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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2021-12-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian Adults

NCT04580654

Healthy Volunteers

COMPLETED PHASE1

A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CC-90006 in Healthy Subjects

NCT02934269

Healthy Volunteers

COMPLETED PHASE1

A Phase 1 Study of Subcutaneous CDX-0159 in Healthy Subjects

NCT05031624

Healthy Subjects

COMPLETED PHASE1

Pharmacokinetic (PK)/Pharmacodynamic (PD), Study of Single-dose Subcutaneous CDP6038 in Healthy Japanese Male Subjects

NCT01262794

Healthy Volunteers

COMPLETED PHASE1

Assessing the Safety and Tolerability of CSL730 in Healthy Caucasian and Japanese Adults

NCT03375606

Healthy

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CSL324 (Low dose)

One low dose of CSL324 administered subcutaneously on Day 1

Group Type EXPERIMENTAL

CSL324

Intervention Type BIOLOGICAL

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

CSL324 (High dose)

One high dose of CSL324 administered subcutaneously on Day 1

Group Type EXPERIMENTAL

CSL324

Intervention Type BIOLOGICAL

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

Placebo

One dose of placebo administered subcutaneously on Day 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sterile solution of CSL324 formulation buffer for injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CSL324

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

Intervention Type BIOLOGICAL

Placebo

Sterile solution of CSL324 formulation buffer for injection

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Recombinant Anti G-CSF Receptor Monoclonal Antibody

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy male or female Japanese or White subjects aged 20 and 55 years, inclusive
* Body weight of at least 45 kg to 100 kg, inclusive
* Body mass index of 18.0 to 32.0 kg/m2, inclusive

Exclusion Criteria

* A clinically significant medical condition, disorder, or disease of any organ system.
* Concurrent diagnosis of malignancy or history of malignancy (except for nonmelanoma skin cancer or cervical carcinoma in situ that has been adequately treated with no evidence of recurrence for at least 3 months before Screening).
* Immunosuppressive conditions and / or currently taking immunosuppressive or immunomodulative therapy.
* Clinically significant abnormalities on physical examination, vital signs, or laboratory assessments, or neutropenia (defined as absolute neutrophil count \< 2.0 × 109/L).
* History of chronic or recurrent infections, clinical signs of active infection and / or fever, current / history of serious infection or hospitalized or received IV antibiotics for an infection in previous 2 months.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes