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

NCT05227768 | Completed Phase 1

• 1 other identifier: VV116-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects

Keywords

VV116; Phase I; dose-escalation; Tolerability; Pharmacokinetic

Outcome Measures

Primary Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events

  Incidence of Treatment-Emergent Adverse Events

  7 days after treatment

• Tmax

  time at which Cmax occurs

  From time zero up to 48 hours post-dose following oral administration of VV116

• Cmax

  maximum observed plasma concentration

  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

  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

  From time zero up to 48 hours post-dose following oral administration of VV116

Secondary Outcomes (5)

• structural of metabolites

  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)

  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.

  From time zero up to 72 hours post-dose following oral administration of VV116

Study Arms (2)

VV116

EXPERIMENTAL

Subjects will receive VV116 orally for single dose.

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.

Drug: VV116 25mg Group; Drug: VV116 200mg Group; Drug: VV116 400mg Group; Drug: VV116 800mg Group; Drug: VV116 1200mg Group

Interventions

VV116 25mg Group DRUG

4 subjects will receive VV116 25mg,orally; 2 subjects will receive placebo,orally.

Also known as: Placebo

Placebo; VV116

VV116 200mg Group DRUG

6 subjects will receive VV116 200mg,orally; 2 subjects will receive placebo,orally.

Also known as: Placebo

Placebo; VV116

VV116 400mg Group DRUG

6 subjects will receive VV116 400mg,orally; 2 subjects will receive placebo,orally.

Also known as: Placebo

Placebo; VV116

VV116 800mg Group DRUG

6 subjects will receive VV116 800mg,orally; 2 subjects will receive placebo,orally.

Also known as: Placebo

Placebo; VV116

VV116 1200mg Group DRUG

6 subjects will receive VV116 1200mg,orally; 2 subjects will receive placebo,orally.

Also known as: Placebo

Placebo; VV116

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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;
• 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.

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Interventions

GS-621763; Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Gangyi Liu

  Shanghai Xuhui Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: February 7, 2022
• Study Start: November 11, 2021
• Primary Completion: January 13, 2022
• Study Completion: January 13, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)