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

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

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

Study Overview

• Status: Completed
• Conditions: Gout Arthritis
• Intervention / Treatment: Drug: dose-5 group; Drug: dose-1 group; Drug: dose-2 group; Drug: dose-4 group; Drug: dose-3 group

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • The First Affiliated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI128; IBI128 po. QD(Quaque Die)	Drug: dose-5 group; IBI128 300mg po. QD(Quaque Die); Drug: dose-1 group; IBI128 25mg po. QD(Quaque Die); Drug: dose-2 group; IBI128 50mg po. QD(Quaque Die); Drug: dose-4 group; IBI128 200mg po. QD(Quaque Die); Drug: dose-3 group; IBI128 100mg po. QD(Quaque Die)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety parameter: AE	Number of subjects with Adverse Event	Up to Day 8
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
Tolerability parameter: SAE	Number of subjects with Serious Adverse Event	Up to Day 8

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Actual): March 16, 2024
• Study Completion (Actual): March 16, 2024

Study Registration Dates

• First Submitted: February 4, 2024
• First Submitted That Met QC Criteria: February 19, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Arthritis, Gouty
• Other Study ID Numbers: CIBI128A101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No