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A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers

NCT03576651 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2020-01-07

No results posted yet for this study

Summary

This is a Phase I, Double-blind, Randomized, Parallel-group, Single-dose, Three-Arm Study to Compare the Pharmacokinetics and to Evaluate the Tolerability, Safety and Immunogenicity of JHL1149 and Bevacizumab (Avastin) Sourced from the European Union (EU) and the Union States (US) in Healthy Male Volunteers

Conditions

  • Healthy Male Subjects

Interventions

BIOLOGICAL

JHL1149

Each patient may receive single dose of JHL1149 1mg/kg by intravenous infusion

BIOLOGICAL

Bevacizumab

Each patient may receive single dose of Avastin 1mg/kg by intravenous infusion

BIOLOGICAL

Bevacizumab

Each patient may receive single dose of Avastin 1mg/kg by intravenous infusion

Sponsors & Collaborators

  • JHL Biotech, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-24
Primary Completion
2018-09-17
Completion
2019-12-13

Countries

  • Bulgaria

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03576651 on ClinicalTrials.gov