A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BW-20805 in Healthy Subjects

Phase 1

Recruiting

• Conditions: Hereditary angioedema; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders

• Registration Number: ACTRN12623000689673
• Lead Sponsor: Argo Biopharma Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-26
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Must have given written informed consent and be able to comply with all study requirements.
2. Males or females aged 18 to 60 aged years, inclusive, at the time of informed consent.
3. BMI (more than equal to) 18 and (less than equal to) 32 kg/m2 with body weight >50 kg.

Exclusion Criteria

1. Any clinically significant chronic medical condition or clinically significant abnormality
in laboratory parameters that, in the opinion of the investigator, makes the subject
unsuitable for participation in the study.
2. Hospitalization for any reason within 60 days prior to screening.
3. Any clinically significant acute condition such as fever (>38 degree centigrade) or acute respiratory illness within 7 days of study drug administration.
4. Systolic blood pressure (more than equal to) 140 mmHg and/or diastolic blood pressure (more than equal to) 90 mmHg after at least 5 minutes resting (seated or supine) at screening and Day -1.
5. Any liver function panel analyte value greater than upper limits of normal (ULN) which
includes aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin
(TBIL), and alkaline phosphatase (ALP) at screening and Day -1.
6. International normalized ratio (INR) above 1.2 × ULN at screening and Day -1.
7. Triplicate 12-lead electrocardiogram (ECG) with clinically significant abnormalities at
screening and Day -1, as determined by the clinical investigator.
8. History or clinical evidence of alcohol abuse, within the 12 months before screening.
9. History or clinical evidence of drug abuse, within the 12 months before screening.
10. Donated or lost >200 mL of blood within 30 days prior to screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified