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

NCT03291782 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IBIO-201
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Adverse Events and changes of Laboratory, Electrocardiogram, and Vital Signs

  2 weeks

Secondary Outcomes (7)

• Pharmacokinetic: area under the plasma concentration versus time curve (AUC)

  Day-1 through 3

• Pharmacokinetic: maximum plasma drug concentration (Cmax)

  Day-1 through 3

• Pharmacokinetic: Time to reach the Cmax (Tmax)

  Day-1 through 3

• Pharmacokinetic: Apparent terminal half-life (t1/2)

  Day-1 through 3

• Pharmacokinetic: Apparent oral clearance (CL/F)

  Day-1 through 3

Study Arms (5)

D-0120 Dose 1

EXPERIMENTAL

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

Drug: D-0120

D-0120 Dose 2

EXPERIMENTAL

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

Drug: D-0120

D-0120 Dose 3

EXPERIMENTAL

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

Drug: D-0120

D-0120 Dose 4

EXPERIMENTAL

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

Drug: D-0120

D-0120 Dose 5

EXPERIMENTAL

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

Drug: D-0120

Interventions

D-0120 DRUG

oral, single dose

D-0120 Dose 1; D-0120 Dose 2; D-0120 Dose 3; D-0120 Dose 4; D-0120 Dose 5

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (1)

Covance Daytona Beach Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hugh Coleman, MD

  Covance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 25, 2017
• Study Start: September 13, 2017
• Primary Completion: April 6, 2018
• Study Completion: August 6, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-06

Locations

US (1)