Primary IgA nephropathy
Conditions
Interventions
Part A: SAD Phase:Single-dose escalating subcutaneous injections of FB7013 or placebo in healthy participants
Part B: MAD Phase:Multiple dose-escalating subcutaneous injections of FB7013 or placebo in healthy participants
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy participants aged 18 to 45, regardless of gender; 2. Male weight >=50 kg, female weight >= 45 kg, with a body mass index (BMI) ranging from 19 to 28 kg/m^2 (inclusive of 19 and 28 kg/m^2); 3. Participants should have normal laboratory results (or abnormal results with no clinical significance), including routine blood test, blood biochemistry, coagulation indicators and routine urine test; 4. Participants should have normal (or abnormal but clinically insignificant) results from physical examinations, vital signs, electrocardiograms and chest X-rays; 5. Female subjects of childbearing age shall have a negative serum pregnancy test at the time of enrollment; 6. Participants agree that they have no parenting plans during the study period and within 6 months after medication administration, and are able to adopt highly effective contraceptive measures, such as: - Complete abstinence (if it is their self-chosen daily lifestyle) - Intrauterine device (IUD, excluding levonorgestrel-releasing systems) - Female barrier methods (cervical cap or diaphragm with spermicide) - Tubal ligation - Vasectomy for male participants or their partners - Vaginal contraceptive ring; 7. Be willing to cooperate and participate in this trial, comply with all requirements of the protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals with a positive test result for any of the following: Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), Human Immunodeficiency Virus (HIV) antibody, or Treponema pallidum antibody; 2. Screen out individuals who have used any other investigational drugs or medical devices within the preceding 3 months; 3. Having a history of allergies to multiple drugs, or a history of allergic reactions to oligonucleotides or N-acetylgalactosamine (GalNAc); 4. Have a medical history of complement abnormalities, genetic complement deficiency or other immunodeficiencies; 5. Active systemic bacterial or fungal infections requiring antimicrobial treatment, positive T-SPOT screening indicating latent or active tuberculosis, a history of meningitis or recurrent encapsulated bacterial infections; 6. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin exceeds the upper limit of normal (ULN) during the screening period; 7. Any of the following abnormal ECG findings is present during screening, which is clinically significant as judged by the investigator: (1) PR > 200 ms; (2) QTcF >= 450 ms; (3) QRS > 100 ms; 8. Suffering from major cardiovascular diseases, neurological diseases, hematological diseases, infectious diseases, mental illnesses, liver diseases, gastrointestinal diseases, endocrine diseases, immune diseases or kidney diseases, or having a medical history of the aforementioned diseases, or presenting with other known symptoms that may interfere with the absorption, distribution, metabolism or excretion of drugs, or other conditions that, in the opinion of the researcher, will increase the risks to participants; 9. Individuals who have donated blood or lost blood >= 400 ml within 3 months prior to the administration of the investigational product, or those who have received blood transfusions; individuals who have donated blood (including apheresis blood donation) or lost blood >= 200 ml within 1 month prior to the administration of the investigational product; 10. Have used any immunosuppressive agents (such as azathioprine, cyclophosphamide =, or systemic glucocorticoids) or cytotoxic drugs, complement-related inhibitors within 3 months prior to the administration of the investigational product; or have used any siRNA drugs within 12 months prior to the administration of the investigational product; 11. Having received a live attenuated vaccine within 30 days prior to drug administration or planning to receive such a vaccine during the study period; 12. Alcoholics or individuals who regularly consumed alcohol within 3 months prior to screening, that is, those who drank more than 14 units of alcohol per week (one unit equals 360 ml of beer, 45 ml of spirits with 40% alcohol content, or 150 ml of wine), or those with a positive blood alcohol concentration test result; 13. Individuals with a history of drug abuse or positive results in urine drug abuse screening; 14. Screen moderate to heavy smokers within the previous 6 months (average daily smoking > 10 cigarettes or equivalent nicotine intake), including cigarettes, e-cigarettes and nicotine replacement products; 15. Use any medications within 14 days prior to drug administration and during the trial period, including prescription drugs, over-the-counter drugs, and Chinese herbal medicines. Paracetamol with a maximum oral dose of 2g per 24 hours for short-term analgesia is acceptable unless the investigator deems tha
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance and safety of FB7013 injection in healthy participants; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK) evaluation (pharmacokinetic parameters);Exploratory indicators (pharmacodynamic (PD) evaluation indicators (changes in plasma MASP-2 protein from baseline; changes in serum complement components and activity; changes in ADA from baseline and the relationship between ADA changes and MASP-2 protein as well as other complement components and activity); | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Hospital of Anhui Medical University
Outcome results
None listed