Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT05793450
Phase
PHASE1
Status
Completed

Conditions

  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • IBI362 — DRUG
    2.0mg, SC, single dose

Study Details

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.

Key Dates

First listed
Mar 31, 2023
Start date
May 5, 2023
Status verified
Feb 2024
Primary completion
Sep 18, 2023
Completion
Nov 17, 2023

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

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

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI362 [ Time Frame: Predose through 1344 hours postdose ]

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