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PsoriasisPhase 1NCT05734482

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

A Phase 1 study testing Secukinumab in people with Psoriasis, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Psoriasis
What is being tested?
Secukinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
1 siteChina
Study dates
15 Feb 2023to 3 Jul 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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 <28 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.

Who cannot join

  • 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)；
  • Any one of HBV surface antigen, HCV antibody, HIV antibody, treponema pallidum antibody positive；
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  • Subjects with T-SPOT test positive；
  • 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；
  • 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；
  • 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；
  • Surgery within 4 weeks prior to screening; Or plan to have surgery during the study period；
  • 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；
  • 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；
  • Anti-il-17 antibody active ingredient, excipients or latex allergy；
  • Those with anti-IL-17 antibody and anti-drug antibody positive；
  • Those who have been enrolled in other clinical studies or less than 3 months since the end of the most recent clinical study；
  • 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；
  • Those who Can not tolerate venipunction, has a history of dizziness of needle and blood；
  • Those who have special dietary requirements, or can not accept uniform diet；
  • Other conditions considered inappropriate to be included in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

Other trials in China

About this study

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

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.

Read the detailed description

This is a randomized, double-blind, parallel-controlled, single-dose phase I clinical study in healthy Chinese male subjects. A total of 130 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 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.

Conditions
Psoriasis
Being tested
Secukinumab
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SecukinumabBiological

    for subcutaneous injection only

Study groups in NCT05734482
Study groupRoleWhat they receive
Biosimilar ProductExperimentalCMAB015 150 mg Subcutaneous injection in upper arm
Receives: Biological: Secukinumab
Reference ProductActive comparatorCosentyx（Secukinumab ） 150 mg Subcutaneous injection in upper arm
Receives: Biological: Secukinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time

    Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time After the Single injection of CMAB015/Cosentyx

    Measured: up to 2688 hours

  2. Maximum Concentration of Secukinumab

    Maximum Concentration of Secukinumab After the Single Injection of CMAB015/Cosentyx

    Measured: up to 2688 hours

Secondary outcomes (9)

  1. Time to Maximum Concentration of Secukinumab

    Time to Maximum Concentration of Secukinumab after the Single Injection of CMAB015/Cosentyx

    Measured: up to 2688 hours

  2. Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2688 Hours

    Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2688 Hours After the Single Injection of CMAB015/Cosentyx

    Measured: up to 2688 hours

  3. Half time

    Half-time after the Single Injection of CMAB015/Cosentyx

    Measured: up to 2688 hours

  4. Clearance Rate

    Clearance Rate after the Single Injection of CMAB015/Cosentyx

    Measured: up to 2688 hours

  5. Apparent Volume of Distribution

    Apparent Volume of Distribution after the Single Injection of CMAB015/Cosentyx

    Measured: up to 2688 hours

  6. Terminal phase elimination rate constant

    Terminal phase elimination rate constant after the Single Injection of CMAB015/Cosentyx

    Measured: up to 2688 hours

  7. anti-drug antibodies(ADA)

    ADA Positive Rate after the Single Injection of CMAB015/Cosentyx

    Measured: up to 2688 hours

  8. Neutralization antibodies(Nab)

    Neutralizing Antibody Positive Rate after the Single Injection of CMAB015/Cosentyx

    Measured: up to 2688 hours

  9. Percentage of participants with Adverse Events

    Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study

    Measured: up to 2688 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start15 Feb 2023
  3. Primary completion3 Jul 2023
  4. Study completion3 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Biological: CMAB015 Biological: Cosentyx（Secukinumab ）
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05734482
Sponsor's protocol ID
CMAB015-001
Status last verified
Apr 2024
First submitted
29 Jan 2023
Last updated
10 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yao F, Wang C, Ding J, Zhang Q, Zheng L, Zhang Q, Yang T, Zhang X, Shan Y, Hou S, Wang H, Zhou R, Hu W. A Randomized, Double-Blind, Parallel-Group Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of CMAB015, a Candidate Secukinumab Biosimilar, with Its Reference Product Cosentyx(R) in Healthy Chinese Male Subjects. Drug Des Devel Ther. 2024 Aug 29;18:3891-3901. doi: 10.2147/DDDT.S470619. eCollection 2024.

    PubMed 39224901

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Secukinumab in people with Psoriasis, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time (time frame: up to 2688 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05734482, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.

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