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OpenTrials
Completed

NCT Number: NCT06277752

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

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator

Treatment and study plan

dose-5 group

Drug

IBI128 300mg po. QD(Quaque Die)

dose-1 group

Drug

IBI128 25mg po. QD(Quaque Die)

dose-2 group

Drug

IBI128 50mg po. QD(Quaque Die)

dose-4 group

Drug

IBI128 200mg po. QD(Quaque Die)

dose-3 group

Drug

IBI128 100mg po. QD(Quaque Die)

Primary outcomes

  1. PK parameter: Cmax

    Time frame: Up to Day 8

    Maximum plasma concentration(Cmax) of IBI128

  2. PK parameter: AUC

    Time frame: Up to Day 8

    Area under the concentration-time curve (AUC)of IBI128

  3. PK parameter: Tmax

    Time frame: Up to Day 8

    Time to ahieve Cmax

  4. PK parameter: T1/2

    Time frame: 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 outcomes

  1. Safety parameter: AE

    Time frame: Up to Day 8

    Number of subjects with Adverse Event

  2. PD parameter: serum UA (uric acid)

    Time frame: Up to Day 8

    The Percentage change of serum UA assesed by Area Under Curve 24,Cmean,24,Cmean,24 of IBI128 from baseline.

  3. Tolerability parameter: SAE

    Time frame: Up to Day 8

    Number of subjects with Serious Adverse Event

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
Mar 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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