Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000023651
Ethics application status
Approved
Date submitted
27/12/2022
Date registered
10/01/2023
Date last updated
28/09/2023
Date data sharing statement initially provided
10/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate the Safety of BW-00163 in Healthy and Mild Hypertension Subjects
Scientific title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-00163 in Healthy Subjects and Subjects with Mild Hypertension
Secondary ID [1] 308675 0
BW-00163-1002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 328601 0
Condition category
Condition code
Cardiovascular 325613 325613 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BW-00163
4 Cohorts: 50mg, 150mg, 300mg and 600mg
The duration of administration: single dose
BW-00163 will be administered via subcutaneous injection by registered nurse
The used and/or partially used vials can be disposed of per local practice. If the used and/or partially used vials cannot be disposed of at site, they will be returned, along with the unused vials, to the sponsor or its agent after receipt of written authorization from Sponsor.
Intervention code [1] 325144 0
Treatment: Drugs
Comparator / control treatment
Placebo
Sodium chloride injection (0.9% w/v) will be administered via subcutaneous injection

Placebo Comparator: Placebo - Subject will be administered a single dose of placebo in the double-blind
Control group
Placebo

Outcomes
Primary outcome [1] 333452 0
Primary outcome includes adverse events and changes in laboratory parameters up to 12 weeks post dose, The adverse events and change in laboratory parameters will be assessed by triplicate 12-lead ECG (heart rate, PR interval, QRS interval, QT and QTc interval), physical examination (includes, at a minimum skin, cardiovascular, respiratory, gastrointestinal and neurological systems), vital signs assessed by vital signs monitor (vital signs monitor can simultaneously monitor blood pressure, heart rate, respiratory rate and temperature), blood pressure monitoring and by collection of blood sample for assesment of chemistry and hematology, serology (HIV, HBsAg, HBV and HCV), coagulation and urine sample for urinalysis. Adverse effects will be coded using the latest version of MedDRA, summaries will be based on treatment emergent adverse events and will be evaluated and documented using Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA 2007). The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
Timepoint [1] 333452 0
Day -1, Day1, Day2, Day 3, Day 8, Day 15, Day 22, Day 29,Day 43, Day 57 and Day 85 post-dose
Secondary outcome [1] 417148 0
Adverse events and changes in laboratory parameters up to 24 weeks post dose. The adverse events and change in laboratory parameters will be assessed by triplicate 12-lead ECG (heart rate, PR interval, QRS interval, QT and QTc interval), physical examination (includes, at a minimum,skin, cardiovascular, respiratory, gastrointestinal, and neurological systems), vital signs assessed by vital signs monitor (vital signs monitor can simultaneously monitor blood pressure, heart rate, respiratory rate and temperature), blood pressure monitoring and by collection of blood sample for assesment of chemistry and hematology, serology (HIV, HBsAg, HBV, and HCV), coagulation and urine sample for urinalysis. Adverse effects will be coded using the latest version of MedDRA, summaries will be based on treatment emergent adverse events and will be evaluated and documented using Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA 2007). The safety laboratory data will be summarized by visit and by treatment group, along with changes from baseline.
Timepoint [1] 417148 0
Day -1, Day1, Day2, Day 3, Day 8, Day 15, Day 22, Day 29,Day 43, Day 57, Day 85, Day 127 and Day 169 post-dose
Secondary outcome [2] 417149 0
Pharmacokinetic parameters analysis:
1. Maximum Observed Plasma Concentration (Cmax) and of Potential Metabolites
2. Time to maximum plasma concentration (Tmax)
3. Area Under the Concentration-time Curve (AUC0-48) and of Potential Metabolites
4. Area under the plasma concentration versus time curve from zero to infinity (AUC0-inf)
5. Urine concentration up to 24 hours post a single subcutaneous dose
Timepoint [2] 417149 0
Blood samples collected at 0, 0.5, 1, 2, 4, 8, 12, 24 hrs and days 3 and 8 post-dose.
Urine samples collected at 0, 0-4, 4-12, 12-24 hrs post-dose
Secondary outcome [3] 417150 0
Change in serum Angiotensinogen levels from baseline up to 24 weeks
Timepoint [3] 417150 0
Screening visit, Day -1, Day 1, Day 2, Day 3, Day 8, Day 15, Day 22, Day 29,Day 43, Day 57 ,Day 85, Day 127 and Day 169 post-dose
Secondary outcome [4] 417151 0
Assess serum ADA (Anti-BW-00163 antibody)
Timepoint [4] 417151 0
Day 1( pre-dose ), Day 15 and Day 29 post-dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
72 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/03/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 312909 0
Commercial sector/Industry
Name [1] 312909 0
ARGO BIOPHARMA AUSTRALIA PTY LTD
Country [1] 312909 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ARGO BIOPHARMA AUSTRALIA PTY LTD
Address
Level 5, 63 Pirie Street, Adelaide, SA, 5000
Country
Australia
Secondary sponsor category [1] 314587 0
None
Name [1] 314587 0
Address [1] 314587 0
Country [1] 314587 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312183 0
Bellberry Limited
Ethics committee address [1] 312183 0
123 Glen Osmond Road Eastwood Adelaide South Australia 5063
Ethics committee country [1] 312183 0
Australia
Date submitted for ethics approval [1] 312183 0
23/12/2022
Approval date [1] 312183 0
10/02/2023
Ethics approval number [1] 312183 0

Summary
Brief summary
This is a randomized, double-blind, placebo-controlled, single ascending dose study. Approximately 56 men and women who fulfill the inclusion and exclusion criteria will be enrolled at one or more sites in Australia. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2, and return for outpatient visits through Week 24. In Part A, 8 subjects will be randomized in a 3:1 ratio to receive a single dose of BW-00163 (n=6) or placebo (n=2) on Day 1 in a double-blind fashion. Cohorts 1 to 4 will receive BW-00163 doses of 50, 150, 300, and 600mg, or placebo respectively. In Part B,12 subjects will be randomized in a 2:1 ratio to receive a single dose of BW-00163 (n=8) or placebo (n=4) on Day 1 in a double-blind fashion in each cohort. Cohorts 5 and 6 will receive single dose of BW-00163 300 and 600 mg, or placebo respectively.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123766 0
Dr Michele de Sciscio
Address 123766 0
CMAX Clinical Research Pty Ltd, Level 5, 21-24 North Terrace, Adelaide SA 5000
Country 123766 0
Australia
Phone 123766 0
+61 422 447 902
Fax 123766 0
Email 123766 0
[email protected]
Contact person for public queries
Name 123767 0
Mr Ty Burton
Address 123767 0
ARGO BIOPHARMA AUSTRALIA PTY LTD, Level 5, 63 Pirie Street,Adelaide SA 5000
Country 123767 0
Australia
Phone 123767 0
+61 08 83727900
Fax 123767 0
Email 123767 0
[email protected]
Contact person for scientific queries
Name 123768 0
Mr Ty Burton
Address 123768 0
ARGO BIOPHARMA AUSTRALIA PTY LTD, Level 5, 63 Pirie Street,Adelaide SA 5000
Country 123768 0
Australia
Phone 123768 0
+61 08 83727900
Fax 123768 0
Email 123768 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.