Phase I Study of D-0120 to Evaluate Safety and PK/PD Study in Healthy Volunteers

InventisBio

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: D-0120; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04097405

IBIO-203

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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40 participants in 3 patient groups, including a placebo group

D-0120 Dose Ascending Cohorts 1-4

Active Comparator group

Description:

D-0120 dose daily for up to 7 days.

Treatment:

Drug: D-0120

Placebo Dose Ascending Cohorts 1-4

Placebo Comparator group

Description:

Placebo dose daily for up to 7 days

Treatment:

Drug: Placebo oral tablet

D-0120/Uric Acid Lowering Agent Cohort 6

Experimental group

Description:

D-0120 in combination with a uric acid lowering agent for up to 7 days of combination therapy

Treatment:

Drug: D-0120