Healthy
Conditions
Brief summary
This is a randomized, single-blinded, placebo controlled, single ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) and immunogenicity of KJ103 in healthy subjects.
Detailed description
This single ascending dose (SAD), randomized, single-blinded, placebo controlled study is the first study and it is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of KJ103 in healthy subjects after a single intravenous dose. It will include up to 34 healthy subjects in up to five dose groups.
Interventions
DRUGKJ103
Recombinant Immunoglobulin G Cleaving Enzyme
DRUGPlacebo
Placebo
Sponsors
Shanghai Bao Pharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female between the ages of 18 and 55 years, inclusive. 2. Male body weight ≥50kg, female body weight ≥45kg, body mass index (BMI) within 18 kg/m2to 35 kg/m2, inclusively. 3. Immunoglobulin (IgG) levels at screening is within the normal range. 4. 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
1. History of or diagnosis at screening of any clinically significant immunodeficiency including but not limited to immunoglobulin A deficiency. 2. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease. 3. Any clinically significant illness in the 28 days prior to the first study drug administration. 4. Any history of tuberculosis. 5. Positive screening results to HIV Ag/Ab combo, syphilus, hepatitis A, hepatitis B surface antigen or hepatitis C virus tests. 6. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration. 7. Current use of tobacco or nicotine-containing products exceeding 10 cigarettes per day or equivalent. 8. 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. 9. Female who is lactating. 10. Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AE | Day 1 through Day 14 | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational drug |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Up to 144 hours postdose | The maximum measured concentration of the analysis in serum |
| Tmax | Up to 144 hours postdose | Time To Reach The Maximal serum Concentration |
| t½ | Up to 144 hours postdose | Terminal Elimination Half-Life |
| AUC0-inf | Up to 144 hours postdose | Area Under the Serum Concentration Versus Time Curve From Zero to Infinity |
| IgG level | Day 1 through Day 63 | Concentration of Immunoglobulin G in serum |
Countries
New Zealand
Outcome results
None listed