NCT02649270

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

Single and Multiple Dose -Based Tolerability, Safety and Pharmacokinetic Phase 1 Study of Humanized Anti-CD6 Monoclonal Antibody Injection in Chinese Patients With Psoriasis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Biotech Pharmaceutical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-06-01
• Completion: 2017-10-01
• First posted: 2016-01-07
• Last updated: 2023-04-27

Locations

1 site across 1 country: China