Tolerability, Safety and Pharmacokinetic Study of Humanized Anti-CD6 Monoclonal Antibody Injection in Chinese Psoriasis

NCT ID: NCT02649270

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-10-31

Brief Summary

The humanized recombinant anti-CD6 monoclonal antibody Injection (T1h) has been approved for psoriasis in India. The first trial in China is to evaluate the tolerability, safety, pharmacodynamic, pharmacokinetics and preliminary efficacy of T1h for patients with psoriasis.

Detailed Description

The humanized recombinant anti-CD6 monoclonal antibody (T1h) is developed whose ligand binding properties of the original murine monoclonal antibody are preserved on the CD6 molecule. T1h monoclonal antibody has been approved for clinical studies of autoimmune diseases in Cuba and India, such as psoriasis and rheumatoid arthritis (RA).

Single and multiple dose based tolerability, safety and pharmacokinetic phase 1 Study of Humanized Anti-CD6 Monoclonal Antibody Injection in Chinese patients with psoriasis, 40 patients are enrolled. They are divided into 4 groups (0.2mg/kg, 0.4mg/kg, 0.8mg/kg, 1.6mg/kg) and each group includes 10 patients. First, these doses are all single-dose administration gradually from low then the doses 0.4mg/kg, 0.8mg/kg and 1.6mg/kg are multi-dose administration gradually from low.

Conditions

Psoriasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group1

10 Psoriasis patients,T1h 0.2mg/kg,only single dose administration at week 1.

Group Type: EXPERIMENTAL

T1h

Intervention Type: BIOLOGICAL

Given T1h for different groups by vein to evaluate safety and tolerability;Collecting blood samples for pharmacokinetics and pharmacodynamics after administration.

Group2

10 Psoriasis patients,T1h 0.4mg/kg ,first administration at week 1 and continous administration from fifth week for 9 weeks.

Group Type: EXPERIMENTAL

T1h

Intervention Type: BIOLOGICAL

Given T1h for different groups by vein to evaluate safety and tolerability;Collecting blood samples for pharmacokinetics and pharmacodynamics after administration.

Group3

10 Psoriasis patients,T1h 0.8mg/kg,first administration at week 1 and continous administration from fifth week for 9 weeks.

Group Type: EXPERIMENTAL

T1h

Intervention Type: BIOLOGICAL

Given T1h for different groups by vein to evaluate safety and tolerability;Collecting blood samples for pharmacokinetics and pharmacodynamics after administration.

Group4

10 Psoriasis patients,T1h 1.6mg/kg,first administration at week 1 and biweekly from fifth week for 9 weeks.

.

Group Type: EXPERIMENTAL

T1h

Intervention Type: BIOLOGICAL

Given T1h for different groups by vein to evaluate safety and tolerability;Collecting blood samples for pharmacokinetics and pharmacodynamics after administration.

Interventions

T1h

Given T1h for different groups by vein to evaluate safety and tolerability;Collecting blood samples for pharmacokinetics and pharmacodynamics after administration.

Intervention Type: BIOLOGICAL

Other Intervention Names

Anti-CD6 Monoclonal Antibody

Eligibility Criteria

Inclusion Criteria

1. Age ranged from 18 to 55 years, males or females ( no less than 3 patients in each dose group)

2. Patients with chronic plaque psoriasis for at least 6 months (until patients with an informed consent) with or without arthritis psoriasis

3. BSA≥3% or PASI≥10

4. PGA≥3

5. Patients were eligible if wash-out period was no less than the time as follows:

• 2 weeks for topical retinoic acid or glucocorticoid therapy
• 6 months for retinoic acid of this kind drugs therapy
• 2 weeks for light therapy
• 4 weeks for Psoralen combined with UV-A therapy
• 4 weeks for methotrexate(MTX),cyclophosphamide,cyclosporine and other immunosuppressive therapy
• 7 half life time periods for other systemic immunosuppressive therapy
• 8 weeks for Biological agents for psoriasis therapy

6. Fertile males or females who are willing to adopt contraceptive methods (e.g. hormonal pitch, intrauterine device, condoms)

7. Patients were voluntary to sign a written informed consent.

Exclusion Criteria

1. The females were pregnant, or lactating or showed positive urine pregnancy reaction during screening.

2. Patients with erythroderma or pustular psoriasis.

3. Patients receiving glucocorticoid systemic drug therapy.

4. Patients previously or currently suffered from autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome ), or suffering from primary or secondary immunodeficiency or human immunodeficiency virus

5. Patients with any active infection (nail bed induced fungal infections were excluded), chronic infections, and tuberculosis history.

6. Patients with severe heart disease, heart failure, asthma, chronic obstructive pulmonary disease or neuropsychiatric diseases.

7. Patients previously or currently suffered from tumors including solid tumors, hematologic malignancies and carcinoma in situ.

8. Patients with positive tests for hepatitis B surface antigen (HBsAg), hepatitis C serology (HCV-Ab) or human immunodeficiency virus (HIV-Ab)

9. Patients with Hemoglobin < 90 g/L, white blood cell count <3.5 × 10^9 / L, neutrophil count <1.5 × 10^9 / L, or platelet count <80 × 10^9 / L

10. Patients with more than doubled serum cereal third transaminase(ALT )and glutamic-oxaloacetic transaminase(AST) as the upper limit of the reference value or serum creatinine values were above the upper limit of the reference.

11. Patients with a history of drug abuse or alcoholism

12. Patients were allergic to a recombinant biologic agent or any component of proteins derived from murine

13. Patients with surgery within three months or any planned surgery or laser skin treatment within six months

14. Patients received any vaccination within 28 days

15. Patients received any experimental drug treatment within three months

16. Patients were not suitable determined by researchers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotech Pharmaceutical Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

lihong liu

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

yanling he

Role: PRINCIPAL_INVESTIGATOR

Beijing Chao Yang Hospital

Locations

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

BT-T1h-PSO-1

Identifier Type: -

Identifier Source: org_study_id