None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : Intervention 1: Lenzilumab 1 mg/kg (Take investigational product through a vein for 1 hour.)
Intervention 2: Lenzilumab 3 mg/kg (Take investigational product thro
Sponsors
Telcon RF Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy adults aged 19 to 45 at the time of screening tests 2) Those with a body mass index (BMI) of 18.5 kg/m2 to 29.9 kg/m2 at the time of screening test ? Body mass index (BMI) = Weight (kg)/[Height (m)]2 3) After hearing sufficient explanation of this clinical trial and fully understanding it, a person who voluntarily decided to participate and agreed in writing to comply with precautions 4) A person who is suitable for the clinical trial of this test when determining a investigator through physical examination, clinical laboratory examination, or examination by interview
Exclusion criteria
Exclusion criteria: 1) A person with a history of diseases or history that are believed to affect clinical trials such as mediastinal, kidney, nervous, immune, respiratory, digestive, endocrine, blood•tumor, cardiovascular, urological, and psychiatric diseases 2) A person whose clinical laboratory test results are not suitable for participation in this test, or who shows clinically significant findings in ECG, chest X-ray - WBC = 3.5×10^9/L or absolute neutrophil = 2.0×10^9/L - Hb 16.0 gm/dL - Creatinine = 2 mg/dL - Total bilirubin = 2 mg/dL - ALT/AST = 2 ULN (Upper limit of normal) - Significant findings in Urine dipstick - QTc (Bazett) > 450 ms (Male), 460 ms (Female) - QRS interval > 120 ms or PR interval > 210 ms - Acute or chronic lung disease findings in chest X-ray - Oxygen saturation and abnormal findings of DLCO - A person who is positive as a result of a serum test (hepatitis B, hepatitis C, HIV, syphilis test) 3) A person who has a history of hypersensitivity or clinically significant hypersensitivity to drugs including the same type of defense antibodies and immunoglobulin and other drugs (aspirin, antibiotic, etc.) 4) A person who have been tested positive for COVID-19. A person who has been treated for COVID-19 or has been given a COVID-19 vaccine within 3 months prior to the scheduled date of administration of the investigational product 5) A person who has a history of administering vaccines within 1 month of the scheduled date of investigational product for clinical trials 6) Current smokers who have smoked more than 10 cigarettes a day 7) Those who have a drinking history of more than 4 units a day (1 unit = 10g of pure alcohol, 300mL of beer, 1 glass of wine, 1 glass of soju) or cannot abstain from drinking from 3 days before the scheduled date of investigational product administration to the hospitalization period 8) A person who has a history of drug abuse or has tested positive for an abused drug in a urine screening test 9) Those who have taken prescription drugs, general medicines, health functional foods, vitamin preparations, or herbal medicines within 2 weeks before the scheduled date of administration of investigational product, or those who are expected to take them 10) Those who participated in other clinical trials within 6 months before the first scheduled date of administration of investigational product 11) A person who donated whole blood within 3 months prior to the expected first dose date or donated ingredients within 1 month prior to the expected first dose date, or received a blood transfusion within 1 month prior to the expected first dose date 12) Those who are unable to use medically recognized double contraceptives or medically acceptable contraceptives by him/herself, the spouse or the partner up to 6 months after administration of investigational product, and who disagree not to donate sperm until that period ? Medically acceptable contraceptive method - The use of intrauterine devices with proven pregnancy failure rates in spouses (or partners) or themselves - Use of both men and women's methods of blocking contraception and a spermicide at the same time - Surgery of the person or partner(vasectomy, tubectomy/ligation, hysterectomy) 13) Pregnant women or lactating women 14) A person who determines that the investigator is inappropriate to participate in clinical trials due to oth
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation;Pharmacokinetics evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactSung Yeun Bae
Seoul National University Hospital
Outcome results
None listed