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Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects

NCT04570267 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-10-04

No results posted yet for this study

Summary

Study CSL324\_1003 is a single center, randomized, double-blind, placebo-controlled study designed to characterize and compare the PK properties and safety of a single subcutaneous dose of CSL324 in healthy Japanese and White subjects.

Conditions

  • Healthy

Interventions

BIOLOGICAL

CSL324

Sterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection

DRUG

Placebo

Sterile solution of CSL324 formulation buffer for injection

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Study Director · CSL Behring

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2021-11-17
Completion
2021-12-09

Countries

  • Australia

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 NCT04570267 on ClinicalTrials.gov