Phase I Randomized, Open-label, Parallel-controlled, Pharmacokinetic and Safety Study of BR201 Injection Versus Cosentyx in Healthy Male Subjects

Psoriasis Clinical Trial

Official title:

Phase I Randomized, Open-label, Parallel-controlled, Pharmacokinetic and Safety Study of BR201 Injection Versus Cosentyx in Healthy Male Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06126718
• Other study ID #: BR201-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: November 2023
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: BioRay Pharmaceutical Co., Ltd.
• Contact: Yu Cao, Doctor
• Phone: +86-18661809090
• Email: caoyu1767[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

• 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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• BR201
One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given
• Cosentyx(Secukinumab )
One-dosage on D1 and review pharmacokinetic and safety until D112 after drug given

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioRay Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-inf	Area under the cure from 0 to infinite	Till Day112
Primary	Cmax	The max concentration after drug given	Till Day112
Secondary	AUC0-t	Area under the cure from 0 to some time	Till Day112
Secondary	Tmax	The time for drug enlarge to max concentration	Till Day112
Secondary	T1/2	Half life	Till Day112
Secondary	Vz/F	Apparent volume of distribution	Till Day112
Secondary	CL/F	Clearance	Till Day112
Secondary	Immunogenicity	ADA	Till Day112
Secondary	AE	Advance event	Till Day112
Secondary	Evaluation about injection site reactions	Evaluation about injection site reactions	0 mins, 0.5 hours, 24 hours and 72 hours after drug given
Secondary	ECG	ECG	Till Day112
Secondary	Incidence of laboratory abnormalities	To be summarized using descriptive statistics	Till Day112