Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment

Phase 1

Completed

• Conditions: Renal Impairment
• Interventions: Drug: IBI362

• Registration Number: NCT05793450
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

The purpose of this study is to assess how fast IBI362 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-03-31
• Study Start: 2023-05-05
• Primary Completion: 2023-09-18
• Study Completion: 2023-11-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-18
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• All Participants:

  o The weight of male subjects is not less than 50 kg, and the body weight of female subjects is not less than 45 kg, and the body mass index (BMI) is within the range of 20~30 kilograms per meter squared (kg/m²), inclusive, at screening

• Healthy Participants:

  -- Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function, assessed by estimated glomerular filtration rate (eGFR) ≥90 milliliters per minute (mL/min) at screening

• Participants with Renal Impairment:

  • Males or females with stable mild to severe renal impairment, assessed by eGFR

Exclusion Criteria

• All Participants:

  • Pregnant or lactating women, or men or women who are of childbearing potential and are not willing to use contraception within 6 months from the screening period to the administration of the study drug
  • Have known allergies to IBI362 or related compounds
  • Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
  • Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5× the upper limit of normal (ULN) or total bilirubin (TBL) >1× ULN
  • Severe gastrointestinal diseases (such as active ulcer, pyloric obstruction, inflammatory bowel disease, etc.) occurred within 6 months before screening, or received gastrointestinal surgery or long-term use of drugs that directly affect gastrointestinal motility due to chronic gastrointestinal diseases
  • Have a history of acute and chronic pancreatitis, or serum amylase and/or lipase ≥ 1.5× ULN at screening, or fasting Triglyceride ≥ 5.64 mmol/L (500 mg/dl)

• Participants with Renal Impairment:

  • obstructive urinary tract diseases (such as urinary stones, urinary tract obstruction caused by abdominal space-occupying lesions, etc.) or renal dysfunction caused by special types of renal parenchymal damage (such as polycystic kidney, medullary sponge kidney, Renal tumors, etc.) and/or patients with renal impairment who have diseases that are not related to renal disease but can cause renal impairment (eg, renal artery stenosis, acute drug injury, severe infection, hypovolemia, heart failure, etc.).
  • Have a history of kidney transplant
  • The treatment medication and/or the treatment medication of other comorbid diseases have been taken stably for less than 1 month at screening, or there are new medications within 1 month before screening (except temporary or intermittent use of drugs, such as Erythropoietin once a month, or diuretics as needed, etc.), or received any drug known to alter renal tubular creatinine secretion within 14 days or 5 half-lives before screening, such as cimetidine D, trimethoprim or cibenzoline, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBI362 - Mild and Moderate Renal Impairment	IBI362	Group 2 - IBI362 administered SC to participants with mild and moderate renal impairment.
IBI362 - Healthy	IBI362	Group 1 - IBI362 administered subcutaneously (SC) to healthy participants with normal renal function.
IBI362 - Severe Renal Impairment	IBI362	Group 3 - IBI362 administered SC to participants with severe renal impairment.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI362	Predose through 1344 hours postdose
PK: Area Under the Concentration Versus Time Curve (AUC) of IBI362	Predose through 1344 hours postdose

Trial Locations

Locations (1)

Aerospace Center Hospital; 🇨🇳 Beijing, Beijing, China