IBI3034 Study in Healthy Adults and Patients With Primary IgA Nephropathy

NCT07886476 | Not Yet Recruiting Phase 1

• 1 other identifier: CIBI3034A101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Part 1 is a Single Ascending Dose (SAD) study, and Part 2 is a Multiple Ascending Dose (MAD) study

Conditions

IgA Nephropathy (IgAN)

Outcome Measures

Primary Outcomes (2)

• Safety: Incidence of adverse events (AEs) and serious adverse events (SAEs) following a single dose of IBI3034 in healthy participants(Part 1)

  through study completion,an average of 169 days

• Safety: Incidence of AEs and SAEs following multiple doses of IBI3034 in participants with primary IgA nephropathy(Part 2)

  through study completion,an average of 252 days

Secondary Outcomes (21)

• Pharmacodynamic (PD) Profile: Change from baseline in serum immunoglobulin levels(Part 1)

  through study completion,an average of 169 days

• Exploratory Clinical Profile: Change from baseline in UPCR(Part2)

  through study completion,an average of 252 days

• Pharmacodynamic (PD) Profile: Change from baseline in serum immunoglobulin levels (Part 2)

  through study completion,an average of 252 days

• Exploratory Clinical Profile: Change from baseline in UACR (Part 2)

  through study completion,an average of 252 days

• Exploratory Clinical Profile: Change from baseline in eGFR (Part 2)

  through study completion,an average of 252 days

Study Arms (3)

IBI3034 group

EXPERIMENTAL

IBI3034，SC/IV,corresponding dose regimen according to study cohort

Drug: IBI3034

Placebo Group

EXPERIMENTAL

Matching placebo of IBI3034， SC/IV ，corresponding dose regimen according to study design

Drug: Placebo

Telitacicept (Part 2 only)

EXPERIMENTAL

Telitacicept , 240 mg subcutaneous injection once weekly

Drug: Telitacicept

Interventions

Placebo DRUG

Matching placebo of IBI3034，SC/ IV ，corresponding dose regimen according to study design

Placebo Group

Telitacicept DRUG

Telitacicept 240 mg SC QW × 24 doses (Weeks 0-24).

Telitacicept (Part 2 only)

IBI3034 DRUG

IBI3034,SC/IV,corresponding dose regimen according to study design

IBI3034 group

Eligibility Criteria

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

Inclusion (Part 1 - Healthy): 1. Understand and voluntarily sign the informed consent form (ICF). 2. Male or female, aged 18 to 45 years (inclusive). 3. Body weight of 50 to 120 kg, BMI of 18.0 to 28.0 kg/m². 4. Males and females of childbearing potential must agree to use highly effective contraception and refrain from donating sperm/ova for 6 months after the last dose. Inclusion (Part 2 - IgAN) 1. Understand and voluntarily sign the informed consent form (ICF). 2. Male or female, aged 18 to 65 years (inclusive). 3. Biopsy-confirmed primary IgA nephropathy without known secondary causes within 10 years prior to screening. 4. Persistent proteinuria at screening: 24h-UPCR ≥ 0.75 g/g or 24h-UPE ≥ 1.0 g/24h. 5. eGFR ≥ 45 mL/min/1.73 m² at screening (CKD-EPI 2021 equation). 6. Receiving stable and optimized supportive therapy (ACEI and/or ARB ≥ 12 weeks, stable dose ≥ 4 weeks prior to randomization). 7. Participants of childbearing potential must agree to use highly effective contraception and refrain from donating sperm/ova for 6 months after the last dose. Exclusion (Both Parts) * 1\. Known hypersensitivity to any component of IBI3034 or history of severe allergic reactions. 2\. Inability to tolerate subcutaneous injections. 3. Vaccination with a live vaccine within 30 days prior to randomization. 4. Blood donation or blood loss ≥ 400 mL within 3 months prior to screening. 5. Positive serological test for HIV-Ab, Treponema pallidum antibody, HCV-Ab, or any HBV-related markers. 6\. History of disseminated herpes zoster or recurrent localized dermatomal herpes zoster. 7\. Known active tuberculosis or positive IGRA. 8. Concurrent malignancy or lymphoproliferative disease. 9. Immunodeficiency disorders. 10. Severe infection or surgery requiring hospitalization within 6 months prior to randomization. 11\. Pregnant or lactating females. 12. History of drug abuse within 12 months prior to screening. 13. Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study. Part 2 Specific Exclusions 1. Participation in another drug or medical device clinical trial within 90 days prior to randomization. 2. Systemic corticosteroids (\>10 mg/day for \>14 consecutive days) or immunosuppressive therapy within 12 weeks prior to randomization. 3. Use of renin inhibitors or medications significantly affecting creatinine levels within 4 weeks prior to randomization. 4. Prior use of APRIL monoclonal antibodies, BAFF monoclonal antibodies, BAFF/APRIL dual-targeting agents, TACI/BCMA-targeting agents, etc. 5. Concurrent nephrotic syndrome or hypoalbuminemia. 6. Concurrent other chronic kidney diseases (e.g., diabetic nephropathy, membranous nephropathy). 7. Rapidly progressive glomerulonephritis. 8. Known or suspected immunodeficiency disorders. 9. Poorly controlled blood pressure prior to randomization (systolic BP \> 140 mmHg or diastolic BP \> 90 mmHg). 10. Poorly controlled type 2 diabetes mellitus (HbA1c \> 8%). 11. History of bone marrow, hematopoietic stem cell, or solid organ transplantation. 12. Laboratory abnormalities during screening, such as ALT/AST \> 3.0 × ULN, TBIL \> 1.5 × ULN, etc. 13. Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100009, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

telitacicept

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

Yating Liu

CONTACT

0512-69566088; yangting.liu@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 21, 2026
• Study Start: October 15, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

CN (1)