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Immunoglobulin A NephropathyPhase 1/2NCT07375758

A Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy.

A Phase 1/2 study testing MIL116 in people with Immunoglobulin A Nephropathy, run by Beijing Mabworks Biotech Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a Phase I/II study designed to evaluate the safety, tolerability, PK and PD of subcutaneous MIL116, an anti-APRIL monoclonal antibody, in healthy participants and patients with IgA Nephropathy. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Immunoglobulin A Nephropathy
What is being tested?
MIL116
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
130 participants
Where
1 siteChina
Study dates
5 Feb 2026to Jun 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • -
  • Phase Ia:
  • Able to understand and voluntarily sign the written Informed Consent Form (ICF), willing and able to comply with all study requirements;
  • Healthy participants aged 18 to 55 years (inclusive) at the time of signing the ICF, of either sex;
  • Have a body mass index (BMI) between 19 to 32 kg/m² (inclusive) and a body weight ≥ 50 kg at screening;
  • Assessed to be in good health status based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests, with no clinically significant abnormalities;
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  • Have a total immunoglobulin G (IgG) level > 10 g/L at screening; and immunoglobulin A (IgA) and immunoglobulin M (IgM) levels within the normal reference ranges.
  • Phase Ib\&II:
  • Able to understand and voluntarily sign the written ICF, and willing and able to comply with all study requirements;
  • Aged ≥ 18 years at the time of signing the ICF, of either sex, with a BMI ≥ 16 kg/m²;
  • Biopsy-confirmed diagnosis of IgA Nephropathy (IgAN). Participants must have a 24-hour urine protein-to-creatinine ratio (UPCR) ≥ 0.5 g/g or 24-hour urine protein ≥ 0.75 g prior to the first dose;
  • Have been receiving an optimized and stable dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor antagonist (ARB). If currently receiving sodium-glucose cotransporter 2 inhibitors (SGLT2i) and / or endothelin receptor antagonists (ERA), the same administration and dose stability requirements apply for;
  • Have acceptable hematologic, hepatic, coagulation, and renal function as assessed by clinical laboratory tests.

Who cannot join

  • -
  • Phase Ia:
  • Nursing, lactating or pregnant, or who have plans to become pregnant during the study
  • History or evidence of any clinically significant disease, disorder, or condition that, in the investigator's judgment, may pose a risk to the participants' safety, interfere with the study assessments, or render the subject unsuitable for participation, including but not limited to respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurologic, cardiovascular, psychiatric, or other systemic diseases;
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition, including human immunodeficiency virus (HIV) infection or asplenia; history of recurrent or severe infections, or long-term use of immunosuppressive agents within 6 months prior to screening;
  • History of chronic infection (e.g., tuberculosis, osteomyelitis) or any infectious disease requiring hospitalization or treatment with antiviral, antibiotic, or antifungal agents within 28 days prior to administration of the study drug;
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  • Use of any prescription medications, over-the-counter (OTC) drugs, herbal products, topical products, or dietary supplements within 28 days prior to administration of the study drug or for within 5 half-lives of the drug (whichever is longer);
  • Participation in any clinical study of an investigational drug or medical device, or receipt of any investigational study drug, within 3 months prior to administration of the study drug or within 5 half-lives (whichever is longer);
  • Receipt of any marketed or investigational antibody or biologic therapy (including immunoglobulin products, monoclonal antibodies, or antibody fragments) within 28 days prior to administration of the study drug or within 5 half-lives (whichever is longer);
  • History of drug abuse or substance dependence, or a positive urine drug abuse screening result during the screening period.
  • Phase Ib\&II:
  • Secondary IgAN or IgA vasculitis (Henoch-Schönlein purpura), as diagnosed by the investigator;
  • Presence of chronic kidney disease of causes other than IgAN;
  • Other significant pathological abnormalities identified on kidney biopsy;
  • Kidney biopsy demonstrating tubular-interstitial fibrosis > 50% or glomerular crescents involving > 25% of glomeruli. Note: The most recent kidney biopsy will be prioritized for eligibility assessment;
  • Clinical suspicion of rapidly progressive glomerulonephritis based on an estimated glomerular filtration rate (eGFR) decline ≥ 50% within 3 months prior to the screening visit;
  • Nephrotic syndrome, defined as 24-hour urine protein > 3.5 g accompanied by hypoalbuminemia (serum albumin < 30 g/L). Subjects with isolated nephrotic-range proteinuria (> 3.5 g/d) are excluded;
  • Receipt of rituximab or any B-cell depleting agent within 6 months prior to screening. Participants with CD4+ T-cell count < 200 cells/μL are excluded;
  • Total IgG level < 6 g/L at screening; uncontrolled type 2 diabetes mellitus, defined as glycated hemoglobin (HbA1c) > 8%; or diagnosis of type 1 diabetes mellitus;
  • History of prior treatment with any APRIL-targeted medication;
  • Receipt of biologic agents, such as belimumab or eculizumab, within 3 months prior to the first dose of the study drug;
  • Receipt of cyclophosphamide within 3 months prior to the first dose; use of other immunosuppressive agents within 28 days prior to the first dose, including but not limited to azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, methotrexate, or tripterygium wilfordii; systemic corticosteroids used at an average daily dose equivalent to ≥40 mg prednisone for more than 14 days within 28 days prior to the screening visit, or use of oral delayed-release budesonide capsules within 1 year prior to the screening visit.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hong Zhang, Doctor contact

