Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
InventisBio Co., Ltd
Age
18–60
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Phase I Study of D-0120 to Evaluate Safety and PK/PD Study in Healthy Volunteers
