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Safety and Tolerability, and PK of Sibeprenlimab in Chinese Healthy Subject

NCT07105124 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-08-05

No results posted yet for this study

Summary

A Trial to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics, of Sibeprenlimab Solution Administered Subcutaneously in Chinese Healthy Subjects

Conditions

  • Healthy Subjects (HS)

Interventions

DRUG

Sibeprenlimab

Sibeprenlimab is being developed for the treatment of immunoglobulin A nephropathy (IgAN), an autoimmune glomerulonephritis characterized by the deposition of immunoglobulin (Ig) A-containing immune complexes in the kidney.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    collaborator INDUSTRY

  • Otsuka Beijing Research Institute

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-18
Primary Completion
2023-02-15
Completion
2023-02-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07105124 on ClinicalTrials.gov