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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Biological: Secukinumab

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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The Second Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 <28 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；
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 blood-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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biosimilar Product; CMAB015 150 mg Subcutaneous injection in upper arm	Biological: Secukinumab; for subcutaneous injection only
Active Comparator: Reference Product; Cosentyx（Secukinumab ） 150 mg Subcutaneous injection in upper arm	Biological: Secukinumab; for subcutaneous injection only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 2688 hours
Maximum Concentration of Secukinumab	Maximum Concentration of Secukinumab After the Single Injection of CMAB015/Cosentyx	up to 2688 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Maximum Concentration of Secukinumab	Time to Maximum Concentration of Secukinumab after the Single Injection of CMAB015/Cosentyx	up to 2688 hours
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	up to 2688 hours
Half time	Half-time after the Single Injection of CMAB015/Cosentyx	up to 2688 hours
Clearance Rate	Clearance Rate after the Single Injection of CMAB015/Cosentyx	up to 2688 hours
Apparent Volume of Distribution	Apparent Volume of Distribution after the Single Injection of CMAB015/Cosentyx	up to 2688 hours
Terminal phase elimination rate constant	Terminal phase elimination rate constant after the Single Injection of CMAB015/Cosentyx	up to 2688 hours
anti-drug antibodies(ADA)	ADA Positive Rate after the Single Injection of CMAB015/Cosentyx	up to 2688 hours
Neutralization antibodies(Nab)	Neutralizing Antibody Positive Rate after the Single Injection of CMAB015/Cosentyx	up to 2688 hours
Percentage of participants with Adverse Events	Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study	up to 2688 hours

Collaborators and Investigators

• Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd
• Investigators: Principal Investigator: Hu Wei, Doctor, The Second Hospital of Anhui University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): July 3, 2023
• Study Completion (Actual): July 3, 2023

Study Registration Dates

• First Submitted: January 29, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: CMAB015-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No