(+86)010-83572388

hongzh@bjmu.edu.cn

China1 site, 1 recruiting

  • Peking University First Hospital

    Beijing

    Hong Zhang, (+86)010-83572388, hongzh@bjmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase I/II, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MIL116 in Healthy Participants and Patients With IgA Nephropathy

This is a Phase I/II study designed to evaluate the safety, tolerability, PK and PD of subcutaneous MIL116, an anti-APRIL monoclonal antibody, in healthy participants and patients with IgA Nephropathy.

Being tested
MIL116, Matching Placebo
Keywords
Anti-APRIL monoclonal antibody, MIL116, IgAN, CLYM116
Medical subject headings
Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MIL116Drug

    MIL116 is supplied as sterile solution for subcutaneous (SC) injection.

  • Matching PlaceboDrug

    Placebo is to be administered at a matching volume by SC injection.

Study groups in NCT07375758
Study groupRoleWhat they receive
MIL116ExperimentalNot described
Receives: Drug: MIL116
PlaceboPlacebo comparatorNot described
Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase Ia: Safety and Tolerability of Single Ascending Doses of MIL116 in Healthy Participants.

    Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.

    Measured: up to 6 months after enrollment

  2. Phase Ib: Safety and Tolerability of Multiple-Ascending Doses of MIL116 in IgAN Participants.

    Description: Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.

    Measured: up to 18 months after enrollment

  3. Phase II: Change in Gd-IgA1 from Baseline at Week 12

    Evaluate the degree and percentage change of Gd-IgA1 from baseline.

    Measured: up to 18 months after enrollment

  4. Change in 24-Hour Urine UPCR from Baseline at Week 24

    Evaluate the degree and percentage change of 24-hour urine UPCR from baseline

    Measured: up to 18 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2026
  2. Study start5 Feb 2026
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07375758
Sponsor's protocol ID
MIL116-CT101
Status last verified
Jan 2026
First submitted
22 Jan 2026
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MIL116 in people with Immunoglobulin A Nephropathy, run by Beijing Mabworks Biotech Co., Ltd. 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 13 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hong Zhang, Doctor ((+86)010-83572388, hongzh@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ia: Safety and Tolerability of Single Ascending Doses of MIL116 in Healthy Participants. (time frame: up to 6 months after enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07375758.

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 13 Apr 2026.

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