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Not yet recruitingNCT07886476Updated Oct 21, 2026

IBI3034 Study in Healthy Adults and Patients With Primary IgA Nephropathy

A Phase 1 interventional study of IBI3034 and Placebo in IgA Nephropathy (IgAN), sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. (part of Innovent Biologics, Inc.) · Phase 1, Interventional, and Treatment

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description

A double-blind design is applied to the IBI3034 and placebo groups in both Part 1 and Part 2; the Telitacicept positive control group is open-label Part 1: A randomized, double-blind, single-center, single-dose, dose-escalation, placebo-controlled study. Healthy participants will be randomized to receive IBI3034 or placebo in a 3:1 ratio. Part 2: A randomized, double-blind, multiple-dose, dose-escalation, placebo-controlled study. Participants will be randomized in an 8:2:2 ratio to receive IBI3034, placebo, or Telitacicept.

02

Conditions studied

  • IgA Nephropathy (IgAN)
03

In context

Glomerulonephritis, IGA

262 studies on the registry are indexed under Glomerulonephritis, IGA; 102 are open to participants now.

This study's planned enrollment of 100 is above the median of 68 across 212 interventional studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 197 studies on the registry; 46 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Browse Innovent Biologics (Suzhou) Co. Ltd. studies →All Innovent Biologics, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    IBI3034 group

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

    Drug: IBI3034

  • Experimental
    Placebo Group

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

    Drug: Placebo

  • Experimental
    Telitacicept (Part 2 only)

    Telitacicept , 240 mg subcutaneous injection once weekly

    Drug: Telitacicept

Interventions

  • DrugIBI3034

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

  • DrugPlacebo

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

  • DrugTelitacicept

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

06

What researchers measure

Primary outcomes

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

    Time frame: through study completion,an average of 169 days

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

    Time frame: through study completion,an average of 252 days

Secondary outcomes

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

    Time frame: through study completion,an average of 169 days

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

    Time frame: through study completion,an average of 252 days

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

    Time frame: through study completion,an average of 252 days

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

    Time frame: through study completion,an average of 252 days

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

    Time frame: through study completion,an average of 252 days

  6. Exploratory Clinical Profile: Change from baseline in hematuria(Part2)

    Time frame: through study completion,an average of 252 days

  7. Exploratory Clinical Profile: Change from baseline in serum albumin(Part2)

    Time frame: through study completion,an average of 252 days

  8. Exploratory Clinical Profile: Change from baseline in serum creatinine(Part2)

    Time frame: through study completion,an average of 252 days

  9. Exploratory Clinical Profile: Change from baseline in blood pressure (both systolic and diastolic)(Part2)

    Time frame: through study completion,an average of 252 days

  10. Maximum Concentration, Cmax (Part 1)

    Time frame: through study completion,an average of 57 days

  11. Time to Reach Peak Plasma Concentration (Tmax)(Part 1)

    Time frame: through study completion,an average of 57 days

  12. Apparent Clearance (CL/F) (Part 1)

    Time frame: through study completion,an average of 57 days

  13. Apparent Volume of Distribution (Vz/F) (Part 1)

    Time frame: through study completion,an average of 57 days

  14. Terminal Half-Life (T1/2) (Part 1)

    Time frame: through study completion,an average of 57 days

  15. Area Under the Concentration-Time Curve, AUC (Part 1)

    Time frame: through study completion,an average of 57 days

  16. Maximum Concentration, Cmax (Part 2)

    Time frame: through study completion,an average of 156 days

  17. Time to Reach Peak Plasma Concentration (Tmax)(Part 2)

    Time frame: through study completion,an average of 156 days

  18. Apparent Clearance (CL/F) (Part 2)

    Time frame: through study completion,an average of 156 days

  19. Apparent Volume of Distribution (Vz/F) (Part 2)

    Time frame: through study completion,an average of 156 days

  20. Terminal Half-Life (T1/2) (Part 2)

    Time frame: through study completion,an average of 156 days

  21. Area Under the Concentration-Time Curve, AUC (Part 2)

    Time frame: through study completion,an average of 156 days

07

Study locations

1 site
  • Peking University First Hospital
    Beijing, Beijing Municipality 100009, China
    • hong zhao · Contact · hongzh@bjmu.edu.cn · 13811123788
    • Xia Zhao, Dr. · Principal investigator
    • Hong Zhang, Dr. · Principal investigator
    • Jicheng Lv, Dr. · Principal investigator
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jan 2027, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2026
First posted
Oct 21, 2026
StartEst.
Oct 15, 2026
Primary completionEst.
Jan 31, 2027
CompletionEst.
Feb 28, 2028
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07886476
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Oct 21, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Jan 31, 2027 (estimated)
Completion
Feb 28, 2028 (estimated)
Last update
Oct 21, 2026

Study contacts

Yating Liu
Contact
yangting.liu@innoventbio.com
0512-69566088

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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