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

NCT07375758 | Recruiting Phase 1

• 1 other identifier: MIL116-CT101
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immunoglobulin A Nephropathy

Keywords

Anti-APRIL monoclonal antibody; MIL116; IgAN; CLYM116

Outcome Measures

Primary Outcomes (4)

• 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.

  up to 6 months after enrollment

• 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.

  up to 18 months after enrollment

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

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

  up to 18 months after enrollment

• Change in 24-Hour Urine UPCR from Baseline at Week 24

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

  up to 18 months after enrollment

Study Arms (2)

MIL116

EXPERIMENTAL

Drug: MIL116

Placebo

PLACEBO COMPARATOR

Drug: Matching Placebo

Interventions

MIL116 DRUG

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

MIL116

Matching Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Beijing Mabworks Biotech Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Hong Zhang, Doctor

CONTACT

(+86)010-83572388; hongzh@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 29, 2026
• Study Start: February 5, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-01

Locations

CN (1)