D-0120 Safety and PK/PD Study in China

NCT03923868 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IBIO-202
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 6

Brief Summary

It is a randomized, double-blind, placebo-controlled, multiple-administration, multiple-dose, dose-escalating, phase Ib/IIa clinical study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy subjects and hyperuricemia patients (gout or asymptomatic) in China.

Conditions

Hyperuricemia or Gout

Outcome Measures

Primary Outcomes (1)

• The number of subjects with treatment-related adverse events as assessed

  Data will include clinical observations, ECG parameters, clinical chemistry and haematology and vital signs assessed as the number of subjects with treatment-related adverse events assessed

  Day 1 - Day 28

Secondary Outcomes (3)

• Time to observed Cmax (Tmax) for D-0120

  Day 1 - Day 28

• Area under the plasma concentration-time curve (AUC) for D-0120

  Day 1 - Day 28

• Maximum Observed Plasma Concentration (Cmax) of D-0120

  Day 1 - Day 28

Study Arms (2)

dose escalation in healthy subjects

EXPERIMENTAL

Drug: D-0120

dose escalation in hyperuricemia patients

EXPERIMENTAL

Drug: D-0120

Interventions

D-0120 DRUG

D-0120 monotherapy dose escalation, oral, multiple dose for up to 28 days

dose escalation in healthy subjects; dose escalation in hyperuricemia patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old and ≤ 65 years old;
• Phase Ib: fasting sUA in the morning of screening period (fasted after 8:00 pm on the previous day) of healthy subjects meets the following requirement: 270 umol/l (4.5 mg/dL) ≤ sUA \<420 umol/l (7 mg/dL)
• Phase IIa: hyperuricemia subjects should meet any of the following:
• Subject's BMI range is 18.0\~32.0 kg/m2 (inclusive);
• Female subjects must be non-pregnant and non-lactating, surgically sterilized or ≥ 60 years old. Male subjects must be surgically sterilized or agree to practice sexual abstinence;
• Results of routine blood tests, blood biochemical tests and routine urine tests are within the normal range or clinically insignificant as judged by the principle investigator. Routine urine tests include normal urine creatinine, urine protein/creatinine ratio. ECGs are within the normal range or clinically insignificant as judged by the principle investigator.
• Subjects have the ability to follow study and follow-up procedures.
• Subjects have the ability to understand the study protocol and the risks involved, and must provide signed informed consent form to participate in the study.

You may not qualify if:

• History of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, nervous, hepatic, renal, urinary, gastrointestinal, immune, endocrine, psychiatric diseases, or clinical abnormalities that may pose excessive risks to the subjects or affect outcome or study interpretation at the discretion of the investigators;
• Allergic constitution, or allergy to any drug used in the study or any ingredient of study drug;
• History of malignant tumors;
• Subjects with positive results of any of the following items: screening hepatitis C antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg) and treponema pallidum (only for phase Ib healthy subjects);
• Urinary calculi confirmed by B-ultrasound during screening period;
• Myocardial infarction, angina pectoris, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack within 3 months prior to screening;
• Participation in clinical studies of any investigational drugs or medical devices within 3 months prior to screening;
• Major surgery within 3 months prior to randomization;
• Any clinically significant acute diseases within one month prior to screening at the discretion of the investigators;
• Gout flare within 14 days prior to randomization;
• Use of other uric acid-lowering drugs (allopurinol, febuxostat, probenecid, benzbromarone) within 14 days prior to randomization;
• Daily dose of aspirin \> 100 mg within 14 days before randomization;
• Use of any diuretic within 14 days before randomization;
• Use of any Chinese herbal medicine within 14 days before randomization;
• History of drug abuse or alcohol abuse (for phase Ib healthy subjects, the screening alcohol test and urine drug test are positive);

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (6)

Site 04

Bengbu, Anhui, China

Location

Site 03

Nanjing, Jiangsu, China

Location

Site 07

Nanjing, Jiangsu, China

Location

Site 01- The second affiliated hospital of zhejiang university school of medicine

Hangzhou, Zhejiang, China

Location

Site 06

Huzhou, Zhejiang, China

Location

Site 05

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Hyperuricemia; Gout

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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 Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 23, 2019
• Study Start: April 18, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

CN (6)