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

NCT02649270 | Terminated Phase 1 DMC

• 1 other identifier: BT-T1h-PSO-1
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Tolerability; Safety; Pharmacokinetic Study; preliminary pharmacodynamic study; Humanized Anti-CD6 Monoclonal Antibody(T1h)

Outcome Measures

Primary Outcomes (1)

• Adverse events

  from patients with informed consents to 30 days after the last administration

Secondary Outcomes (26)

• single-dose ,Peak plasma concentration (Cmax) of T1h

  -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration

• single-dose, Area under the plasma concentration versus time curve( AUC(0-t)) of T1h

  -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration

• single-dose, Area under the plasma concentration versus time curve(AUC(0-∞))of T1h

  -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration

• single-dose, Time to peak(Tmax) of T1h

  -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration

• single-dose,Elimination rate constant （kel）of T1h

  -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration

Study Arms (4)

Group1

EXPERIMENTAL

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

Biological: T1h

Group2

EXPERIMENTAL

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

Biological: T1h

Group3

EXPERIMENTAL

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

Biological: T1h

Group4

EXPERIMENTAL

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

Biological: T1h

Interventions

T1h BIOLOGICAL

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

Also known as: Anti-CD6 Monoclonal Antibody

Group1; Group2; Group3; Group4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ranged from 18 to 55 years, males or females ( no less than 3 patients in each dose group)
• Patients with chronic plaque psoriasis for at least 6 months (until patients with an informed consent) with or without arthritis psoriasis
• BSA≥3% or PASI≥10
• PGA≥3
• Patients were eligible if wash-out period was no less than the time as follows:
• weeks for topical retinoic acid or glucocorticoid therapy
• months for retinoic acid of this kind drugs therapy
• weeks for light therapy
• weeks for Psoralen combined with UV-A therapy
• weeks for methotrexate(MTX),cyclophosphamide,cyclosporine and other immunosuppressive therapy
• half life time periods for other systemic immunosuppressive therapy
• weeks for Biological agents for psoriasis therapy
• Fertile males or females who are willing to adopt contraceptive methods (e.g. hormonal pitch, intrauterine device, condoms)
• Patients were voluntary to sign a written informed consent.

You may not qualify if:

• The females were pregnant, or lactating or showed positive urine pregnancy reaction during screening.
• Patients with erythroderma or pustular psoriasis.
• Patients receiving glucocorticoid systemic drug therapy.
• 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
• Patients with any active infection (nail bed induced fungal infections were excluded), chronic infections, and tuberculosis history.
• Patients with severe heart disease, heart failure, asthma, chronic obstructive pulmonary disease or neuropsychiatric diseases.
• Patients previously or currently suffered from tumors including solid tumors, hematologic malignancies and carcinoma in situ.
• Patients with positive tests for hepatitis B surface antigen (HBsAg), hepatitis C serology (HCV-Ab) or human immunodeficiency virus (HIV-Ab)
• 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
• 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.
• Patients with a history of drug abuse or alcoholism
• Patients were allergic to a recombinant biologic agent or any component of proteins derived from murine
• Patients with surgery within three months or any planned surgery or laser skin treatment within six months
• Patients received any vaccination within 28 days
• Patients received any experimental drug treatment within three months

Sponsors & Collaborators

• Biotech Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, 100020, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

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

Study Officials

• lihong liu

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

• yanling he

  Beijing Chao Yang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: January 7, 2016
• Study Start: October 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2017
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

CN (1)