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

Primary Purpose

Psoriasis

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Secukinumab
Sponsored by
Taizhou Mabtech Pharmaceutical Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Sites / Locations

  • The Second Hospital of Anhui Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biosimilar Product

Reference Product

Arm Description

CMAB015 150 mg Subcutaneous injection in upper arm

Cosentyx(Secukinumab ) 150 mg Subcutaneous injection in upper arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to Maximum Concentration of Secukinumab
Time to Maximum Concentration of Secukinumab after the Single Injection of CMAB015/Cosentyx
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
Half time
Half-time after the Single Injection of CMAB015/Cosentyx
Clearance Rate
Clearance Rate after the Single Injection of CMAB015/Cosentyx
Apparent Volume of Distribution
Apparent Volume of Distribution after the Single Injection of CMAB015/Cosentyx
Terminal phase elimination rate constant
Terminal phase elimination rate constant after the Single Injection of CMAB015/Cosentyx
anti-drug antibodies(ADA)
ADA Positive Rate after the Single Injection of CMAB015/Cosentyx
Neutralization antibodies(Nab)
Neutralizing Antibody Positive Rate after the Single Injection of CMAB015/Cosentyx
Percentage of participants with Adverse Events
Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study

Full Information

First Posted
January 29, 2023
Last Updated
February 15, 2023
Sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05734482
Brief Title
Pharmacokinetic, Safety and Immunogenicity Study of CMAB015 and Cosentyx in Healthy Volunteers
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taizhou Mabtech Pharmaceutical Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Biological: CMAB015 Biological: Cosentyx(Secukinumab )
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biosimilar Product
Arm Type
Experimental
Arm Description
CMAB015 150 mg Subcutaneous injection in upper arm
Arm Title
Reference Product
Arm Type
Active Comparator
Arm Description
Cosentyx(Secukinumab ) 150 mg Subcutaneous injection in upper arm
Intervention Type
Biological
Intervention Name(s)
Secukinumab
Intervention Description
for subcutaneous injection only
Primary Outcome Measure Information:
Title
Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time
Description
Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time After the Single injection of CMAB015/Cosentyx
Time Frame
up to 2688 hours
Title
Maximum Concentration of Secukinumab
Description
Maximum Concentration of Secukinumab After the Single Injection of CMAB015/Cosentyx
Time Frame
up to 2688 hours
Secondary Outcome Measure Information:
Title
Time to Maximum Concentration of Secukinumab
Description
Time to Maximum Concentration of Secukinumab after the Single Injection of CMAB015/Cosentyx
Time Frame
up to 2688 hours
Title
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2688 Hours
Description
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2688 Hours After the Single Injection of CMAB015/Cosentyx
Time Frame
up to 2688 hours
Title
Half time
Description
Half-time after the Single Injection of CMAB015/Cosentyx
Time Frame
up to 2688 hours
Title
Clearance Rate
Description
Clearance Rate after the Single Injection of CMAB015/Cosentyx
Time Frame
up to 2688 hours
Title
Apparent Volume of Distribution
Description
Apparent Volume of Distribution after the Single Injection of CMAB015/Cosentyx
Time Frame
up to 2688 hours
Title
Terminal phase elimination rate constant
Description
Terminal phase elimination rate constant after the Single Injection of CMAB015/Cosentyx
Time Frame
up to 2688 hours
Title
anti-drug antibodies(ADA)
Description
ADA Positive Rate after the Single Injection of CMAB015/Cosentyx
Time Frame
up to 2688 hours
Title
Neutralization antibodies(Nab)
Description
Neutralizing Antibody Positive Rate after the Single Injection of CMAB015/Cosentyx
Time Frame
up to 2688 hours
Title
Percentage of participants with Adverse Events
Description
Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study
Time Frame
up to 2688 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hu Wei, Doctor
Phone
0551-65997164
Email
hwgcp@ayefy.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Jing
Phone
0551-63806061
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hu Wei, Doctor
Organizational Affiliation
The Second Hospital of Anhui University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hu Wei, Doctor
Phone
0551-65997164
Email
hwgcp@ayefy.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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