A Study to Evaluate the Safety of BW-00163 in Healthy and Mild Hypertension Subjects

Phase 1

Recruiting

• Conditions: Hypertension; Cardiovascular - Hypertension

• Registration Number: ACTRN12623000023651
• Lead Sponsor: ARGO BIOPHARMA AUSTRALIA PTY LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-10
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

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

Inclusion Criteria

1.Healthy males or females aged 18 to 60 years, inclusive, at the time of informed consent.(Part A only).
2. Males or females aged 18 to 72 years, inclusive, at the time of informed consent (Part B only).
3.Body mass index (BMI) >= 18 and <= 32 kg/m2 and body weight >50 kg (Part A only)..
4.Body mass index (BMI) =18 and =35 kg/m2 and body weight >50 kg (Part B only).
5.Triplicate 12-lead electrocardiogram (ECG) after >5 minutes resting without clinically significant findings at screening and Day -1.

Exclusion Criteria

1. History of hypotension or orthostatic hypotension.
2. History of syncope.
3. SBP <90 mmHg or DBP <60 mm Hg at screening (Part A only).
4. Clinical laboratory findings outside of range are deemed clinically significant by the investigator at screening.
5.History or presence of type 1 or type 2 diabetes mellitus at screening (Fasting blood glucose >7.0 mmol/L or HBA1c >6.5%).
6. Any liver function panel analyte value > 1.2 ×upper limits of normal (ULN) at
screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified