organ transplantation
Conditions
Interventions
0.01 mg/kg :0.01 mg/kg KJ103
0.04 mg/kg:0.04 mg/kg KJ103
0.12 mg/kg:0.12 mg/kg KJ103
0.25 mg/kg:0.25 mg/kg KJ103
0.4 mg/kg:0.4 mg/kg KJ103
placebo:placebo
Sponsors
Suzhou Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must have the ability to understand and the willingness to sign a written informed consent document (prior to the initiation of the study and any study procedures). 2. Subjects must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures. 3. Male or female between the ages of 18 and 55 years, inclusive, at the screening visit. 4. Male body weight =50kg, female body weight =45kg, body mass index (BMI) within 18 kg/m2to 35 kg/m2, inclusively. 5. Immunoglobulin (IgG) levels at screening is within the normal range; 6. Considered healthy by the investigator. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, as well as a complete physical examination including vital signs, 12-lead ECG, hematology, biochemistry, and urinalysis;
Exclusion criteria
Exclusion criteria: 1. History of or diagnosis at screening of any clinically significant immunodeficiency including but not limited to immunoglobulin A deficiency. 2. History of significant hypersensitivity to ingredient of KJ103 or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs. 3. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease. 4. Use of any prescription medication within 14 days prior to the first study drug administration or 5 times of T1/2 (if known), whichever is longer. Or of over-the-counter medication (including herbal preparations and supplements. Subjects could use them unless approved by investigator and medical monitor) within 7 days prior to the first study drug administration or 5 times of T1/2 (if known), whichever is longer. 5. Any history of tuberculosis. 6. Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus tests. 7. Any other clinically significant abnormalities in laboratory test results at Screening that would, in the opinion of an Investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data. 8. Donation blood or massive blood loss (=500ml) in the 3 months prior to the first study drug administration. 9. Subjects who had been vaccinated within 4 weeks prior to dosing or were scheduled to be vaccinated within 28 days of dosing during the study. Subjects will be allowed to enroll if any of the following conditions are met: a) Subjects who had received COVID-19 vaccine or enhanced COVID-19 vaccine >4 weeks before dosing were eligible for enrollment in the study. b) Subjects who wish to receive a COVID-19 vaccine or a COVID-19 booster vaccine >8 weeks after study drug administration may be enrolled in this study. 10. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration. 11. Current use of tobacco or nicotine-containing products exceeding 10 cigarettes per day or equivalent. 12. Received an investigational drug (or was using an investigational device at the time) within 30 days prior to screening, or at least 5 times the respective elimination half-life (if known), whichever is longer. 13. Female who is lactating. 14. Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration. 15. The subject or his or her partner has planned a birth or is unwilling to use effective contraception during the trial or for six months after the end of the trial 16. Investigator considers is unsuitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence and severity of treatment-emergent adverse event (TEAE) and serious adverse event (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| serum pharmacokinetics (PK) ;IgG level;immunogenicity; | — |
Countries
China
Contacts
Public ContactYanxia Yu
Suzhou Municipal Hospital
Outcome results
None listed