Actively Recruiting
A Phase I Study of Single and Multiple Doses of VG290131 in Healthy Subjects
Led by Zhejiang Vimgreen Pharmaceuticals, Ltd. · Updated on 2024-07-26
86
Participants Needed
1
Research Sites
58 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang Vimgreen Pharmaceuticals, Ltd.
Lead Sponsor
T
Tigermed Consulting Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability and PK profiles of orally administered VG290131 in healthy subjects. The main questions it aims to answer are: 1. The safety and tolerability of VG290131 when administered orally as a single dose and multiple doses in healthy subjects. 2. The pharmacokinetic (PK) profiles of VG290131 and the food effect on the PK profiles of VG290131 in healthy subjects. Approximately 86 subjects will be enrolled in the study.
CONDITIONS
Official Title
A Phase I Study of Single and Multiple Doses of VG290131 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to comply with protocol required visit schedule and provide written informed consent
- Healthy adult males and females aged 18 to 45 years inclusive at the time of signing informed consent
- Body mass index between 18.0 and 32.0 kg/m2 inclusive
- Medically healthy based on medical history, physical exam, clinical lab tests, vital signs, and 12-Lead ECG
- Male subjects must agree to true abstinence, surgical sterilization, or use condoms plus effective contraception if partner is of childbearing potential, with exceptions for exclusive same-sex relationships
- Female subjects must not be pregnant or breastfeeding and either be of non-childbearing potential or agree to true abstinence or effective contraception from signing informed consent to 3 months after last dose, with negative pregnancy test within 7 days prior to first dose, or be in an exclusively same-sex relationship
You will not qualify if you...
- Known hypersensitivity or allergies to VG290131 or its ingredients
- History or current significant metabolic, endocrine, liver, kidney, blood, lung, heart, gastrointestinal, urological, immune, neurological, or psychiatric disorders with clinical symptoms
- Active or history of serious mental illness requiring current medication, such as schizophrenia, bipolar disorder, or severe depression
- History of stomach or intestinal surgery or diseases affecting drug absorption or excretion (except appendectomy)
- Use of drugs that induce or inhibit cytochrome P450 enzymes or P-glycoprotein substrates within 28 days or 5 half-lives before first dose
- Use of prescription or OTC drugs (except certain hormonal or occasional analgesics) within 14 days or 5 half-lives before first dose
- Participation in other investigational drug trials within 28 days or 5 half-lives before first dose
- Smoking 5 or more cigarettes per day or unable to stop smoking during the study
- Alcohol consumption exceeding 21 units/week for males or 14 units/week for females in past 6 months or positive alcohol breath test on admission
- History of drug abuse in past 12 months or positive drug abuse test at screening
- Consumption of foods that modulate cytochrome P450 or P-gp activity within 72 hours before first dose
- Clinically significant lab abnormalities including high blood pressure, abnormal heart rate, prolonged QT interval, abnormal liver or kidney function
- Active infections including HIV, syphilis, hepatitis B or C
- Blood or plasma donation within 30 days or blood transfusion within 1 year prior to screening
- Difficulty swallowing oral medications
- Inability to tolerate venous access or phlebotomy
- Any condition deemed unsuitable by investigator for study participation or completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
D
Dr. Ana Liza Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
10
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