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Safety and Tolerability, and PK of Sibeprenlimab in Chinese Healthy Subject | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Randomized, Open-label, Phase 1 Trial to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Sibeprenlimab Solution Administered Subcutaneously in Chinese Healthy Subjects

NCT07105124•Otsuka Beijing Research Institute

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Chinese subject between 18 and 55 years of age, inclusive, at the screening visit.
•Healthy, as determined by pretrial medical evaluation (medical history, physical examination, vital signs, 12-lead electrocardiogram \[ECG\], and clinical aboratory evaluations), as judged by the investigator.
•Body mass index between 19 and 32 kg/m2, inclusive, and body weight not less than 50 kg at the screening visit.
•Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
•Screening clinical laboratory test values for IgA, IgG, and IgM must meet the following criteria (the clinical laboratory tests may be repeated once per the discretion of the investigator):
•* Serum IgA: ≥ 0.8 g/L
•* Serum IgG: ≥ 7.0 g/L
•* Serum IgM: ≥ 0.4 g/L

Exclusion Criteria

•Subjects with potential to contribute to pregnancy who do not agree to practice 2 different approved methods of birth control or remain fully abstinent (periodic abstinence \[eg, calendar, ovulation, symptothermal, post ovulation methods\] or withdrawal are not acceptable methods of contraception) from the time of consent through the end of the subject's participation in the trial and an additional 90 days (biological male subjects) or 30 days (biological female subjects) thereafter. If employing birth control, 2 of the following methods must be used: vasectomy, tubal ligation, intrauterine device, birth control pill, birth control implant, birth control depot injection, birth control patch, condom with spermicide, sponge with spermicide, or occlusive cap (vaginal diaphragm or cervical/vault cap) with spermicide.
•Subjects must also agree not to donate sperm from the time of consent through the end of the subject's participation in the trial and an additional 90 days thereafter.
•Subject has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, blood dyscrasias or other medical disorder, including psychiatric disorders, cirrhosis, or malignancy. History of minor skin cancers (not including melanoma) or surgically treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary.
•History of a previous severe allergic reaction with generalized urticaria; angioedema or anaphylaxis.
•Known hypoglobulinemia disorder (ie, common variable immunodeficiency), X-linked agammaglobulinemia, selective IgA deficiency, selective IgM deficiency).
•History of chronic infection (eg, tuberculosis, osteomyelitis, etc) or any infection requiring hospitalization or treatment with antivirals, antibiotics, or antifungal therapy within 30 days prior to administration of IMP.
•Received vaccination during the 30 days prior to administration of IMP.
•Known hepatic (ie, prior or chronic hepatitis C or hepatitis B infection, nonalcoholic steatohepatitis, or cirrhosis) or biliary abnormalities (Gilberts syndrome or asymptomatic gallstones are permitted exceptions).
•A QT interval corrected for heart rate using Fridericia's correction (QTcF) \> 450 msec for biological male subjects or \> 470 msec for biological female subjects (may be repeated once).
•Previous receipt of antibody or biologic therapy whether licensed or investigational (Ig products, monoclonal antibodies, or antibody fragments) within 30 days prior to dosing or 5 half-lives within the dose of IMP, whichever is longer.
+10 more criteria

Locations (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

October 18, 2022

Primary Completion Date

February 15, 2023

Completion Date

February 15, 2023

Last Updated

August 5, 2025

Enrollment

ACTUAL participants

Conditions

Healthy Subjects (HS)

Interventions

Sibeprenlimab

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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