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Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment

Primary Purpose

Renal Impairment

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IBI362
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Renal Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Aerospace Center HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

IBI362 - Mild and Moderate Renal Impairment

IBI362 - Healthy

IBI362 - Severe Renal Impairment

Arm Description

Group 2 - IBI362 administered SC to participants with mild and moderate renal impairment.

Group 1 - IBI362 administered subcutaneously (SC) to healthy participants with normal renal function.

Group 3 - IBI362 administered SC to participants with severe renal impairment.

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI362
PK: Area Under the Concentration Versus Time Curve (AUC) of IBI362

Secondary Outcome Measures

Full Information

First Posted
March 20, 2023
Last Updated
May 18, 2023
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05793450
Brief Title
Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment
Official Title
Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
October 13, 2023 (Anticipated)
Study Completion Date
October 13, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IBI362 - Mild and Moderate Renal Impairment
Arm Type
Experimental
Arm Description
Group 2 - IBI362 administered SC to participants with mild and moderate renal impairment.
Arm Title
IBI362 - Healthy
Arm Type
Experimental
Arm Description
Group 1 - IBI362 administered subcutaneously (SC) to healthy participants with normal renal function.
Arm Title
IBI362 - Severe Renal Impairment
Arm Type
Experimental
Arm Description
Group 3 - IBI362 administered SC to participants with severe renal impairment.
Intervention Type
Drug
Intervention Name(s)
IBI362
Intervention Description
2.0mg, SC, single dose
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI362
Time Frame
Predose through 1344 hours postdose
Title
PK: Area Under the Concentration Versus Time Curve (AUC) of IBI362
Time Frame
Predose through 1344 hours postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Yu
Phone
0512-69566088
Email
yang.yu@innoventbio.com
Facility Information:
Facility Name
Aerospace Center Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100049
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Wang
Phone
010-59971772
Email
wjlsq@sina.com

12. IPD Sharing Statement

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Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment

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