Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001129572p
Ethics application status
Submitted, not yet approved
Date submitted
26/08/2024
Date registered
18/09/2024
Date last updated
18/09/2024
Date data sharing statement initially provided
18/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating Multiple Doses of an Optimized Subcutaneous Formulation of BHV-1300 in a Phase 1, Randomized, Open-Label, Placebo-Controlled Study
Scientific title
Evaluating Multiple Doses of an Optimized Subcutaneous Formulation of BHV-1300 in Healthy Adults in a Phase 1, Randomized, Open-Label, Placebo-Controlled Study
Secondary ID [1] 312677 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autoimmune diseases 334665 0
Condition category
Condition code
Inflammatory and Immune System 331237 331237 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BHV-1300 or placebo dosed once weekly for 4 doses.
500 mg of BHV-1300 will be administered as a subcutaneous injection. The dose will be administered while as an inpatient at the clinic by delegated study site personnel and documented in study notes.

Intervention code [1] 329204 0
Treatment: Drugs
Comparator / control treatment
The placebo to match BHV-1300 in appearance will be normal saline.
Control group
Placebo

Outcomes
Primary outcome [1] 339008 0
To assess the safety and tolerability of BHV-1300 following multiple dose SC administration. Safety and tolerability will be assessed as a composite primary outcome.
Timepoint [1] 339008 0
AE's will be assessed daily from Screening through Day 26 and then on clinic visits on Day 36, Day 50, Day 64 and End of Treatment post-intervention commencement.
Vital signs will be assessed predose on Day 1, post dose on Days 2, 3, 4, 5, 6, and 7, predose on Day 8, post dose on on Days 9, 10, 11, 12, 13, and 14, predose on Day 15, postdose on on Days 16, 17, 18, 19, 20, and 21 and predose on Day 22 and postdose on Days 23, 24, 25, 26, 36, 50, and 64 and End of treatment clinic visit. Vital signs consist of blood pressure, heart rate, respiratory rate and temperature. These will be measured by sphygmomanometer, pulse oximeter and thermometer.
Secondary outcome [1] 438266 0
To characterize the PK profile of BHV-1300 following multiple dose SC administration
Timepoint [1] 438266 0
- Day 1: AUC (0-t), AUC (0-inf), Cmax, Tmax, and T½
- Day 22: AUC (0- t), AUC (0-inf), Cmax, Tmax, T½, RAAUC (0-t), and RACmax

Eligibility
Key inclusion criteria
1. Male or non-childbearing potential female, non-users of tobacco or nicotine products within 3 months prior to Screening, 18 to 55 years of age (inclusive), with BMI 18.0 to 30.0 kg/m2 (inclusive).
2. Healthy as defined by:
a. The absence of clinically significant illness and surgery within 12 weeks prior to dosing.
b. The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, hepatobiliary, renal, and metabolic disease.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of a clinically significant bacterial, fungal, parasitic, viral, or mycobacterial infection within 90 days prior to screening.
2. History of recurrent respiratory tract infections (including bronchitis, viral or bacterial pneumonia, sinusitis).

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)
Allocation is not concealed. Participants will be randomized to receive BHV-1300 or Placebo according to the randomisation schedule prepared prior to study start.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be performed by simple randomisation using a randomisation table created by computer software.
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
28/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317111 0
Commercial sector/Industry
Name [1] 317111 0
Biohaven Therapeutics Limited
Country [1] 317111 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Biohaven Therapeutics Limited
Address
Country
United States of America
Secondary sponsor category [1] 319369 0
Commercial sector/Industry
Name [1] 319369 0
Avance Clinical Pty Ltd
Address [1] 319369 0
Country [1] 319369 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315860 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 315860 0
Ethics committee country [1] 315860 0
Australia
Date submitted for ethics approval [1] 315860 0
04/09/2024
Approval date [1] 315860 0
Ethics approval number [1] 315860 0

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

Contacts
Principal investigator
Name 136018 0
Dr Sam Francis
Address 136018 0
Nucleus Network Pty Ltd, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, VIC 3004
Country 136018 0
Australia
Phone 136018 0
+61 385939800
Fax 136018 0
Email 136018 0
[email protected]
Contact person for public queries
Name 136019 0
Sam Francis
Address 136019 0
Nucleus Network Pty Ltd, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, VIC 3004
Country 136019 0
Australia
Phone 136019 0
+61 385939800
Fax 136019 0
Email 136019 0
[email protected]
Contact person for scientific queries
Name 136020 0
Sam Francis
Address 136020 0
Nucleus Network Pty Ltd, Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, VIC 3004
Country 136020 0
Australia
Phone 136020 0
+61 385939800
Fax 136020 0
Email 136020 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.