New biosimilar aims to offer cheaper psoriasis treatment
NCT ID NCT07254325
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 1 study compares a new biosimilar drug, CMAB015, to the approved psoriasis treatment Cosentyx (secukinumab). The trial involves 114 healthy Chinese men who receive a single injection. Researchers will measure how the drug moves through the body, its safety, and whether the immune system reacts to it. This is an early step to see if the biosimilar is similar enough to Cosentyx to move into patient testing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Secukinumab (biosimilar CMAB015)
- What this could lead to
- If successful, this could lead to a more affordable version of Cosentyx for psoriasis, potentially lowering treatment costs.
- What could go wrong
- This is an early Phase 1 trial in healthy volunteers, not patients. It only tests safety and drug levels, not whether it works for psoriasis. The biosimilar may not perform the same as the original drug.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 114 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
-
Jun 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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; 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Shanghai Jiaotong University School of Medicine
Shanghai, China
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Other studies related to the condition(s) this trial covers.
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