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

NCT05201690 | Completed Phase 1

• 1 other identifier: VV116-02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Keywords

VV116; Phase I; dose-escalation; Healthy Volunteers; Safety; Tolerability; Pharmacokinetic

Outcome Measures

Primary Outcomes (4)

• 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

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

• Number of participants with laboratory test findings of potential clinical importance

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

• Number of participants with vital signs findings of potential clinical importance

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

• Number of participants with ECG findings of potential clinical importance

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

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

Secondary Outcomes (5)

• Tmax

  Calculated using concentration data collected from predose to 48 hours postdose

• Cmax

  Calculated using concentration data collected from predose to 48 hours postdose

• T1/2

  Calculated using concentration data collected from predose to 48 hours postdose

• AUC0-T

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

• AUC0-∞

  Calculated using concentration data collected from predose to 48 hours postdose

Study Arms (4)

VV116 200 mg Group

EXPERIMENTAL

VV116 200 mg Group

Drug: VV116 200 mg Group

VV116 400 mg Group

EXPERIMENTAL

VV116 400 mg Group

Drug: VV116 400mg Group

VV116 600 mg Group

EXPERIMENTAL

VV116 600 mg Group

Drug: VV116 600mg Group

Placebo

PLACEBO COMPARATOR

VV116 Matching placebo tablets; Multiple doses

Drug: VV116 200 mg Group; Drug: VV116 400mg Group; Drug: VV116 600mg Group

Interventions

VV116 200 mg Group DRUG

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

Placebo; VV116 200 mg Group

VV116 400mg Group DRUG

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

Placebo; VV116 400 mg Group

VV116 600mg Group DRUG

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

Placebo; VV116 600 mg Group

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;
• 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;

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, 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: January 21, 2022
• Study Start: December 14, 2021
• Primary Completion: January 19, 2022
• Study Completion: January 23, 2022
• Last Updated: February 9, 2022

Record last verified: 2021-12

Locations

CN (1)