Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001211358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
31/08/2026
Date registered
Help: Date registered
30/09/2026
Date last updated
Help: Date last updated
30/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
30/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and acceptability of an intranasal blank sol-gel administration in healthy adults and individuals diagnosed with schizophrenia.
Scientific title
An open label study to evaluate the tolerability of 14-day self-administration of intranasal Sol-Gel in healthy adults and individuals with schizophrenia.
Additional trial identifiers [1] 318315 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
schizophrenia 343446 0
Condition category
Condition code
Mental Health 339538 339538 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This study aims to assess the tolerability of a novel sol-gel nose to brain delivery system in healthy adults and individuals diagnosed with schizophrenia. The design is a single-centre, two stage, vehicle only study to determine the feasibility and acceptability of long term (14 days) daily administration of intranasal sol-gel in alternating nostril. The blank sol-gel is made of a sodium acetate buffer that becomes a gel when warmed to body temperature. Each day, participants will spray alternating nostril with one spray (140ul) of blank sol-gel (which is one quarter of the volume that was well-tolerated in the Phase 1 trial: ANZCTRN12622001122741).
In the first stage, 10 healthy controls will be recruited. Participants will be trained by the trial nurse after written consent has been received. Participants will self-administer the blank sol-gel using an Aptar Pharma nasal delivery device. The study will progress to stage 2 if the initial tolerability is established. In the second stage, 20 participants with schizophrenia will be included and follow the same protocol as stage one.
Intervention code [1] 335210 0
Treatment: Other
Intervention code [2] 335280 0
Treatment: Devices
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346720 0
Tolerability of daily administration of intranasal blank sol-gel for 14 days in healthy control (stage 1)
Timepoint [1] 346720 0
Base line, day 8 and day 15 post-intervention commencement
Primary outcome [2] 346806 0
Tolerability of daily administration of intranasal blank sol-gel for 14 days in participants with schizophrenia (stage 2)
Timepoint [2] 346806 0
Base line, day 8 and day 15 post-intervention commencement
Secondary outcome [1] 467169 0
Feasibility of daily administration of intranasal blank sol-gel for 14 days in healthy controls (stage 1)
Timepoint [1] 467169 0
Base line, day 8 and day 15 post-intervention commencement
Secondary outcome [2] 467638 0
Feasibility of daily administration of intranasal blank sol-gel for 14 days in participants with schizophrenia (stage 2)
Timepoint [2] 467638 0
Base line, day 8 and day 15 post-intervention commencement

Eligibility
Key inclusion criteria
Stage 1.
1. Aged between 18 and 64 years (inclusive).
2. Agree to use contraception for the duration of the trial (14 days).
3. For female participants, agree to completing a pregnancy test at baseline (Day 1) of the trial.
4. Agree to participate, have capacity to consent and can follow the study instructions and procedures in English.

Stage 2.
1. Aged between 18 and 64 years (inclusive).
2. Diagnosis of schizophrenia or schizoaffective disorder recorded in the medical record confirmed by DSM-V-TR criteria.
3. Agree to use contraception for the duration of the trial (14 days).
4. For female participants, agree to completing a pregnancy test at baseline (Day 1) of the trial.
5. Agree to participate, have capacity to consent and can follow the study instructions and procedures in English.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
1. Medical record of known deformity of the nasal cavity; current symptoms of hay fever, acute or chronic sinusitis or recent (in the past 12 months) history of surgery of the nasal cavity and/or nasopharynx, atrophic rhinitis or a history of any anatomical or medical condition that, per the investigators’ clinical judgment, might impede administration of Sol-Gel.
2. Use of intranasal medication in the 4 weeks prior to dosing.
3. Current symptomatic seasonal allergic rhinitis (hayfever).
4. History of severe allergy or anaphylaxis to any drug, food, toxin or other exposure.
5. CHIMA record of moderate or severe substance abuse defined by the DSM-V criteria within 5 years prior to screening (Stage 2 only).
6. Received treatment with another investigational drug, investigational device, or approved therapy for investigational use within 30 days or 5 half-lives (whichever is longer) prior to dosing; prior participation at any time in non-invasive methodology trials in which no drugs were given is acceptable
7. In the opinion of the investigator, has experienced acute upper respiratory illness including a common cold, within 14 days prior screening or baseline visits.
8. In the opinion of the investigator, has had a major illness or hospitalization within 1 month prior to screening.
9. For female participants, those currently pregnant, or planning to become pregnant or lactating during the study period.
10. Unable to cooperate fully with the requirements of the study protocol, including the schedule of assessments, or likely to be non-compliant with any study requirements based on recent history of non-compliance with treatment.
11. Other unspecified reasons that, in the opinion of the Investigator, make the participant unsuitable for enrolment
12. People who are unable to understand or communicate in English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/10/2026
Actual
Date of last participant enrolment
Anticipated
11/06/2027
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 30129 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 46524 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 322877 0
Hospital
Name [1] 322877 0
Metro South Health Research Support Scheme
Country [1] 322877 0
Australia
Primary sponsor type
Hospital
Name
Metro South Hospital land Health Services
Address
Country
Australia
Secondary sponsor category [1] 325804 0
None
Name [1] 325804 0
Address [1] 325804 0
Country [1] 325804 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321310 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 321310 0
Ethics committee country [1] 321310 0
Australia
Date submitted for ethics approval [1] 321310 0
16/01/2025
Approval date [1] 321310 0
10/02/2025
Ethics approval number [1] 321310 0
HREC/2024/QMS/114076

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 153314 0
Dr George Colgan
Address 153314 0
Metro South Addiction and Mental Health Services, 199 Ipswich Rd, Woolloongabba, QLD 4102
Country 153314 0
Australia
Phone 153314 0
+617 3317 1040
Fax 153314 0
Email 153314 0
[email protected]
Contact person for public queries
Name 153315 0
Professor Dan Siskind
Address 153315 0
Metro South Addiction and Mental Health Services, 199 Ipswich Rd, Woolloongabba, QLD 4102
Country 153315 0
Australia
Phone 153315 0
+617 3317 1040
Fax 153315 0
Email 153315 0
[email protected]
Contact person for scientific queries
Name 153316 0
Professor Dan Siskind
Address 153316 0
Metro South Addiction and Mental Health Services, 199 Ipswich Rd, Woolloongabba, QLD 4102
Country 153316 0
Australia
Phone 153316 0
+617 33171040
Fax 153316 0
Email 153316 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.