A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Food Effects of a Single Oral VV119 Capsule in Healthy Chinese Volunteers

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study will consist of 2 parts: Part Ⅰ - Single Ascending Dose (SAD) study, Part Ⅱ - Food Effect (FE) study

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• Males:aged 18 to 45 years old, males ,Body weight no less than 50.0 kg ; females :Aged 18 to 60 years old ,Body weight no less than 45.0 kg ,Body Mass Index of 19.0 to 26.0kg/m2,

• Medically healthy, Physical examination, vital signs examination, laboratory examination, electrocardiogram examination results were normal or abnormal without clinical significance,

• Males subjects who are willing to take effective contraceptive during the study and within 3 months after the study completed; females not of child-bearing potential,

• 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.

Locations
Other Locations
China
Beijing Anding Hospital of Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Huaqing Duan
huaqing.duan@vigonvita.cn
+8618061926005
Time Frame
Start Date: 2023-10-27
Estimated Completion Date: 2025-12
Participants
Target number of participants: 82
Treatments
Experimental: Part Ⅰ - Single Ascending Dose (SAD) study: Experimental
Subjects will receive VV119 orally for single dose.
Experimental: Part Ⅰ - Single Ascending Dose (SAD) study: Placebo
Subjects will receive VV119 placebo orally for single dose.
Experimental: Part Ⅱ - Food Effect (FE) study: Experimental
Subjects will receive VV119 orally for single dose.
Related Therapeutic Areas
Sponsors
Leads: Vigonvita Life Sciences

This content was sourced from clinicaltrials.gov

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