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Trial registered on ANZCTR


Registration number
ACTRN12622001019796
Ethics application status
Not required
Date submitted
12/07/2022
Date registered
21/07/2022
Date last updated
10/12/2023
Date data sharing statement initially provided
21/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
EmtinB Safety, Tolerability and Pharmacokinetics (PK) Study in Healthy Participants
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study Investigating Safety and Tolerability and Pharmacokinetics of Subcutaneously Administered EmtinB in Healthy Adult Volunteers
Secondary ID [1] 307301 0
NSB1528-782-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurodegenerative disorders 326589 0
Condition category
Condition code
Neurological 323834 323834 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EmtinB subcutaneous injection

Experimental: Single Ascending Doses of EmtinB at planned dose levels of 10 mg/30 mg/60 mg/101.25 mg/150 mg administered on a single occasion.
Experimental: Multiple Ascending Doses of EmtinB at planned dose levels of 30 mg/60 mg/101.25 mg/150 mg administered once daily for 7 days. This part will commence following completion of all single dose cohorts. Participants who completed a Single Ascending Dose cohort may not also participate in a Multiple Ascending Dose cohort.

Treatment: Drugs: EmtinB will be administered subcutaneously to the abdomen in single and multiple doses in the clinic by trained, qualified personnel. Each participant may only participate in a single cohort to receive either a single dose, or multiple doses once daily for 7 days.
Intervention code [1] 323746 0
Treatment: Drugs
Comparator / control treatment
Treatment: Drugs - Matched Placebo subcutaneous injection consisting of a saline solution.

Treatment: Drugs: Matched placebo will be administered subcutaneously to the abdomen in single and multiple doses in the same manner as described for the intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 331626 0
Safety of single and multiple escalating doses of EmtinB assessed by occurrence of treatment emergent adverse events recorded through observation and non-leading questioning as well as through specific assessments to objectively assess for clinically significant changes from baseline in: - Laboratory evaluations; - Vital signs (temperature using an electronic probe, manually counted respiratory rate and pulse rate and blood pressure measured using a non-invasive automated blood pressure monitor); - Electrocardiograms; - Physical examinations; - Columbia-Suicide Severity Rating Scale (Multiple Ascending Dose cohorts only).
Timepoint [1] 331626 0
Single Ascending Dose arm: Day 1 to Day 8 (7 days post-dose)
Multiple Ascending Dose arm: Day 1 to Day 14 (7 days post-last dose)
Primary outcome [2] 332055 0
Tolerability of single and multiple escalating doses of EmtinB assessed by:
- Local injection site reactions.
Timepoint [2] 332055 0
Single Ascending Dose arm: Day 1 to Day 8 (7 days post-dose)
Multiple Ascending Dose arm: Day 1 to Day 14 (7 days post-last dose)
Secondary outcome [1] 410575 0
PK of EmtinB following single and multiple ascending doses on plasma samples to assess Cmax, tmax, AUC, t1/2, Kel, CL/F, Vz/f and Css.
Timepoint [1] 410575 0
Single Ascending Dose arm: blood samples collected at pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours post-dose

Multiple Ascending Dose arm: blood samples collected at Day 1 pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24 (pre-Day 2 dose), 48 (pre-Day 3 dose), pre-Day 4 dose, pre-Day 6 dose, then at Day 7 pre-dose, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 30, 36 and 48 hours post-dose.

Eligibility
Key inclusion criteria
1. Generally healthy with the exception of those medical conditions allowed per the inclusion/exclusion criteria.

2. Adult male and female participants aged greater than or equal to 18 and less than or equal to 60 years at the time of screening.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Presence or history of any cardiovascular, gastrointestinal, renal, hepatic, respiratory, hematological, lymphatic, immunological, dermatological, neurological, musculoskeletal, connective tissue, genitourinary, endocrine or psychiatric diseases or disorders, which are determined as clinically relevant by the investigator as they would make implementation of the protocol or interpretation of the study data difficult, or would put the participant at risk by participation in the study in the opinion of the investigator..

2. Any evidence or treatment of malignancy (other than localized basal cell cancer, squamous cell skin cancer, or cancer in situ that has been resected or successfully treated with topical therapy e.g. Aldara) within the previous 5 years.

3. Abnormal ECG, and deemed clinically significant by the investigator, at screening and/or Day -1 defined as; QTcF >450 msec (males) or >470 msec (females).

