Pharmacokinetic, Safety and Immunogenicity Study of New Process CMAB015 and Cosentyx in Healthy V… (NCT07254325) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Pharmacokinetic, Safety and Immunogenicity Study of New Process CMAB015 and Cosentyx in Healthy Volunteers
China114 participantsStarted 2025-12-15
Plain-language summary
This is a randomized, double-blinded, controlled Phase I study of new process CMAB015 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of new process CMAB015 versus Cosentyx（Secukinumab ） in healthy male subjects after a single dose.
Who can participate
Age range18 Years – 45 Years
SexMALE
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Inclusion criteria
✓. Healthy male volunteers, age ranged 18 to 45 years (both inclusive)；
✓. Subjects with body weight of ≥50 kg and ≤ 75 kg and BMI ≥18 and \<26 kg/m2 ;
✓. Subjects and their partners were willing to use medically approved contraceptive methods within 6 months of study administration, partners did not plan to become pregnant, subjects did not plan to donate sperm；
✓. The subjects have the ability to understand the full characteristics and objectives of the study, including the possible risks and side effects of the study; Moreover, the subjects can communicate well with researchers and complete the research according to the regulations；
✓. Subjects voluntarily sign ICF prior to the study.
Exclusion criteria
✕. After comprehensive examination (vital signs, physical examination, electrocardiogram, chest radiography, abdominal B-ultrasound, blood routine, urine routine, blood biochemistry, etc.), any examination item was judged abnormal by the investigator and had clinical significance;
✕. Patients with serious diseases such as cardiovascular system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematopoietic system, immune system, or any of the above diseases；
✕. Patients with currently active infected diseases；
✕. Subjects with past or current inflammatory bowel disease;
✕. History of malignant neoplasms within the last 5 years (other than completely resected basal cell or squamous cell carcinoma of the skin in situ)；
What they're measuring
1
Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time
✕. Any one of HBV surface antigen, HCV antibody, HIV antibody, treponema pallidum antibody positive；
✕. Subjects with T-SPOT test positive. If the initial T-SPOT test result is inconclusive, a repeat test may be performed. If the result remains inconclusive or positive, the individual should be excluded；
✕. Those who smoked more than 5 cigarettes per day in the 6 months before screening and did not cooperate with smoking bans during the study period；