Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001380189
Ethics application status
Approved
Date submitted
18/09/2019
Date registered
10/10/2019
Date last updated
2/03/2021
Date data sharing statement initially provided
10/10/2019
Date results information initially provided
22/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety, Tolerability and Pharmacokinetics of ALD1910
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose
Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of
ALD1910, a Humanized Anti-Pituitary Adenylate Cyclase Activating Peptide
(PACAP) Monoclonal Antibody
Secondary ID [1] 298755 0
ALD1910-CLIN-001
Secondary ID [2] 303568 0
18902A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 313716 0
Condition category
Condition code
Neurological 312125 312125 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Part A includes up to 8 dosing cohorts with 8 subjects in each cohort. Each subject receives one dose of ALD1910 or placebo infused into a vein. The ALD1910 dose level increases for each cohort (1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 300 mg, or 1000 mg) if data from each cohort show it is safe to do so.
Part B includes 2 dosing cohorts with 16 subjects in each cohort. The dose for Part B will be determined based upon the safety data committee review of all doses tested in part A. In one cohort subjects will receive either ALD1910 or placebo infused into a vein. Subjects will also receive 6 mg sumatriptan injected under the skin 2 hours after the end of the ALD1910 or placebo infused into a vein. In the second cohort subjects receive one dose of ALD1910 or placebo injected under the skin. The ALD1910 dose level is one of the doses tested in Part A and will not exceed 100 mg.
Each subject will remain in the study unit until the morning of the 3rd day after dosing (approximately 48 hours post-dose). Subjects will complete 9 additional outpatient visits for safety assessment over 20 weeks.
Intervention code [1] 315221 0
Treatment: Drugs
Comparator / control treatment
Solution formulated with the same excipients as ALD1910 without the active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 320784 0
Safety (e.g., Adverse Events (AE), Serious Adverse Events (SAE), Vital Signs Measurements, Electrocardiogram (ECG) Results, Clinical Laboratory Results)
Possible AEs/SAEs may include hyperglycemia detected and followed with laboratory tests and clinical examination
Timepoint [1] 320784 0
Baseline, Day 1, 2, 3, 5 and Week 2, 3, 4, 6, 8, 10, 12 and 20 after intervention. All safety assessments are completed at all scheduled visits including screening, except for the following:
Physical Exam/Weight: Screening, Week 12, 20
Ophthalmology Exam: Screening, Week 20
Serum pregnancy (hCG) test: Screening, Week 4, 8, 12, 20
HbA1c: Screening, Week 12, 20
Serum Anti-ALD1910 Antibody: Screening, Day 1, Weeks 2, 4, 8, 12, 20
Secondary outcome [1] 372839 0
Pharmacokinetics. Single dose ALD1910 pharmacokinetics are derived from the serum concentration versus time profile relative to the start of dose administration for each subject. Parameters (Peak Concentration (Cmax), Time to the observed maximum concentration (tmax), Area under the concentration-time curve, time zero to the last time point (AUC(0-T)), Area under the concentration-time curve, time of dosing (0 hr) extrapolated to infinity (AUC(INF)), Terminal half-life (T1/2), Clearance (Cl), and Volume of distribution based on the terminal elimination phase (Vz).
Timepoint [1] 372839 0
pre dose, and 30, 60, 90 minutes, 2, 3, 4, 8 hours, 2, 3, 5 days, and 2, 3, 4, 6, 8, 10, 12, 20 weeks after intervention
Secondary outcome [2] 373558 0
Immunogenicity. Development of anti-ALD1910 antibodies (ADA) and characterization of anti-ALD1910 ADA positive responses for neutralizing activity, as determined from serum samples analyzed using validated methods
Timepoint [2] 373558 0
week 2, 4, 8, 12, 20 after intervention

Eligibility
Key inclusion criteria
1. Healthy male or female
2. All female subjects must have a negative pregnancy test result and subjects to use of adequate contraception for the duration of the study.
3. Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100 kg inclusive.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Use of prescription meds, nutritional supplements, OTC medications.
2. New or unusually strenuous exercise for the duration of the trial.
3. Current or previous drug or alcohol abuse.
4. Current, or previous smoker within 12 weeks prior to screening. Causal or social smokers are allowed.
5. Previous treatment or clinical trial with a monoclonal antibody 6 months prior to screening.
6. Current participation in any clinical research study.
7. ECG QTcF greater than or equal to 450 msec.
8. Greater than 6.4% glycosylated hemoglobin (HgbA1c) at screening
9. Fasting blood glucose greater than or equal to 126 mg/dL (7 mmol/L) at screening

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)
Once the participant is confirmed eligible, the participant will be randomised on Day 1 by assigning the randomisation number using a randomisation schedule.
The blinded IP will be dispensed for the participant as per randomisation assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomization schedule will be prepared to randomly allocate the subjects to treatment groups in the appropriate ratio according to the cohort. Randomization will occur in blocks (block sizes will be undisclosed).
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
Completed
Date of first participant enrolment
Anticipated
Actual
10/10/2019
Date of last participant enrolment
Anticipated
Actual
20/03/2020
Date of last data collection
Anticipated
6/08/2020
Actual
19/08/2020
Sample size
Target
96
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 303313 0
Commercial sector/Industry
Name [1] 303313 0
Alder BioPharmaceuticals, Inc.
Country [1] 303313 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Alder BioPharmaceuticals, Inc.
Address
11804 North Creek Parkway South, Bothell WA USA 98011
Country
United States of America
Secondary sponsor category [1] 303335 0
None
Name [1] 303335 0
Address [1] 303335 0
Country [1] 303335 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303847 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 303847 0
The Alfred Hospital
55 Commercial Road
Melbourne Victoria 3004
Ethics committee country [1] 303847 0
Australia
Date submitted for ethics approval [1] 303847 0
07/08/2019
Approval date [1] 303847 0
05/09/2019
Ethics approval number [1] 303847 0
463/19

Summary
Brief summary
This is FIH randomized, double-blind, placebo-controlled study in healthy population. Up to 7 single ascending doses (cohorts 1 to 7) will be studied to determine the safety and tolerability of ALD1910.
Approximately 96 healthy male and female participants are planned for the study, 64 for Part A and 32 for Part B.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95006 0
Dr Jason Lickliter
Address 95006 0
Nucleus Network Pty Ltd
Level 1, 484 St Kilda Road,
Melbourne VIC 3004
Country 95006 0
Australia
Phone 95006 0
+61 3 9076 8906
Fax 95006 0
Email 95006 0
J.Lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 95007 0
Ms Biljana Georgievska
Address 95007 0
Nucleus Network Pty Ltd
Level 1, 484 St Kilda Road,
Melbourne VIC 3004
Country 95007 0
Australia
Phone 95007 0
+61 385939817
Fax 95007 0
Email 95007 0
B.Georgievska@nucleusnetwork.com.au
Contact person for scientific queries
Name 95008 0
Ms Biljana Georgievska
Address 95008 0
Nucleus Network Pty Ltd
Level 1, 484 St Kilda Road,
Melbourne VIC 3004
Country 95008 0
Australia
Phone 95008 0
+61 385939817
Fax 95008 0
Email 95008 0
B.Georgievska@nucleusnetwork.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As this is a Phase 1 study, only aggregate data may be posted/published.


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.