Healthy Volunteers
Conditions
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.
Interventions
DRUGD-0120
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo
DRUGPlacebo oral tablet
Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo
Sponsors
InventisBio Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double Blind, placebo controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of subjects with treatment related adverse events as assessed | Reporting of adverse events starts at enrollment through the end of the follow up period (14 days (cohorts 1-4) and 16 days (cohort 6) | Data will include clinical observations, ECG, clinical chemistry/hematology/urinalysis and vital signs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to observed Cmax (Tmax)for D-0120 | Timeframe: Day 1-Day7 | Blood samples will be collected to assess plasma concentrations of D-0120 at a series of timepoints to derive Tmax |
| Area under the plasma concentration-time curve (AUC) for D-0120 | Day 1-Day 7 | Blood samples will be collected to assess plasma concentration of D-0120 at a series of timepoints to derive AUC |
| Maximum Observed Plasma Concentration (Cmax) of D-0120 | Day 1-Day 7 | Blood samples will be collect to assess plasma concentrations of D-0120 at a series of timepoints to derive Cmax |
Countries
United States
Outcome results
None listed