CompletedPhase 1

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

China30 participantsStarted 2024-03-05

Plain-language summary

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

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy male subjects between the ages of 18 and 50 years at screening;
✓. 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)
✓. Participants who are overtly healthy as determined by medical evaluation including medical history, laboratory tests, vital signs and standard 12 lead ECGs.
✓. Subject is willing to participate and to Sign written informed consent form.

Exclusion criteria

✕. Subjects with a history of hypersensitivities to investigational products, including drug allergies (caused by aspirin, antibiotics, etc.), or a history of clinically significant hypersensitivities
✕. 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
✕. 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.
✕. Subjects with a history or current have mental disease.
✕. Subjects who have taken any medicine that may affect outcomes within 30 days before the first administration of the investigational product.
✕. Subject who have taken IBI128 in other studies.
✕. Subjects who have a history of acute arthiritis.
✕. Pregnant women or breast-feeding women or men and women who has possibility of pregnancy.

What they're measuring

PK parameter: Cmax

Timeframe: Up to Day 8

PK parameter: AUC

Timeframe: Up to Day 8

PK parameter: Tmax

Timeframe: Up to Day 8

PK parameter: T1/2

Timeframe: Up to Day 8

Trial details

NCT IDNCT06277752

SponsorInnovent Biologics (Suzhou) Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-16

View on ClinicalTrials.gov More Gout Arthritis trials

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy male subjects between the ages of 18 and 50 years at screening;
✓. 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)
✓. Participants who are overtly healthy as determined by medical evaluation including medical history, laboratory tests, vital signs and standard 12 lead ECGs.
✓. Subject is willing to participate and to Sign written informed consent form.

Exclusion criteria

✕. Subjects with a history of hypersensitivities to investigational products, including drug allergies (caused by aspirin, antibiotics, etc.), or a history of clinically significant hypersensitivities
✕. 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
✕. 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.
✕. Subjects with a history or current have mental disease.
✕. Subjects who have taken any medicine that may affect outcomes within 30 days before the first administration of the investigational product.
✕. Subject who have taken IBI128 in other studies.
✕. Subjects who have a history of acute arthiritis.
✕. Pregnant women or breast-feeding women or men and women who has possibility of pregnancy.