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

NCT ID: NCT06277752

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2024-03-16

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IBI128

IBI128 po. QD(Quaque Die)

Group Type: EXPERIMENTAL

dose-5 group

Intervention Type: DRUG

IBI128 300mg po. QD(Quaque Die)

dose-1 group

Intervention Type: DRUG

IBI128 25mg po. QD(Quaque Die)

dose-2 group

Intervention Type: DRUG

IBI128 50mg po. QD(Quaque Die)

dose-4 group

Intervention Type: DRUG

IBI128 200mg po. QD(Quaque Die)

dose-3 group

Intervention Type: DRUG

IBI128 100mg po. QD(Quaque Die)

Interventions

dose-5 group

IBI128 300mg po. QD(Quaque Die)

Intervention Type: DRUG

dose-1 group

IBI128 25mg po. QD(Quaque Die)

Intervention Type: DRUG

dose-2 group

IBI128 50mg po. QD(Quaque Die)

Intervention Type: DRUG

dose-4 group

IBI128 200mg po. QD(Quaque Die)

Intervention Type: DRUG

dose-3 group

IBI128 100mg po. QD(Quaque Die)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male subjects between the ages of 18 and 50 years at screening;

2. 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)

3. Participants who are overtly healthy as determined by medical evaluation including medical history, laboratory tests, vital signs and standard 12 lead ECGs.

4. Subject is willing to participate and to Sign written informed consent form.

Exclusion Criteria

1. Subjects with a history of hypersensitivities to investigational products, including drug allergies (caused by aspirin, antibiotics, etc.), or a history of clinically significant hypersensitivities

2. 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

3. 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.

4. Subjects with a history or current have mental disease.

5. Subjects who have taken any medicine that may affect outcomes within 30 days before the first administration of the investigational product.

6. Subject who have taken IBI128 in other studies.

7. Subjects who have a history of acute arthiritis.

8. Pregnant women or breast-feeding women or men and women who has possibility of pregnancy.

9. Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated

Zhengzhou, Henan, China

Countries

China

Other Identifiers

CIBI128A101

Identifier Type: -

Identifier Source: org_study_id