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

NCT05734482 | Completed Phase 1

• 1 other identifier: CMAB015-001
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Time to Maximum Concentration of Secukinumab

  up to 2688 hours

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

  up to 2688 hours

• Half time

  up to 2688 hours

• Clearance Rate

  up to 2688 hours

• Apparent Volume of Distribution

  up to 2688 hours

Study Arms (2)

Biosimilar Product

EXPERIMENTAL

CMAB015 150 mg Subcutaneous injection in upper arm

Biological: Secukinumab

Reference Product

ACTIVE COMPARATOR

Cosentyx（Secukinumab ） 150 mg Subcutaneous injection in upper arm

Biological: Secukinumab

Interventions

Secukinumab BIOLOGICAL

for subcutaneous injection only

Biosimilar Product; Reference Product

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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；

Sponsors & Collaborators

• Taizhou Mabtech Pharmaceutical Co.,Ltd: lead

Study Sites (1)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Related Publications (1)

• 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.

  PMID: 39224901 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hu Wei, Doctor

  The Second Hospital of Anhui University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Biological: CMAB015 Biological: Cosentyx（Secukinumab ）

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 21, 2023
• Study Start: February 15, 2023
• Primary Completion: July 3, 2023
• Study Completion: July 3, 2023
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)