IgA Nephropathy (IgAN)Phase 1NCT07886476
IBI3034 Study in Healthy Adults and Patients With Primary IgA Nephropathy
A Phase 1 study testing IBI3034 and Telitacicept in people with IgA Nephropathy (IgAN), run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
Part 1 is a Single Ascending Dose (SAD) study, and Part 2 is a Multiple Ascending Dose (MAD) study Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- IgA Nephropathy (IgAN)
- What is being tested?
- IBI3034 and Telitacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2026to 28 Feb 2028
- Phase
- Phase 1
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign the informed consent form (ICF).
- Male or female, aged 18 to 45 years (inclusive).
- Body weight of 50 to 120 kg, BMI of 18.0 to 28.0 kg/m².
- 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.
- Understand and voluntarily sign the informed consent form (ICF).
- Male or female, aged 18 to 65 years (inclusive).
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- Biopsy-confirmed primary IgA nephropathy without known secondary causes within 10 years prior to screening.
- Persistent proteinuria at screening: 24h-UPCR ≥ 0.75 g/g or 24h-UPE ≥ 1.0 g/24h.
- eGFR ≥ 45 mL/min/1.73 m² at screening (CKD-EPI 2021 equation).
- Receiving stable and optimized supportive therapy (ACEI and/or ARB ≥ 12 weeks, stable dose ≥ 4 weeks prior to randomization).
- Participants of childbearing potential must agree to use highly effective contraception and refrain from donating sperm/ova for 6 months after the last dose.
Who cannot join
- 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
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- Participation in another drug or medical device clinical trial within 90 days prior to randomization.
- Systemic corticosteroids (>10 mg/day for >14 consecutive days) or immunosuppressive therapy within 12 weeks prior to randomization.
- Use of renin inhibitors or medications significantly affecting creatinine levels within 4 weeks prior to randomization.
- Prior use of APRIL monoclonal antibodies, BAFF monoclonal antibodies, BAFF/APRIL dual-targeting agents, TACI/BCMA-targeting agents, etc.
- Concurrent nephrotic syndrome or hypoalbuminemia.
- Concurrent other chronic kidney diseases (e.g., diabetic nephropathy, membranous nephropathy).
- Rapidly progressive glomerulonephritis.
- Known or suspected immunodeficiency disorders.
- Poorly controlled blood pressure prior to randomization (systolic BP > 140 mmHg or diastolic BP > 90 mmHg).
- Poorly controlled type 2 diabetes mellitus (HbA1c > 8%).
- History of bone marrow, hematopoietic stem cell, or solid organ transplantation.
- Laboratory abnormalities during screening, such as ALT/AST > 3.0 × ULN, TBIL > 1.5 × ULN, etc.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100009
hong zhao, 13811123788, hongzh@bjmu.edu.cn
Xia Zhao, Dr.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of IBI3034 Following Single Ascending Dose in Healthy Adults and Multiple Ascending Doses in Participants With Primary IgA Nephropathy
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.
- Conditions
- IgA Nephropathy (IgAN)
- Being tested
- IBI3034, Placebo, Telitacicept
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI3034Drug
IBI3034,SC/IV,corresponding dose regimen according to study design
PlaceboDrug
Matching placebo of IBI3034，SC/ IV ，corresponding dose regimen according to study design
TelitaciceptDrug
Telitacicept 240 mg SC QW × 24 doses (Weeks 0-24).
| Study group | Role | What they receive |
|---|---|---|
| IBI3034 group | Experimental | IBI3034，SC/IV,corresponding dose regimen according to study cohort Receives: Drug: IBI3034 |
| Placebo Group | Experimental | Matching placebo of IBI3034， SC/IV ，corresponding dose regimen according to study design Receives: Drug: Placebo |
| Telitacicept (Part 2 only) | Experimental | Telitacicept , 240 mg subcutaneous injection once weekly Receives: Drug: Telitacicept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events (AEs) and serious adverse events (SAEs) following a single dose of IBI3034 in healthy participants(Part 1)
Measured: 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)
Measured: through study completion,an average of 252 days
Secondary outcomes (21)
Pharmacodynamic (PD) Profile: Change from baseline in serum immunoglobulin levels(Part 1)
Measured: through study completion,an average of 169 days
Exploratory Clinical Profile: Change from baseline in UPCR(Part2)
Measured: through study completion,an average of 252 days
Pharmacodynamic (PD) Profile: Change from baseline in serum immunoglobulin levels (Part 2)
Measured: through study completion,an average of 252 days
Exploratory Clinical Profile: Change from baseline in UACR (Part 2)
Measured: through study completion,an average of 252 days
Exploratory Clinical Profile: Change from baseline in eGFR (Part 2)
Measured: through study completion,an average of 252 days
Exploratory Clinical Profile: Change from baseline in hematuria(Part2)
Measured: through study completion,an average of 252 days
Exploratory Clinical Profile: Change from baseline in serum albumin(Part2)
Measured: through study completion,an average of 252 days
Exploratory Clinical Profile: Change from baseline in serum creatinine(Part2)
Measured: through study completion,an average of 252 days
Exploratory Clinical Profile: Change from baseline in blood pressure (both systolic and diastolic)(Part2)
Measured: through study completion,an average of 252 days
Maximum Concentration, Cmax (Part 1)
Measured: through study completion,an average of 57 days
Time to Reach Peak Plasma Concentration (Tmax)(Part 1)
Measured: through study completion,an average of 57 days
Apparent Clearance (CL/F) (Part 1)
Measured: through study completion,an average of 57 days
Apparent Volume of Distribution (Vz/F) (Part 1)
Measured: through study completion,an average of 57 days
Terminal Half-Life (T1/2) (Part 1)
Measured: through study completion,an average of 57 days
Area Under the Concentration-Time Curve, AUC (Part 1)
Measured: through study completion,an average of 57 days
Maximum Concentration, Cmax (Part 2)
Measured: through study completion,an average of 156 days
Time to Reach Peak Plasma Concentration (Tmax)(Part 2)
Measured: through study completion,an average of 156 days
Apparent Clearance (CL/F) (Part 2)
Measured: through study completion,an average of 156 days
Apparent Volume of Distribution (Vz/F) (Part 2)
Measured: through study completion,an average of 156 days
Terminal Half-Life (T1/2) (Part 2)
Measured: through study completion,an average of 156 days
Area Under the Concentration-Time Curve, AUC (Part 2)
Measured: through study completion,an average of 156 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886476
- Sponsor's protocol ID
- CIBI3034A101
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No