Healthy Subjects (HS)Phase 1NCT07105124
Safety and Tolerability, and PK of Sibeprenlimab in Chinese Healthy Subject
A Phase 1 study testing Sibeprenlimab in people with Healthy Subjects (HS), run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
A Trial to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics, of Sibeprenlimab Solution Administered Subcutaneously in Chinese Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects (HS)
- What is being tested?
- Sibeprenlimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2022to 15 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
- Concomitant use of marketed or investigational system is immunosuppressive or immunomodulatory medications (eg, corticosteroids, methotrexate, azathioprine, etc. and/or biologics) is prohibited and require a washout period prior to screening (30 days or 5 half-lives, whichever is longer).
- Has received any prescription or nonprescription (over-the-counter [OTC]) medication during the last 30 days or 5 half-lives (of the drug in question), whichever is longer, preceding baseline (Day -1), with the exception of acetaminophen, ibuprofen (or an equivalent nonsteroidal anti-inflammatory drug), hormonal contraceptives, topical medications, vitamins, minerals, traditional Chinese medicines, and dietary or herbal remedies.
- Is participating in another clinical trial of any investigational drug, device, or intervention or has received any investigational medication during the last 3 months or 5 half-lives, whichever is longer, prior to the start of screening.
- History of or current hepatitis or acquired immunodeficiency syndrome or carriers of hepatitis B surface antigen, hepatitis C antibodies, and/or human immunodeficiency virus (HIV) antibodies.
- Subject with a positive drug or alcohol screen test result at screening or Day -1. The drug screen may be repeated once per the discretion of the investigator. The drug screen also screens for cannabinoids, methylenedioxymethamphetamine, and propoxyphene. If a subject tests positive on these tests, inclusion of that subject into the trial will be based on the investigator's judgment with consultation, as needed, with the medical monitor and the sponsor.
- Subject who has a history of alcohol or drug/chemical abuse.
- Subject who has donated > 500 mL or blood within 3 months prior to the start of screening.
- Subject who has donated any plasma within 7 days prior to baseline (Day -1).
- Is an employee of the clinical research team (any sponsor or trial site employee), or has a family member who is an employee of these organizations.
- Subject is judged by the investigator or the medical monitor to be inappropriate for the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
A Trial to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics, of Sibeprenlimab Solution Administered Subcutaneously in Chinese Healthy Subjects
- Conditions
- Healthy Subjects (HS)
- Being tested
- Sibeprenlimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SibeprenlimabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 200mg Sibeprenlimab | Experimental | 200 mg Sibeprenlimab (1 × 1 mL injection) Receives: Drug: Sibeprenlimab |
| 400mg Sibeprenlimab | Experimental | 400 mg Sibeprenlimab (1 × 2 mL injection) Receives: Drug: Sibeprenlimab |
| 600 mg Sibenlimab | Experimental | 600 mg Sibenlimab (1 × 1 mL injection and 1 × 2 mL injection) Receives: Drug: Sibeprenlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sibeprenlimab serum concentrations
Sibeprenlimab serum concentrations will be listed for each subject. Summary statistics of sibeprenlimab serum concentrations will be presented by dose level. Individual and mean sibeprenlimab concentration-time profiles will be plotted for each dose level in both linear and logarithmic scales.
The following PK parameters for sibeprenlimab will be determined, as appropriate:
Cmax AUC0-t AUC0-inf tmax t1/2,z CL/F
Measured: Day 1 (predose, 4 hours postdose, and 8 hours postdose) and on Day 2 (24 hours postdose). All subjects will also have blood samples collected for PK analysis on Days 3, 5, 7, 9, 14 (Week 2), 28 (Week 4), 42 (Week 6), 56 (Week 8), 70 (Week 10), and 84
Secondary outcomes (1)
total serum IgA
To characterize the effect of sibeprenlimab on total IgA
Measured: from 1st dose to day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start18 Oct 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105124
- Sponsor's protocol ID
- 417-201-00005
- Status last verified
- Jul 2025
- First submitted
- 24 Apr 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07105124
- Acronym / sponsor ID
- 417-201-00005
- Conditions
- Healthy Subjects (HS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Trial to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics, of Sibeprenlimab Solution Administered Subcutaneously in Chinese Healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200mg Sibeprenlimab | Experimental | Drug: Sibeprenlimab200 mg Sibeprenlimab (1 × 1 mL injection) |
| 400mg Sibeprenlimab | Experimental | Drug: Sibeprenlimab400 mg Sibeprenlimab (1 × 2 mL injection) |
| 600 mg Sibenlimab | Experimental | Drug: Sibeprenlimab600 mg Sibenlimab (1 × 1 mL injection and 1 × 2 mL injection) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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):
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SibeprenlimabSibeprenlimab 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. | Drug | 200mg Sibeprenlimab, 400mg Sibeprenlimab, 600 mg Sibenlimab |
Primary outcome
Sibeprenlimab serum concentrations
Time frame: Day 1 (predose, 4 hours postdose, and 8 hours postdose) and on Day 2 (24 hours postdose). All subjects will also have blood samples collected for PK analysis on Days 3, 5, 7, 9, 14 (Week 2), 28 (Week 4), 42 (Week 6), 56 (Week 8), 70 (Week 10), and 84
Sibeprenlimab serum concentrations will be listed for each subject. Summary statistics of sibeprenlimab serum concentrations will be presented by dose level. Individual and mean sibeprenlimab concentration-time profiles will be plotted for each dose level in both linear and logarithmic scales. The following PK parameters for sibeprenlimab will be determined, as appropriate: Cmax AUC0-t AUC0-inf tmax t1/2,z CL/F
1 secondary outcome
total serum IgA
Time frame: from 1st dose to day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sibeprenlimab in people with Healthy Subjects (HS), run by Otsuka Beijing Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sibeprenlimab serum concentrations (time frame: Day 1 (predose, 4 hours postdose, and 8 hours postdose) and on Day 2 (24 hours postdose). All subjects will also have blood samples collected for PK analysis on Days 3, 5, 7, 9, 14 (Week 2), 28 (Week 4), 42 (Week 6), 56 (Week 8), 70 (Week 10), and 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.