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

Innovent Biologics

Status and phase: Completed; Phase 1

Conditions: Gout Arthritis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06277752

CIBI128A101

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

IBI128

Experimental group

Description:

IBI128 po. QD(Quaque Die)

Treatment:

Drug: dose-3 group

Drug: dose-2 group

Drug: dose-4 group

Drug: dose-1 group

Drug: dose-5 group