enzilumab Study in Healthy Korean Subjects

Not Applicable

Completed

• Conditions: Codes for special purposes

• Registration Number: KCT0006851
• Lead Sponsor: Telcon RF Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-08-05
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

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 < 13.0 or > 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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified