Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04197349




Registration number
NCT04197349
Ethics application status
Date submitted
11/12/2019
Date registered
13/12/2019
Date last updated
23/09/2020

Titles & IDs
Public title
Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman
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] 0 0
18902A
Secondary ID [2] 0 0
ALD1910-CLIN-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Migraine 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - ALD1910
Treatment: Other - Sumatriptan
Treatment: Other - ALD1910

Experimental: Part A Cohort 1-8 - ALD1910/Placebo; Single Dose IV infusion on Day 1

Experimental: Part B Cohort 9 - ALD1910/Placebo+Sumatriptan; Single Dose IV infusion on Day 1

Experimental: Part B Cohort 10 - ALD1910/Placebo; Single dose subcutaneous injection on Day 1


Treatment: Other: ALD1910
Single Dose IV infusion

Treatment: Other: Sumatriptan
Single dose subcutaneous injection

Treatment: Other: ALD1910
Single dose subcutaneous injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-emergent adverse events
Timepoint [1] 0 0
From dosing to week 20
Secondary outcome [1] 0 0
Area under the serum concentration-time curve (AUC(0-T))
Timepoint [1] 0 0
From dosing to week 20
Secondary outcome [2] 0 0
Peak serum concentration (Cmax)
Timepoint [2] 0 0
From dosing to week 20
Secondary outcome [3] 0 0
Clearance (Cl)
Timepoint [3] 0 0
From dosing to week 20
Secondary outcome [4] 0 0
Immunogenicity
Timepoint [4] 0 0
From dosing to week 20

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)
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 analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/08/2020
Sample size
Target
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
H. Lundbeck A/S
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Alder Biopharmaceuticals, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Email contact via H. Lundbeck A/S
Address 0 0
[email protected]
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/NCT04197349