PsoriasisPhase 1NCT06126718
Phase I Randomized, Open-label, Parallel-controlled, Pharmacokinetic and Safety Study of BR201 Injection Versus Cosentyx in Healthy Male Subjects
A Phase 1 study testing BR201 and Cosentyx（Secukinumab ） in people with Psoriasis, run by BioRay Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, open-label, controlled Phase I study of BR201 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of BR201 versus Cosentyx（Secukinumab ） in healthy male subjects after a single dose. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- BR201 and Cosentyx（Secukinumab ）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2024to 19 Aug 2024
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to understand and sign informed consent form；
- Healthy men 18-50 years of age at time of consent；
- Body weight of ≥50 kg and ≤ 80 kg and BMI ≥19 and ≤ 26 kg/m2.
Who cannot join
- Clinical laboratory examination results are abnormal and with clinical significance, or other clinical findings indicate diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, tumor, pulmonary, immune, mental or cardiovascular and cerebrovascular diseases) with clinical significance;
- Use of IL-17 or other monoclonal antibodies in the last 6 months;
- Positive for anti-IL-17 antibodies at screening;
- Evidence of tuberculosis infection;
- With active infection at screening or have been hospitalized for a serious infection during the 8 months prior to screening or use of antibiotics within 2 weeks of enrollment;
- Anti-IL-17 antibody active ingredient, excipients or latex allergy;
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- With severe bleeding factors that affect venous blood collection or unwilling to undergo venipuncture;
- Use drug treatment (including prescription drugs, over-the-counter drugs, health product etc.) within 14 days before screening;
- Surgery within 2 months prior to screening; or plan to have surgery during the study period;.
- Have received live vaccines within 6 months prior to screening, or have used any vaccines within 4 weeks prior to screening, or plan to be vaccinated during the trial.;
- History of malignant neoplasms；
- Hepatitis B and/or Hepatitis C; or HIV antigen/antibody positive; or Treponema pallidum antibody positive; .
- Blood donation or massive blood loss (> 400 ml) within 3 months or blood loss (> 200 ml) within 1 month before signing the informed consent; or plan to donate blood during the trial;
- Have a history of drug or substance abuse before screening; or positive drug abuse test results on the day of check-in;
- Acute disease occurred or with concomitant medication from the screening to use of the study drug.;
- Have pregnancy plan or sperm donation plan during the whole trial period and within 6 months after the completion of the study;
- Other conditions considered inappropriate to be included in this study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
About this study
This is a randomized, open-label, controlled Phase I study of BR201 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of BR201 versus Cosentyx（Secukinumab ） in healthy male subjects after a single dose.
- Conditions
- Psoriasis
- Being tested
- BR201, Cosentyx（Secukinumab ）
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR201Drug
One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given
Cosentyx（Secukinumab ）Drug
One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given
| Study group | Role | What they receive |
|---|---|---|
| BR201 | Experimental | Not described Receives: Drug: BR201 |
| Cosentyx (Secukinumab) | Active comparator | Not described Receives: Drug: Cosentyx（Secukinumab ） |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf
Area under the cure from 0 to infinite
Measured: Till Day112
Cmax
The max concentration after drug given
Measured: Till Day112
Secondary outcomes (10)
AUC0-t
Area under the cure from 0 to some time
Measured: Till Day112
Tmax
The time for drug enlarge to max concentration
Measured: Till Day112
T1/2
Half life
Measured: Till Day112
Vz/F
Apparent volume of distribution
Measured: Till Day112
CL/F
Clearance
Measured: Till Day112
Immunogenicity
ADA
Measured: Till Day112
AE
Advance event
Measured: Till Day112
Evaluation about injection site reactions
Evaluation about injection site reactions
Measured: 0 mins, 0.5 hours, 24 hours and 72 hours after drug given
ECG
ECG
Measured: Till Day112
Incidence of laboratory abnormalities
To be summarized using descriptive statistics
Measured: Till Day112
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start21 Feb 2024
- Primary completion19 Aug 2024
- Study completion19 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioRay Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Cao, Doctor, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126718
- Sponsor's protocol ID
- BR201-101
- Status last verified
- Jun 2025
- First submitted
- 2 Nov 2023
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Randomized, Open-label, Parallel-controlled, Pharmacokinetic and Safety Study of BR201 Injection Versus Cosentyx in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT06126718
- Acronym / sponsor ID
- BR201-101
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- BioRay Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 19 Aug 2024 (actual)
- Study completion
- 19 Aug 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, controlled Phase I study of BR201 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of BR201 versus Cosentyx（Secukinumab ） in healthy male subjects after a single dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BR201 | Experimental | Drug: BR201 |
| Cosentyx (Secukinumab) | Active comparator | Drug: Cosentyx（Secukinumab ） |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Able to understand and sign informed consent form；
- Healthy men 18-50 years of age at time of consent；
- Body weight of ≥50 kg and ≤ 80 kg and BMI ≥19 and ≤ 26 kg/m2.
Key exclusion criteria (17 listed)
- Clinical laboratory examination results are abnormal and with clinical significance, or other clinical findings indicate diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, tumor, pulmonary, immune, mental or cardiovascular and cerebrovascular diseases) with clinical significance;
- Use of IL-17 or other monoclonal antibodies in the last 6 months;
- Positive for anti-IL-17 antibodies at screening;
- Evidence of tuberculosis infection;
- With active infection at screening or have been hospitalized for a serious infection during the 8 months prior to screening or use of antibiotics within 2 weeks of enrollment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BR201One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given | Drug | BR201 |
| Cosentyx（Secukinumab ）One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given | Drug | Cosentyx (Secukinumab) |
Primary outcome
AUC0-inf
Time frame: Till Day112
Area under the cure from 0 to infinite
Cmax
Time frame: Till Day112
The max concentration after drug given
10 secondary outcomes
AUC0-t
Time frame: Till Day112
Tmax
Time frame: Till Day112
T1/2
Time frame: Till Day112
Vz/F
Time frame: Till Day112
CL/F
Time frame: Till Day112
Immunogenicity
Time frame: Till Day112
AE
Time frame: Till Day112
Evaluation about injection site reactions
Time frame: 0 mins, 0.5 hours, 24 hours and 72 hours after drug given
ECG
Time frame: Till Day112
Incidence of laboratory abnormalities
Time frame: Till Day112
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Cao, Doctor principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BR201 and Cosentyx（Secukinumab ） in people with Psoriasis, run by BioRay 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 3 inclusion and 17 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 24 Jun 2025. 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?
AUC0-inf (time frame: Till Day112). 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?
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 24 Jun 2025.