Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman

• Sponsor: H. Lundbeck A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04197349
• Collaborator: Alder Biopharmaceuticals, Inc. (Industry)
• Enrollment: 96
• Location: 1
• Arms: 3
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 8.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Biological: ALD1910; Biological: Sumatriptan; Biological: ALD1910	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: Sep 24, 2019
• Actual Primary Completion Date: Aug 19, 2020
• Actual Study Completion Date: Aug 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A Cohort 1-8 ALD1910/Placebo; Single Dose IV infusion on Day 1	Biological: ALD1910; Single Dose IV infusion
Experimental: Part B Cohort 9 ALD1910/Placebo+Sumatriptan; Single Dose IV infusion on Day 1	Biological: ALD1910; Single Dose IV infusion; Biological: Sumatriptan; Single dose subcutaneous injection
Experimental: Part B Cohort 10 ALD1910/Placebo; Single dose subcutaneous injection on Day 1	Biological: ALD1910; Single dose subcutaneous injection

Outcome Measures

Primary Outcome Measures

1. Number of participants with treatment-emergent adverse events [From dosing to week 20]

   Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, ECG parameters)

Secondary Outcome Measures

1. Area under the serum concentration-time curve (AUC(0-T)) [From dosing to week 20]

2. Peak serum concentration (Cmax) [From dosing to week 20]

3. Clearance (Cl) [From dosing to week 20]

4. Immunogenicity [From dosing to week 20]

   Number of anti-ALD1910 antibodies (ADA) and characterization of anti-ALD1910 ADA positive responses for neutralizing activity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nucleus Network Pty Ltd	Melbourne		Australia

Sponsors and Collaborators

• H. Lundbeck A/S
• Alder Biopharmaceuticals, Inc.

Investigators

• Study Director: Email contact via H. Lundbeck A/S, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT04197349
• Other Study ID Numbers: ALD1910-CLIN-001; 18902A
• First Posted: Dec 13, 2019
• Last Update Posted: Sep 23, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sumatriptan

Study Results

No Results Posted as of Sep 23, 2020