D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers

InventisBio

Status and phase: Completed; Phase 1

Conditions: Gout

Treatments: Drug: D-0120

Study type: Interventional

Funder types: Industry

Identifiers

NCT03291782

IBIO-201

Details and patient eligibility

About

This initial clinical study in the US will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation, and sequential cohort study to evaluate the safety, tolerability, PK and PD of D-0120-NA in fasting, healthy volunteers (HVs).

In food effect cohort, subjects will each receive 2 doses of D-0120-NA in an open-label manner; once in the fasted state and once in the fed state.

Enrollment: 39 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects must be medically documented as healthy and acceptable at physical examination.
• Subjects serum uric acid level at screening ≥ 4.5 mg/dL.
• Subjects must have a BMI between 18.0 and 30.0 kg/m2 and a body weight of 50 kg or higher
• Subjects must have all laboratory parameters within the normal range or considered not clinically significant by the principal investigator.
• Subjects must have a normal urinalysis, eGFR, ECG or results considered not clinically significant by the principal investigator.
• Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.

Exclusion criteria

• Any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
• Any history or suspicion of kidney stones.
• Positive for HIV, Hepatitis B, and/or Hepatitis C.
• Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 14 days before Day 1 of study medication dosing.
• Undergone major surgery within 3 months prior to Day 1.
• Women who are pregnant or breastfeeding.
• Subjects who received any investigational test article within 5 half-lives or 30 days prior to Day 1 study medication dosing.
• Subjects who consumed Seville oranges- or grapefruit-containing foods or beverages within 7 days before Day 1 and during the entire study duration.
• Subjects with any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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39 participants in 5 patient groups

D-0120 Dose 1

Experimental group

Description:

D-0120 Dose 1 Patients will get D-0120 single agent or placebo of matching size during dose escalation

Treatment:

Drug: D-0120

D-0120 Dose 2

Experimental group

Description:

D-0120 Dose 2 Patients will get D-0120 single agent or placebo of matching size during dose escalation

Treatment:

Drug: D-0120

D-0120 Dose 3

Experimental group

Description:

D-0120 Dose 3 Patients will get D-0120 single agent or placebo of matching size during dose escalation

Treatment:

Drug: D-0120

D-0120 Dose 4

Experimental group

Description:

D-0120 Dose 4 Patients will get D-0120 single agent or placebo of matching size during dose escalation

Treatment:

Drug: D-0120

D-0120 Dose 5

Experimental group

Description:

D-0120 Dose 5 Patients will get D-0120 single agent once in the fasted state and once in the fed state.

Treatment:

Drug: D-0120