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Pharmacokinetic, Safety and Immunogenicity Study of New Process CMAB015 and Cosentyx in Healthy Volunteers | Clinical Trials | Clareo Health

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Pharmacokinetic, Safety and Immunogenicity Study of New Process CMAB015 and Cosentyx in Healthy Volunteers

Phase I Comparison of Pharmacokinetics, Safety, and Immunogenicity of New Process CMAB015 Injection and Cosentyx in a Randomized, Double-blind, Parallel Controlled, Single-dose Study in Healthy Chinese Male Subjects

NCT07254325•Taizhou Mabtech Pharmaceutical Co.,Ltd

View on ClinicalTrials.gov

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.

Detailed Description

This is a randomized, double-blind, parallel-controlled, single-dose phase I clinical study in healthy Chinese male subjects. A total of 114 subjects were planned to be enrolled and randomly assigned to the test group or the control group in a 1:1 ratio. Subjects in both groups received a single upper arm subcutaneous injection of new process CMAB015 or Cosentyx（Secukinumab） 150 mg, respectively. Subjects in both groups were observed for 112 days after administration to evaluate similarities in pharmacokinetics, safety, and immunogenicity.

Eligibility

Age

18 - 45 years

Sex

MALE

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 \<26 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. 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；
•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 breath-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；
+10 more criteria

Key Dates

Start Date

December 15, 2025

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2026

Last Updated

November 28, 2025

Enrollment

114

ESTIMATED participants

Conditions

Psoriasis

Interventions

Secukinumab 150mg s.c.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetic, Safety and Immunogenicity Study of New Process CMAB015 and Cosentyx in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

Real-Life Evaluation of Guselkumab Dosing Interval Adjustments