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

Gout Arthritis Clinical Trial

Official title:

A Randomized, Open-label,Single Dosing Clinical Trail to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128 in Chinese Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06277752
• Other study ID #: CIBI128A101
• Status: Completed
• Phase: Phase 1
• Start date: March 5, 2024
• Est. completion date: March 16, 2024

Study information

• Verified date: March 2024
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 16, 2024
• Est. primary completion date: March 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Gouty
• Gout Arthritis

Intervention

Drug:
• dose-5 group
IBI128 300mg po. QD(Quaque Die)
• dose-1 group
IBI128 25mg po. QD(Quaque Die)
• dose-2 group
IBI128 50mg po. QD(Quaque Die)
• dose-4 group
IBI128 200mg po. QD(Quaque Die)
• dose-3 group
IBI128 100mg po. QD(Quaque Die)

Locations

Country	Name	City	State
China	The First Affiliated	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameter: Cmax	Maximum plasma concentration(Cmax) of IBI128	Up to Day 8
Primary	PK parameter: AUC	Area under the concentration-time curve (AUC)of IBI128	Up to Day 8
Primary	PK parameter: Tmax	Time to ahieve Cmax	Up to Day 8
Primary	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	Safety parameter: AE	Number of subjects with Adverse Event	Up to Day 8
Secondary	PD parameter: serum UA (uric acid)	The Percentage change of serum UA assesed by Area Under Curve 24,Cmean,24,Cmean,24 of IBI128 from baseline.	Up to Day 8
Secondary	Tolerability parameter: SAE	Number of subjects with Serious Adverse Event	Up to Day 8