Pharmacokinetics, Efficacy and Safety of the 304 Injection

Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study ID
NCT03980379
Phase
PHASE1
Status
Unknown

Conditions

  • CD20 Positive B Cell NHL

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 304 injection — DRUG
    Monoclonal antibodies, 100mg/10ml per injection
  • rituximab injection — DRUG
    100mg/10ml per injection ，manufactured by Roche

Study Details

The purpose of this study is to evaluate the pharmacokinetic of the experimental drug 304 injection compared with rituximab injection in patients with CD20 positive B-cell non-Hodgkin lymphoma who had previously achieved CR/CRu status but had not deteriorated or relapsed. While to assess the safety and efficacy of the experimental drug 304 injection compared with rituximab injection.

Key Dates

Start date
Dec 18, 2018
Status verified
May 2019
Primary completion
Jun 30, 2019
Completion
Oct 31, 2019

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: experimental group
    304 injection.WILL be administered single dose IV in the patients with CD20 positive B cell NHL
  • Active Comparator: control group
    Rituximab will be administered single dose IV in the patients with CD20 positive B cell NHL.

Primary Outcome Measure

AUC [0-t] [ Time Frame: For 85 days ]

Central Contacts