4. Clinically significant renal disease, nephrectomy, renal transplant or estimated glomerular filtration rate of <90 mL/min/1.73 m^2 at screening based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation 2009.

5. Abnormal vital sign findings (after resting semi-supine for 5 minutes) defined as:
• Blood pressure that is >140 mm Hg or <90mm Hg systolic, or >90 mm Hg or <40 mm Hg diastolic at screening or Day -1.
• Pulse rate that is <40 or >100 bpm at screening or Day -1.

6. Used or are using over-the-counter medications, dietary/nutritional supplements (except for occasional paracetamol, up to 2 g in any 1 day) within 7 days prior to first dose on Day 1 until completion of the EOS visit.

7. Used or are using prescription medications (except stable female contraceptives that must continue uninterrupted for the duration of the study) within 14 days or 5 half-lives prior to first dose on Day 1 (whichever is longer) until completion of the EOS visit.

8. Used or are using systemic steroids (orally or intravenously administered) within 28 days prior to first dose on Day 1 until completion of EOS visit.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Sponsor decision to cease development in the indication
Date of first participant enrolment
Anticipated
7/09/2023
Actual
Date of last participant enrolment
Anticipated
26/03/2024
Actual
Date of last data collection
Anticipated
12/04/2024
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25370 0
Nucleus Network - Melbourne
Recruitment hospital [2] 25371 0
Nucleus Network - Geelong
Recruitment postcode(s) [1] 41099 0
3004 - Melbourne
Recruitment postcode(s) [2] 41100 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 311595 0
Commercial sector/Industry
Name [1] 311595 0
NeuroScientific Biopharmaceuticals Ltd
Country [1] 311595 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
NeuroScientific Biopharmaceuticals Ltd
Address
Suite 5, 85 Forrest Street, Cottesloe WA 6011
Country
Australia
Secondary sponsor category [1] 313032 0
None
Name [1] 313032 0
Address [1] 313032 0
Country [1] 313032 0
Other collaborator category [1] 282328 0
Commercial sector/Industry
Name [1] 282328 0
Nucleus Network Pty Ltd
Address [1] 282328 0
Level 5, 89 Commercial Rd, Melbourne, Victoria 3004
Country [1] 282328 0
Australia
Other collaborator category [2] 282795 0
Commercial sector/Industry
Name [2] 282795 0
Nucleus Network Pty Ltd
Address [2] 282795 0
235 Ryrie Street, Geelong, Victoria 3220
Country [2] 282795 0
Australia

Ethics approval
Ethics application status
Not required

Summary
Brief summary
This is a first-in-human, Phase 1, single-center study that will evaluate single ascending doses (SAD) and multiple ascending doses (MAD) of EmtinB conducted in 2 parts.

Part 1 (SAD) of this study will be conducted in approximately 40 healthy participants in up to 5 groups. Each group will consist of up to 8 participants who will be randomized to receive a single dose of EmtinB or placebo.

Part 2 (MAD) of this study will be conducted in approximately 32 healthy participants in up
to 4 groups and will commence after safety data for the highest dose in the SAD phase has
been evaluated. Each group will consist of up to 8 participants who will be randomized to receive 7 daily doses of EmtinB or placebo.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119790 0
Dr Philip Ryan
Address 119790 0
Nucleus Network Pty Ltd, Level 5, Burnet Tower, 89 Commercial Road, Melbourne, Victoria 3004
Country 119790 0
Australia
Phone 119790 0
+61 3 8593 9800
Fax 119790 0
Email 119790 0
p.ryan@nucleusnetwork.com.au
Contact person for public queries
Name 119791 0
Dr Nucleus Network Melbourne
Address 119791 0
Level 5, Burnet Tower, 89 Commercial Road, Melbourne, Victoria 3004
Country 119791 0
Australia
Phone 119791 0
+61 1800 243 733
Fax 119791 0
Email 119791 0
melbourne@nucleusnetwork.com.au
Contact person for scientific queries
Name 119792 0
Mr Simon Scott
Address 119792 0
NeuroScientific Biopharmaceuticals Ltd
Suite 5, 85 Forrest Street
Cottesloe 6011 WA
Country 119792 0
Australia
Phone 119792 0
+61 8 6382 1805
Fax 119792 0
Email 119792 0
simon@neuroscientific.com

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.