Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001430729p
Ethics application status
Submitted, not yet approved
Date submitted
27/10/2022
Date registered
8/11/2022
Date last updated
22/12/2022
Date data sharing statement initially provided
8/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate BW-00163 in Subjects with Hypertension
Scientific title
A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-00163 in Subjects with Hypertension
Secondary ID [1] 308258 0
BW-00163-1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 328039 0
Condition category
Condition code
Cardiovascular 325096 325096 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] 324716 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] 332909 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] 332909 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] 415079 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] 415079 0
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 [2] 415080 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] 415080 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] 415081 0
Change in serum Angiotensinogen levels from baseline up to 24 weeks
Timepoint [3] 415081 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] 415442 0
Assess serum ADA (Anti-BW-00163 antibody)
Timepoint [4] 415442 0
Day 1( pre-dose ), Day 15 and Day 29 post-dose
Secondary outcome [5] 415445 0
Change in mean systolic blood pressure and diastolic blood pressure via 24-hour ambulatory blood pressure monitoring from baseline to 24 weeks, this will be assessed as a composite outcome
Timepoint [5] 415445 0
Day -1, Day 29, Day 57 ,Day 85 and Day 169 post-dose

Eligibility
Key inclusion criteria
1. Has mild to moderate hypertension with mean sitting systolic blood pressure of > = 140 and < = 160 mmHg without hypertensive medication(s) or after 2-week wash-out of antihypertensive medications.
2. 24-hour Ambulatory blood pressure monitoring mean systolic blood pressure > = 130 mmHg.
3. On a usual diet and salt intake for at least 4 weeks prior to screening with no plans to significantly alter diet or weight over course of study.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any uncontrolled or serious disease or clinically significant abnormality in laboratory parameters which in the judgment of the Investigator might compromise the safety of the subject or integrity of the study, interfere with the subject participation in the trial or compromise the trial objectives
2. History of secondary hypertension including, but not limited to any of the following: renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug induced hypertension
3. History of hypotension or orthostatic hypotension
4. Unstable/underlying known cardiovascular disease
5. A cardiac valve repair, cardiac device implantation, and/or a hospitalization for heart failure within 3 months of screening
6. History or presence of Type 1 or Type 2 diabetes mellitus 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
Not yet recruiting
Date of first participant enrolment
Anticipated
23/01/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 312510 0
Commercial sector/Industry
Name [1] 312510 0
ARGO BIOPHARMA AUSTRALIA PTY LTD
Country [1] 312510 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ARGO BIOPHARMA AUSTRALIA PTY LTD
Address
Level 5, 63 Pirie Street, Adelaide, SA, 5023
Country
Australia
Secondary sponsor category [1] 314099 0
None
Name [1] 314099 0
Address [1] 314099 0
Country [1] 314099 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311846 0
Bellberry Limited
Ethics committee address [1] 311846 0
123 Glen Osmond Road Eastwood Adelaide South Australia 5063
Ethics committee country [1] 311846 0
Australia
Date submitted for ethics approval [1] 311846 0
16/11/2022
Approval date [1] 311846 0
Ethics approval number [1] 311846 0

Summary
Brief summary
This is a randomized, double-blind, placebo-controlled, single ascending dose study. Approximately 48 men and women aged 18 to 70 years who fulfill the inclusion and exclusion criteria will be enrolled at 2 to 3 sites in Australia. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2 after completing the 24-hour post-dose follow-up assessments, and return for outpatient visits through Week 24. The single ascending dose study includes 4 cohorts (50mg, 150mg, 300mg and 600mg) of subjects with mild to moderate hypertension (N = 12 per dose cohort).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122578 0
Dr Michele de Sciscio
Address 122578 0
CMAX Clinical Research Pty Ltd, Level 5, 21-24 North Terrace, Adelaide SA 5000
Country 122578 0
Australia
Phone 122578 0
+61 422 447 902
Fax 122578 0
Email 122578 0
Michele.DeSciscio@sa.gov.au
Contact person for public queries
Name 122579 0
Mr Ty Burton
Address 122579 0
ARGO BIOPHARMA AUSTRALIA PTY LTD, Level 5, 63 Pirie Street,Adelaide SA 5000
Country 122579 0
Australia
Phone 122579 0
+61 08 83727900
Fax 122579 0
Email 122579 0
tburton@adel.bentleys.com.au
Contact person for scientific queries
Name 122580 0
Mr Ty Burton
Address 122580 0
ARGO BIOPHARMA AUSTRALIA PTY LTD, Level 5, 63 Pirie Street,Adelaide SA 5000
Country 122580 0
Australia
Phone 122580 0
+61 08 83727900
Fax 122580 0
Email 122580 0
tburton@adel.bentleys.com.au

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.