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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06870240




Registration number
NCT06870240
Ethics application status
Date submitted
5/03/2025
Date registered
25/03/2025
Date last updated
25/03/2025

Titles & IDs
Public title
A Randomised, Double-blind, Placebo-controlled Phase 2a Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONP-002 in Adults With Mild Traumatic Brain Injury
Scientific title
A Randomised, Double-blind, Placebo-controlled Phase 2a Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONP-002 in Adults With Mild Traumatic Brain Injury
Secondary ID [1] 0 0
ONP-002-AU-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Traumatic Brain Injury, Concussion 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Neurosteroid enantiomer

Placebo comparator: 92mg of Hydroxy-propyl beta-cyclodextrin as a spray-dried powder - The placebo is 92mg of Hydroxy-propyl beta-cyclodextrin as a spray-dried powder

Active comparator: ONP-002 treatment - ONP-002 is 8mg API and 92 Hydroxy-propyl beta-cyclodextrin as a spray-dried powder


Treatment: Drugs: Neurosteroid enantiomer
A non-natural synthetic neurosteroid enantiomer considered a new chemical entity
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient symptom reporting
Timepoint [1] 0 0
Days 2, 5, 10 and 30 post-injurt

Eligibility
Key inclusion criteria
7.2.1 Inclusion Criteria

Participants with suspected concussion presenting to the emergency department will be included in the study only if they satisfy all the following criteria:

1. Participant or legal representative is willing and capable of giving written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
2. Adult males and females, 18 to 55 years of age (inclusive) at screening.
3. Body mass index (BMI) = 18.0 and = 35.0 kg/m2, with a body weight (to 1 decimal place) = 50 kg at screening.
4. Must be diagnosed with a mTBI by all the following measures:

* Negative CT scan for acute traumatic lesions
* Elevated Blood Glial fibrillary acidic protein (GFAP) (=22 pg/mL)
* Glasgow Coma Scale (GCS) score >12
* Neurological Signs and Symptoms Checklist with history of loss/altered consciousness
* Neurological PTA, LOC and AOC checklist
5. Must be able to receive 1st dose of study drug within 12 hours of injury.
6. No evidence of bleeding from the nose or visual full occlusion of the nasal cavity after a macroscopic nasal examination.
7. Female patients if of childbearing potential (defined as any female who has experienced menarche and who has not undergone surgical sterilisation and is not postmenopausal):

* Must be known to not be pregnant based on a urine or blood test prior to first dose administration.
* Must not be breastfeeding, lactating or planning pregnancy during the study period.
* Must agree not to become pregnant or donate ova for at least 33 days after last dose of study drug.
* Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception [Section 10.2.3]) from screening until at least 33 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle.
8. Male participants must:

* Agree not to donate sperm from signing the consent form until at least 93 days after the last dose of study drug.
* If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception (defined as use of a condom combined with use of highly effective method of contraception) from signing the consent form until at least 93 days after the last dose of study drug.
* If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, must agree to use a condom from signing the consent form until at least 93 days after the last dose of study drug.
9. Have suitable venous access for blood sampling.
10. The patient must agree to have to give their blood without ownership to the repository for blood biomarker analysis.
11. Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

7.2.2
Minimum age
18 Months
Maximum age
60 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Participants will be excluded from the study if they meet any of the following criteria:

1. History or presence of other significant disorder that at the discretion of the PI or delegate is considered "serious" classifying the participant as "not a good candidate" for the study.
2. Presence of penetrating brain injury.
3. Treatment with an investigational drug in another clinical trial within 60 days or 5 half-lives of the other investigational drug (whichever is longer) prior to the first administration of study drug in this trial.
4. Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.

7.3 Screen Failures Participants who consent to participate in the study but fail to meet the eligibility criteria at any point during the Screening Period and until randomisation are defined as screening failures. The reason for each screening failure will be recorded on the appropriate screening and enrolment log.

7.4 Re-Screening Participants who fail screening are not permitted to be re-screened. 7.5 Participant Withdrawal Criteria

Participants will be advised that they are free to withdraw from the study at any time for any reason or, if necessary, the PI (or delegate) may discontinue a participant from the study to protect the participant's wellbeing. A participant may voluntarily withdraw or be withdrawn from the study for reasons including, but not limited to, the following:

* The need to take medication which may interfere with study measurements;
* Intolerable/unacceptable AEs;
* Noncompliance of the participant with the protocol;
* Pregnancy, as indicated in Section 12.7;
* Withdrawal of consent; or
* If, in the PI's (or delegate's) judgement, it is in the participant's best interest.

The Sponsor will be notified as soon as possible of any participant withdrawals. The date and reasons for withdrawal will be recorded in the eCRF.

Any participant who prematurely discontinues study drug, should have all scheduled assessments performed and attend all scheduled follow-up visits. If a participant withdraws or is withdrawn from the study, an attempt should be made to perform the Early Termination Visit assessments detailed in the Schedule of Assessments (SoA) in Section 1.3.

7.6 Participant Replacement Final confirmation of eligibility will be conducted prior to administration of the first dose of study drug (Day 1).

Automatic replacement of participants is allowed if a participant withdraws or is withdrawn prior to administration of the first dose of study drug.

Participants who withdraw or are withdrawn from the study after administration of the first dose of study drug for reasons other than occurrence of a treatment-related SAE, may be replaced at the discretion of the PI (or delegate) and following consultation with the Sponsor.

Any participants enrolled as replacements will be allocated to the same study treatment (treatment arm) as the participant replaced.

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Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Oragenics, Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06870240