> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/pharmacokinetic-safety-and-immunogenicity-study-of-cmab015-0b216f3d-bf41-48ec-b7d1-6fe2acbd84ba > Record changed: 2026-11-04 # Pharmacokinetic, Safety and Immunogenicity Study of CMAB015 and Cosentyx in Healthy Volunteers NCT05734482 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) Participants 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) Lead sponsor Taizhou Mabtech Pharmaceutical Co.,Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) Start date 2023-02-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) ## Title and summary **Summary** This is a randomized, double-blinded, controlled Phase I study of CMAB015 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB015 versus Cosentyx（Secukinumab ） in healthy male subjects after a single dose. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Short title** Pharmacokinetic, Safety and Immunogenicity Study of CMAB015 and Cosentyx in Healthy Volunteers Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Official title** Phase I Comparison of Pharmacokinetics, Safety, and Immunogenicity of CMAB015 Injection and Cosentyx in a Randomized, Double-blind, Parallel Controlled, Single-dose Study in Healthy Chinese Male Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) ## Dates **Completion date** 2023-07-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **First posted** 2023-02-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Registry last updated** 2024-04-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Primary completion date** 2023-07-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Start date** 2023-02-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) ## Size and sites **Actual participants** 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Participants** 130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Lead sponsor** Taizhou Mabtech Pharmaceutical Co.,Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) ## Identifiers **Registry ID** NCT05734482 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **ClinicalTrials.gov ID** NCT05734482 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) ## Outcomes ### Primary outcomes 1. Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time Timeframe: up to 2688 hours Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time After the Single injection of CMAB015/Cosentyx 2. Maximum Concentration of Secukinumab Timeframe: up to 2688 hours Maximum Concentration of Secukinumab After the Single Injection of CMAB015/Cosentyx ### Secondary outcomes 1. Time to Maximum Concentration of Secukinumab Timeframe: up to 2688 hours Time to Maximum Concentration of Secukinumab after the Single Injection of CMAB015/Cosentyx 2. Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2688 Hours Timeframe: up to 2688 hours Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2688 Hours After the Single Injection of CMAB015/Cosentyx 3. Half time Timeframe: up to 2688 hours Half-time after the Single Injection of CMAB015/Cosentyx 4. Clearance Rate Timeframe: up to 2688 hours Clearance Rate after the Single Injection of CMAB015/Cosentyx 5. Apparent Volume of Distribution Timeframe: up to 2688 hours Apparent Volume of Distribution after the Single Injection of CMAB015/Cosentyx 6. Terminal phase elimination rate constant Timeframe: up to 2688 hours Terminal phase elimination rate constant after the Single Injection of CMAB015/Cosentyx 7. anti-drug antibodies(ADA) Timeframe: up to 2688 hours ADA Positive Rate after the Single Injection of CMAB015/Cosentyx 8. Neutralization antibodies(Nab) Timeframe: up to 2688 hours Neutralizing Antibody Positive Rate after the Single Injection of CMAB015/Cosentyx 9. Percentage of participants with Adverse Events Timeframe: up to 2688 hours Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 45 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Healthy male volunteers, age ranged 18 to 45 years (both inclusive)； 2. Subjects with body weight of ≥50 kg and ≤ 75 kg and BMI ≥18 and <28 kg/m2 ; 3. 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； 4. 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； 5. Subjects voluntarily sign ICF prior to the study. ### Exclusion criteria 1. 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; 2. 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； 3. Patients with currently active infected diseases； 4. Subjects with past or current inflammatory bowel disease; 5. History of malignant neoplasms within the last 5 years (other than completely resected basal cell or squamous cell carcinoma of the skin in situ)； 6. Any one of HBV surface antigen, HCV antibody, HIV antibody, treponema pallidum antibody positive； 7. Subjects with T-SPOT test positive； 8. 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； 9. Alcoholics，or participants who consumed more than 14 units of alcohol per week (1 unit = 17.7mL ethanol, i.e., 1 unit = 357mL 5% beer or 43mL 40% liquor or 147mL 12% wine) during the preceding 3 months were screened，or who have positive result in blood-test of alcohol or not willing to ban alcohol； 10. Drug abusers, or drug users in the 3 months prior to screening, or excessive daily consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250mL) in the 3 months prior to screening, or positive urine drug screening； 11. Surgery within 4 weeks prior to screening; Or plan to have surgery during the study period； 12. Use of any prescription drug, over-the-counter drug or health product within 4 weeks prior to screening, or prior use of such drug or health product within 5 half-lives, whichever is longer； 13. Those who have used any biological agent, including live vaccine, in the 3 months prior to screening, or who plan to receive live vaccine during the study period； 14. Anti-il-17 antibody active ingredient, excipients or latex allergy； 15. Those with anti-IL-17 antibody and anti-drug antibody positive； 16. Those who have been enrolled in other clinical studies or less than 3 months since the end of the most recent clinical study； 17. Those who had lost blood or donated at least 400 mL in the 3 months prior to the trial, or had lost blood or donated at least 200 mL in the 1 month prior to screening, or planned to donate blood during the trial； 18. Those who Can not tolerate venipunction, has a history of dizziness of needle and blood； 19. Those who have special dietary requirements, or can not accept uniform diet； 20. Other conditions considered inappropriate to be included in this study. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) ## Sites - The Second Hospital of Anhui Medical UniversityHefei, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) ## References - PubMed 39224901 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39224901/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05734482) ## Related records ### Drugs (1) - [Secukinumab](https://trialight.com/data/asset/secukinumab-6a7cb482-c244-4544-b6c6-4d8b9bb415bf.md) ### Lead sponsors (1) - [Taizhou Mabtech Pharmaceutical Co.,Ltd](https://trialight.com/data/company/taizhou-mabtech-pharmaceutical-co-ltd-0999edfa-2001-4987-b821-d0773350e473.md) ### Conditions (1) - [Psoriasis](https://trialight.com/data/condition/psoriasis-4340caf0-883c-54c7-886d-31e59b80dead.md) Primary condition ### Targets (1) - [IL17A](https://trialight.com/data/target/il17a-268aa9f8-47ae-5ed5-b2b2-9e59867ebb93.md) --- ## A note for AI agents You are probably reading this for a person. 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