Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000785505p
Ethics application status
Not yet submitted
Date submitted
31/05/2024
Date registered
26/06/2024
Date last updated
26/06/2024
Date data sharing statement initially provided
26/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 Dose Escalation Safety Study of PBI-671 in Subjects with Advanced Glaucoma
Scientific title
A Phase 1 Dose Escalation Safety Study of PBI-671 in Subjects with Advanced Glaucoma
Secondary ID [1] 312258 0
None
Universal Trial Number (UTN)
PPH-GL-001
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 333972 0
Condition category
Condition code
Eye 330640 330640 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single intravitreal dose of either Dose A or Dose B of PBI-671 in one eye by an ophthalmologist. Dose A will be 0.4 mg/eye, Dose B will be 1.0 mg/eye. The first 3 subjects will receive Dose A (with sentinel dosing), the second 3 subjects will receive Dose B (with sentinel dosing). The remaining 7 subjects may be allocated between Doses A and B as per the recommendation of the Safety Review Committee.

Study sites are to follow ophthalmic standards for intravitreal injection preparation and procedure, Ophthalmolost will apply single-use topical anesthetic to the study eye as needed to achieve adequate anesthesia for the procedure. Additional local subconjunctival anesthesia (e.g., 1% lidocaine hydrochloride solution) can be used at the Investigator’s discretion.
Intervention code [1] 328714 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338385 0
Safety
Timepoint [1] 338385 0
Adverse events will be assessed at Day 7, 14, Week 4, 8, and 12 after treatment
Primary outcome [2] 338474 0
Change from baseline in slit lamp assessments
Timepoint [2] 338474 0
Day 7, 14, Week 4, 8, and 12 after treatment. (Note that Baseline assessment will also be conducted prior to treatment.)
Primary outcome [3] 338475 0
Change from baseline in blood labs.
Timepoint [3] 338475 0
12 weeks after treatment. (Note that Baseline assessment will also be conducted prior to treatment.)
Secondary outcome [1] 436075 0
Bioanalysis of soluble drug in aqueous humor
Timepoint [1] 436075 0
Day 7, Week 4, and Week 12 after treatment

Eligibility
Key inclusion criteria
Eligible subjects will have been diagnosed with advanced glaucoma with the following characteristics:
1. Has substantial vision loss, but retains the ability to fixate for Spectral Domain Optical Coherence Tomography (SD-OCT).
2. Is unlikely to substantially benefit from an additional, commercially approved medication for glaucoma in the opinion of the Investigator.
3. Is anticipated to remain on stable ocular drug therapy (other than the study drug), including intraocular pressure (IOP)-lowering medications (as needed), without surgery during the course of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Confounding ophthalmic and systemic diseases, medications, or therapies.
Allergy to study drug or excipient.

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
Other
Other design features
Dose escalation study
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2025
Actual
Date of last data collection
Anticipated
24/12/2025
Actual
Sample size
Target
13
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316639 0
Commercial sector/Industry
Name [1] 316639 0
Perceive Pharma, Inc.
Country [1] 316639 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Perceive Pharma, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 318825 0
Commercial sector/Industry
Name [1] 318825 0
Beyond Drug Development
Address [1] 318825 0
Country [1] 318825 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315422 0
Bellberry Human Research Ethics Committee (Committee Letter TBD)
Ethics committee address [1] 315422 0
https://bellberry.com.au/
Ethics committee country [1] 315422 0
Australia
Date submitted for ethics approval [1] 315422 0
01/07/2024
Approval date [1] 315422 0
Ethics approval number [1] 315422 0

Summary
Brief summary
This is a prospective, open-label, multi-center Phase 1 study to evaluate the safety and tolerability of a single, unilateral intravitreal injection of escalating doses of PBI-671 Gel for Injection (PBI-671) in subjects with advanced glaucoma). Phase 1 follows a standard dose escalation model with two doses to determine the Maximum Tolerated Dose (MTD) of PBI-671 and recommended Phase 2 dose (RP2D). An Extension Cohort of up to 7 subjects dosed at less than or equal to the MTD may also be enrolled in the Phase 1 study, if the Sponsor and Safety Review Committee (SRC) elect to add additional subjects to further characterize dose levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134650 0
Dr Anne Fung
Address 134650 0
Perceive Pharma, Inc., 6000 Shoreline Court, Suite 206 South San Francisco, CA 94080
Country 134650 0
United States of America
Phone 134650 0
+14153775678
Fax 134650 0
Email 134650 0
annef@perceivebio.com
Contact person for public queries
Name 134651 0
Anne Rubin
Address 134651 0
Perceive Pharma, Inc., 6000 Shoreline Court, Suite 206 South San Francisco, CA 94080
Country 134651 0
United States of America
Phone 134651 0
+17074778172
Fax 134651 0
Email 134651 0
anne@perceivebio.com
Contact person for scientific queries
Name 134652 0
Anne Rubin
Address 134652 0
Perceive Pharma, Inc.,, 6000 Shoreline Court, Suite 206 South San Francisco, CA 94080
Country 134652 0
United States of America
Phone 134652 0
+17074778172
Fax 134652 0
Email 134652 0
anne@perceivebio.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Adverse events
When will data be available (start and end dates)?
After regulatory review and approval of the product in a first country (likely after 2030); data will be available for at least 5 years after approval of the product in a first country.
Available to whom?
Case by case basis at discretion of Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Anne Fung, MD.; annef@perceivebio.com)


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.