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Trial registered on ANZCTR


Registration number
ACTRN12624001338550
Ethics application status
Approved
Date submitted
9/10/2024
Date registered
5/11/2024
Date last updated
5/11/2024
Date data sharing statement initially provided
5/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study of the Safety and Tolerability of SCS1
Scientific title
A Phase 1, Double-blind, Placebo controlled Study of SCS1 in Healthy Participants
Secondary ID [1] 312361 0
SCS1-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
None 334143 0
Condition category
Condition code
Neurological 330817 330817 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary and secondary objectives of the study are to evaluate the safety, tolerability, and pharmacokinetics of a single oral dose of SCS1. Escalating doses will be administered based on participant body weight in each of up to 6 cohorts with scheduled doses of each cohort as follows: cohort 1 = 2 mg/kg, cohort 2 = 8 mg/kg, cohort 3 = 24 mg/kg, cohort 4 = 72 mg/kg, cohort 5 = 160 mg/kg, and cohort 6 = 324 mg/kg of SCS1. Participants will receive study intervention directly from the investigator (or designee), under medical supervision. Escalating dose cohorts will commence only after safety review of the prior cohort (e.g. cohort 2 will commence only after safety review of cohort 1) including review from follow-up visit (on day 7, 8, or 9 relative to the day of dosing). Doses will be administered orally as a liquid.
Intervention code [1] 328866 0
Treatment: Drugs
Comparator / control treatment
Placebo: water (liquid form)
Control group
Placebo

Outcomes
Primary outcome [1] 338593 0
Safety and tolerability of single ascending oral doses of SCS1 in healthy participants. Safety and tolerability are evaluated together as a composite primary outcome.
Timepoint [1] 338593 0
• Timepoint = continuous on Day -1, 1, 2, and 3 (relative to the day of dosing), as well as Day 7, 8, or 9 (relative to the day of dosing) for the following assessments: incidence and severity of adverse events
• Timepoint = Day -1 (relative to the day of dosing), Day 1 (postdose on the day of dosing), Day 2 (relative to the day of dosing), and Day 3 (relative to the day of dosing) for the following assessment: FOBT
• Timepoint = Day -1 (relative to the day of dosing), Day 1 predose (-0.75 hours relative to dosing), Day 2 (24 hours postdose), Day 3 (48 hours postdose), and at follow-up (Day 7, 8, or 9 relative to the day of dosing) for the following assessments: incidence of laboratory abnormalities evaluated by clinical laboratory measures including of chemistries, hematology, urinalysis, and coagulation
• Timepoint = Day -1 (relative to the day of dosing), Day 1 predose (-1.25 hours relative to dosing), Day 1 postdose (2.5 hours and 8 hours postdose), Day 2 (24 hours postdose), Day 3 (48 hours postdose), and at follow-up (Day 7, 8, or 9 relative to the day of dosing) for the following assessments: 12 lead electrocardiogram parameters including heart rate; QRS duration; RR, PR, and QT intervals; QT intervals corrected for heart rate; and QT intervals corrected for heart rate using Fridericia’s formula
• Timepoint = Day -1 (relative to the day of dosing), Day 1 predose (-1.25 hours relative to dosing), Day 1 postdose (50 minutes, 2.5 hours, 4 hours, and 8 hours postdose), Day 2 (24 hours postdose), Day 3 (48 hours postdose), and at follow-up (Day 7, 8, or 9 relative to the day of dosing) for the following assessments: vital signs measurements including tympanic temperature; pulse rate, respiratory rate, oxygen saturation, and blood pressure
• Timepoint = Day 1 predose (-1.25 hours relative to dosing), Day 1 postdose (4 hours and 8 hours postdose), Day 3 (relative to the day of dosing prior to discharge), and at follow-up (Day 7, 8, or 9 relative to the day of dosing) for the following primary assessments: physical examinations including assessments of the cardiovascular, respiratory, gastrointestinal, and neurological systems or as deemed appropriate by the investigator (or designee)
Secondary outcome [1] 436522 0
Pharmacokinetics of single ascending oral doses of SCS1 in healthy participants.
Timepoint [1] 436522 0
Day 1 predose (-0.75 hours relative to dosing), Day 1 postdose (0.75 hours, 1.25 hours, 2.25 hours, 3.25 hours, 6 hours, and 12 hours postdose) and Day 2 (24 hours postdose)

Eligibility
Key inclusion criteria
1. Male or female, of any race, between 18 and 55 years of age.
2. Body mass index between 18.0 and 32.0 kg/m2, inclusive.
3. In good health
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
26/11/2024
Actual
Date of last participant enrolment
Anticipated
20/03/2025
Actual
Date of last data collection
Anticipated
19/04/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316769 0
Commercial sector/Industry
Name [1] 316769 0
Sydney Cove Sciences Pty Ltd
Country [1] 316769 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Sydney Cove Sciences Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319385 0
None
Name [1] 319385 0
Address [1] 319385 0
Country [1] 319385 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315537 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 315537 0
[email protected]
Ethics committee country [1] 315537 0
Australia
Date submitted for ethics approval [1] 315537 0
31/07/2024
Approval date [1] 315537 0
13/09/2024
Ethics approval number [1] 315537 0

Summary
Brief summary
This study is testing the safety and tolerability of a single dose of SCS1 in healthy participants. Approximately 40 participants will be enrolled consecutively across multiple escalating dose cohorts to receive a single oral dose of SCS1 or placebo. Cohorts will proceed following satisfactory review of the prior cohort data (including the safety and tolerability data). Cohorts will be determined by escalations of not more than 5-fold. The study hypothesis is that the doses planned for administration will be safe and well tolerated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135006 0
Dr Ofer Gonen
Address 135006 0
Nucleus Network Pty Ltd, Level 3, 549 St Kilda Road, Melbourne VIC 3004
Country 135006 0
Australia
Phone 135006 0
+61 3 8593 9801
Fax 135006 0
Email 135006 0
[email protected]
Contact person for public queries
Name 135007 0
Nucleus Network Melbourne
Address 135007 0
Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, Victoria, 3004
Country 135007 0
Australia
Phone 135007 0
+61 1800 243 733
Fax 135007 0
Email 135007 0
[email protected]
Contact person for scientific queries
Name 135008 0
Nucleus Network Melbourne
Address 135008 0
Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, Victoria, 3004
Country 135008 0
Australia
Phone 135008 0
+61 1800 243 733
Fax 135008 0
Email 135008 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.