Phase I randomized, double-blind, parallel-controlled, single-dose pharmacokinetic, safety and immunogenicity study of CMAB015 injection versus Cosentyx in healthy Chinese male subjects

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Group A:CMAB015 injection (dosage 1);Group B:Cosenty X(dosage 2); CONDITION: Psoriasis PRIMARY OUTCOME: Serum drug concentration; SECONDARY OUTCOME: Vital sign;Physical examination;Blood routine examination;Blood biochemistry;Urine routine examination;Antinuclear antibody, ANA;12 lead electrocardiograph (ECG);Anti‐drug antibody, ADA;Neutralizing Antibody, NAb;Adverse effect;Pharmacokinetic parameters; INCLUSION CRITERIA: 1. Aged 18‐45 years, healthy males; 2. 50‐75 kg and body mass index(BMI) 18‐28 kg/m2; 3. Volunteers and/or their partners are willing to use medically approved contraception within 6 months after the end of the trail, their partners have no plans to become pregnant, and the volunteers have no plans to donate sperm; 4. Volunteers have the ability to understand the full characteristics and purpose of the study, including the possible risks and side effects of the study; and is able to communicate well with the investigator and to complete the study in accordance with the study protocol; 5. Voluntarily sign the informed consent form.
Epistemonikos ID: ec7cd1b7acb98373322f4537f27820231512601e
First added on: Feb 20, 2024