured: From time zero up to 72 hours post-dose following oral administration of VV116
CLr(renal clearance rate)
CLr(renal clearance rate)
Measured: 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.
Cumulative excretion and percentage of VV116 and major metabolites in feces.
Measured: From time zero up to 72 hours post-dose following oral administration of VV116

Timeline

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

11 Nov 202113 Jan 2022

First posted7 Feb 2022
Study start11 Nov 2021
Primary completion13 Jan 2022
Study completion13 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
More trials run by Vigonvita Life SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05227768
Sponsor's protocol ID: VV116-01
Status last verified: May 2022
First submitted: 29 Dec 2021
Last updated: 1 Jun 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05227768
Acronym / sponsor ID: VV116-01
Conditions: Healthy Subjects
Keywords: VV116, Phase I, dose-escalation, Tolerability, Pharmacokinetic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Vigonvita Life SciencesIndustry (pharma, biotech, devices)
Study start: 11 Nov 2021 (actual)
Primary completion: 13 Jan 2022 (actual)
Study completion: 13 Jan 2022 (actual)
First posted: 7 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
VV116	Experimental	Drug: VV116 25mg Group, Drug: VV116 200mg Group, Drug: VV116 400mg Group, Drug: VV116 800mg Group, Drug: VV116 1200mg GroupSubjects will receive VV116 orally for single dose.
Placebo	Experimental	Drug: VV116 25mg Group, Drug: VV116 200mg Group, Drug: VV116 400mg Group, Drug: VV116 800mg Group, Drug: VV116 1200mg GroupSubjects will receive placebo orally for single dose.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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;

Key exclusion criteria (14 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VV116 25mg GroupAlso: Placebo4 subjects will receive VV116 25mg,orally; 2 subjects will receive placebo,orally.	Drug	Placebo, VV116
VV116 200mg GroupAlso: Placebo6 subjects will receive VV116 200mg,orally; 2 subjects will receive placebo,orally.	Drug	Placebo, VV116
VV116 400mg GroupAlso: Placebo6 subjects will receive VV116 400mg,orally; 2 subjects will receive placebo,orally.	Drug	Placebo, VV116
VV116 800mg GroupAlso: Placebo6 subjects will receive VV116 800mg,orally; 2 subjects will receive placebo,orally.	Drug	Placebo, VV116
VV116 1200mg GroupAlso: Placebo6 subjects will receive VV116 1200mg,orally; 2 subjects will receive placebo,orally.	Drug	Placebo, VV116

Primary outcome

Incidence of Treatment-Emergent Adverse Events
Time frame: 7 days after treatment
Incidence of Treatment-Emergent Adverse Events
Tmax
Time frame: From time zero up to 48 hours post-dose following oral administration of VV116
time at which Cmax occurs
Cmax
Time frame: From time zero up to 48 hours post-dose following oral administration of VV116
maximum observed plasma concentration
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
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

5 secondary outcomes

structural of metabolites
Time frame: 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%(proportion of excretion of kidney)
Time frame: 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
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

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gangyi Liu principal investigator

Xuhui Central Hospital, Shanghai

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VV116 25mg Group, VV116 200mg Group and VV116 400mg 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 14 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 1 Jun 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. 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?

Incidence of Treatment-Emergent Adverse Events (time frame: 7 days after treatment). The study lists 5 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 NCT05227768.

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 1 Jun 2022.