Dose escalation, placebo-controlled phase 1 study to assess the safety and tolerability of CSL324 in healthy adults

Phase 1

Completed

• Conditions: Inflammatory and immune system disorders; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12616000846426
• Lead Sponsor: CSL Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-29
• Study Completion: 2018-01-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Healthy, male or female, 18 to 55 years of age
- Body mass index range of 18.5 to 32.0 kg/m^2, inclusive, and weight at least 50 kg and less than 100 kg
- Females must be of non-childbearing potential
- Male subject and their female spouse/partners who are of childbearing potential must be using 2 forms of highly effective birth control

Exclusion Criteria

- History or evidence of any clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy
- History of venous thrombosis, polycythaemia or thrombophilia
- History of autoimmune disease with the exception of seasonal allergic rhinitis managed without systemic glucocorticoid treatment
- Any history of cyclic neutropenia or a Screening absolute neutrophil count < 2.0 × 10^9/

Study & Design

• Study Type: Interventional
• Study Design: Not specified