- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04197349
Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman
September 21, 2020 updated by: H. Lundbeck A/S
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
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD1910, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a first-in-humam, randomized, double-blind, placebo-controlled study in a 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.
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Melbourne, Australia
- Nucleus Network Pty Ltd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy male or female
- All female subjects must have a negative pregnancy test result and subjects to use of adequate contraception for the duration of the study.
- Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100 kg inclusive.
Exclusion Criteria:
- Use of prescription meds, nutritional supplements, OTC medications.
- New or unusually strenuous exercise for the duration of the trial.
- Current or previous drug or alcohol abuse.
- Current, or previous smoker within 12 weeks prior to screening. Causal or social smokers are allowed.
- Previous treatment or clinical trial with a monoclonal antibody 6 months prior to screening.
- Current participation in any clinical research study.
- ECG QTcF greater than or equal to 450 msec.
- Greater than 6.4% glycosylated hemoglobin (HgbA1c) at screening
- Fasting blood glucose greater than or equal to 126 mg/dL (7 mmol/L) at screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A Cohort 1-8
ALD1910/Placebo; Single Dose IV infusion on Day 1
|
Single Dose IV infusion
Single dose subcutaneous injection
|
Experimental: Part B Cohort 9
ALD1910/Placebo+Sumatriptan; Single Dose IV infusion on Day 1
|
Single Dose IV infusion
Single dose subcutaneous injection
Single dose subcutaneous injection
|
Experimental: Part B Cohort 10
ALD1910/Placebo; Single dose subcutaneous injection on Day 1
|
Single Dose IV infusion
Single dose subcutaneous injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment-emergent adverse events
Time Frame: From dosing to week 20
|
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, ECG parameters)
|
From dosing to week 20
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area under the serum concentration-time curve (AUC(0-T))
Time Frame: From dosing to week 20
|
From dosing to week 20
|
|
Peak serum concentration (Cmax)
Time Frame: From dosing to week 20
|
From dosing to week 20
|
|
Clearance (Cl)
Time Frame: From dosing to week 20
|
From dosing to week 20
|
|
Immunogenicity
Time Frame: From dosing to week 20
|
Number of anti-ALD1910 antibodies (ADA) and characterization of anti-ALD1910 ADA positive responses for neutralizing activity
|
From dosing to week 20
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2019
Primary Completion (Actual)
August 19, 2020
Study Completion (Actual)
August 19, 2020
Study Registration Dates
First Submitted
December 11, 2019
First Submitted That Met QC Criteria
December 11, 2019
First Posted (Actual)
December 13, 2019
Study Record Updates
Last Update Posted (Actual)
September 23, 2020
Last Update Submitted That Met QC Criteria
September 21, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALD1910-CLIN-001
- 18902A (Other Identifier: H. Lundbeck A/S)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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