A Study to Compare the Bioequivalence and Safety of JHL1101 and Rituximab in CD20 Positive B Cell Lymphoma Patients

Sponsor
JHL Biotech, Inc.
Study ID
NCT03670888
Phase
PHASE1
Status
Terminated

Conditions

  • B Cell Lymphoma

Eligibility Criteria

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

Interventions

  • JHL1101 — BIOLOGICAL
    100 mg/10 mL solution in a single-use vial
  • Rituximab — BIOLOGICAL
    100 mg/10 mL solution in a single-use vial

Study Details

This is a multicenter, randomized, double-blind, parallel group study to compare the PK, safety, tolerability, immunogenicity and PD of JHL1101 vs Rituxan in subjects with CD20-positive B cell lymphoma. The study duration is 13 weeks. Approximately 128 eligible subjects will be randomized in a 1:1 ratio to receive either JHL1101 (n=64) or Rituxan (n=64). Each subject will receive one intravenous (IV) infusions of the investigational product (IP) at the dose of 375mg/m2 on Day 1. Assessments of PK, safety, tolerability, immunogenicity, PD, and efficacy will be collected over the following 13-week period.

Key Dates

Start date
Nov 16, 2018
Status verified
Jan 2020
Primary completion
Mar 19, 2019
Completion
Mar 19, 2019

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JHL1101
    Single dose IV infusion of 375 mg/m2 of JHL1101
  • Active Comparator: Rituxan
    Single dose IV infusion of 375 mg/m2 of Rituximab

Primary Outcome Measure

AUC0~t [ Time Frame: 91 days ]

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