Clinical trial NCT04097405: Phase I Study of D-0120 to Evaluate Safety and PK/PD Study in Healthy Volunteers
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, and Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of D-0120 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: InventisBio Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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 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

Primary outcomes:
measure: The number of subjects with treatment related adverse events as assessed
timeFrame: 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)
Secondary outcomes:
measure: Time to observed Cmax (Tmax)for D-0120
timeFrame: Timeframe: Day 1-Day7
measure: Area under the plasma concentration-time curve (AUC) for D-0120
timeFrame: Day 1-Day 7
measure: Maximum Observed Plasma Concentration (Cmax) of D-0120
timeFrame: Day 1-Day 7
Other outcomes:
Locations:
city: Miami
country: United States
facility: Syneos Health
state: Florida
Study officials:
References: