A Study to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128(A New Xanthine Oxidase Inhibitor)

NCT06277752 | Completed Phase 1

• 1 other identifier: CIBI128A101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I study to evaluate the pharmacokinetic/pharmacodynamic characteristics,safety and tolerability of IBI128 after multidosing in Chinese health subjects.

Conditions

Gout Arthritis

Outcome Measures

Primary Outcomes (4)

• PK parameter: Cmax

  Maximum plasma concentration(Cmax) of IBI128

  Up to Day 8

• PK parameter: AUC

  Area under the concentration-time curve （AUC）of IBI128

  Up to Day 8

• PK parameter: Tmax

  Time to ahieve Cmax

  Up to Day 8

• PK parameter: T1/2

  The time that takes for the dlimination processes to reduce the plasma concentration of the drug in the body by 50%.

  Up to Day 8

Secondary Outcomes (3)

• Safety parameter: AE

  Up to Day 8

• PD parameter: serum UA (uric acid）

  Up to Day 8

• Tolerability parameter: SAE

  Up to Day 8

Study Arms (1)

IBI128

EXPERIMENTAL

IBI128 po. QD(Quaque Die)

Drug: dose-5 group; Drug: dose-1 group; Drug: dose-2 group; Drug: dose-4 group; Drug: dose-3 group

Interventions

dose-5 group DRUG

IBI128 300mg po. QD(Quaque Die)

IBI128

dose-1 group DRUG

IBI128 25mg po. QD(Quaque Die)

IBI128

dose-2 group DRUG

IBI128 50mg po. QD(Quaque Die)

IBI128

dose-4 group DRUG

IBI128 200mg po. QD(Quaque Die)

IBI128

dose-3 group DRUG

IBI128 100mg po. QD(Quaque Die)

IBI128

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects between the ages of 18 and 50 years at screening;
• Subjects with a Body Mass Index (BMI) between 18.0 (inclusive) and 28.0 kg/m2 (inclusive); and a total body weight ≥55kg (male） and 45kg (female)
• Participants who are overtly healthy as determined by medical evaluation including medical history, laboratory tests, vital signs and standard 12 lead ECGs.
• Subject is willing to participate and to Sign written informed consent form.

You may not qualify if:

• Subjects with a history of hypersensitivities to investigational products, including drug allergies (caused by aspirin, antibiotics, etc.), or a history of clinically significant hypersensitivities
• Subjects with evidence or a history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or surgery (except simple appendectomy or repair of hernia) that may influence drug absorption
• Subjects with evidence or a history of clinically significant hepatic (including carrier of viral hepatitis), renal, neurologic, immunologic, pulmonary, endocrine, hematological, neoplastic, cardiovascular or psychiatric (mood disorder, obsessive-compulsive disorder, etc.) diseases.
• Subjects with a history or current have mental disease.
• Subjects who have taken any medicine that may affect outcomes within 30 days before the first administration of the investigational product.
• Subject who have taken IBI128 in other studies.
• Subjects who have a history of acute arthiritis.
• Pregnant women or breast-feeding women or men and women who has possibility of pregnancy.
• Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

The First Affiliated

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Arthritis, Gouty

Condition Hierarchy (Ancestors)

Gout; 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 26, 2024
• Study Start: March 5, 2024
• Primary Completion: March 16, 2024
• Study Completion: March 16, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

CN (1)