Status:
COMPLETED
Phase I Study of D-0120 to Evaluate Safety and PK/PD Study in Healthy Volunteers
Lead Sponsor:
InventisBio Co., Ltd
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This phase 1 study is a randomized, double-blind, placebo controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy volunteers.
Eligibility Criteria
Inclusion
- Subjects must be medically documented as healthy at physical examination
- Moderate smokers or non-smokers
- Subjects must be between the ages of 18 and 60
- Subject must have a BMI between 18.0 and 30.0 kg/m2 (inclusive)
- Subjects must have a body weight of 50kg or higher for males and 45kg or higher for females
- Females must be non-pregnant and non-lactating, and either surgically sterile at least 6 months prior to the first study drug administration or post-menopausal for 12 months or greater
- Male subjects who are not vasectomized for at least 6 months, and who are sexually active with non-sterile female partner must be willing to use an acceptable contraceptive method throughout the study and for 90 days after the last study drug administration
- Male subjects with a pregnant partner must agree to use a condom from the first dosing until at least 90 days after the last study administration
- Subjects must have a complete blood count and platelet count within the normal range
- Subjects must have a normal urinalysis
- Subjects must have a normal estimated glomerular filtration rate
- Subjects must have a normal ECG
- Subjects must be able to understand the study procedures, risks involved and be able to comply with the study and follow-up procedures
- Male subjects must be willing not to donate sperm until 90 days following the last study drug administration
Exclusion
- Subjects with any history or clinical manifestations of disorders
- Subjects who have any history or suspicion of kidney stones
- Subjects who are HIV, Hep B or Hep C positive
- History of significant allergic reactions to any drug
- Clinically significant ECG abnormalities
- History of significant drug abuse within 1 year prior to screening or use of soft drugs within 3 months prior to screening or hard drugs within 1 year prior to screening
- Subjects who have used prescription dugs, over the counter drugs or herbal remedies within 14 days before day 1
- Positive urine drug screen, alcohol breath at screening
- Subjects had undergone major surgery within 3 months
- Women who are pregnant or breastfeeding
- History of significant alcohol abuse
- Subjects who consumed Seville oranges-or grapefruit-containing food or beverages within 7 days before Day 1 and during the entire study duration.
- Subjects with any condition that, in the judgement of the investigator, would place him/her at undue risk
- Participation in a clinical research study involving the administration of an investigation or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to first dose
- Donation of plasma within 7 days prior to dosing
Key Trial Info
Start Date :
September 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04097405
Start Date
September 18 2019
End Date
November 18 2020
Last Update
February 10 2021
Active Locations (1)
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1
Syneos Health
Miami, Florida, United States, 33163