Gout Arthritis
Conditions
Brief summary
A Phase I study to evaluate the pharmacokinetic/pharmacodynamic characteristics,safety and tolerability of IBI128 after multidosing in Chinese health subjects.
Interventions
DRUGdose-5 group
IBI128 300mg po. QD(Quaque Die)
DRUGdose-1 group
IBI128 25mg po. QD(Quaque Die)
DRUGdose-2 group
IBI128 50mg po. QD(Quaque Die)
DRUGdose-4 group
IBI128 200mg po. QD(Quaque Die)
DRUGdose-3 group
IBI128 100mg po. QD(Quaque Die)
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter: Cmax | Up to Day 8 | Maximum plasma concentration(Cmax) of IBI128 |
| PK parameter: AUC | Up to Day 8 | Area under the concentration-time curve （AUC）of IBI128 |
| PK parameter: Tmax | Up to Day 8 | Time to ahieve Cmax |
| PK parameter: T1/2 | Up to Day 8 | The time that takes for the dlimination processes to reduce the plasma concentration of the drug in the body by 50%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PD parameter: serum UA (uric acid） | Up to Day 8 | The Percentage change of serum UA assesed by Area Under Curve 24，Cmean,24，Cmean,24 of IBI128 from baseline. |
| Tolerability parameter: SAE | Up to Day 8 | Number of subjects with Serious Adverse Event |
| Safety parameter: AE | Up to Day 8 | Number of subjects with Adverse Event |
Countries
China
Outcome results
None listed