Clinical trial NCT06277752: A Study to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128(A New Xanthine Oxidase Inhibitor)
Official title: A Randomized, Open-label,Single Dosing Clinical Trail to Investigate the Pharmacokinetic/Pharmacodynamic Characteristics of IBI128 in Chinese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout Arthritis
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: PK parameter: Cmax
timeFrame: Up to Day 8
measure: PK parameter: AUC
timeFrame: Up to Day 8
measure: PK parameter: Tmax
timeFrame: Up to Day 8
measure: PK parameter: T1/2
timeFrame: Up to Day 8
Secondary outcomes:
measure: Safety parameter: AE
timeFrame: Up to Day 8
measure: PD parameter: serum UA (uric acid）
timeFrame: Up to Day 8
measure: Tolerability parameter: SAE
timeFrame: Up to Day 8
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated
state: Henan
Study officials:
References: