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

Phase 1

Completed

• Conditions: Migraine
• Interventions: Biological: ALD1910; Biological: Sumatriptan

• Registration Number: NCT04197349
• Lead Sponsor: H. Lundbeck A/S

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.

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 Timeline

• Study Start: 2019-09-24
• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-13
• Primary Completion: 2020-08-19
• Study Completion: 2020-08-19
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-21
• Last Update Posted: 2020-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part B Cohort 9	Sumatriptan	ALD1910/Placebo+Sumatriptan; Single Dose IV infusion on Day 1
Part B Cohort 9	ALD1910	ALD1910/Placebo+Sumatriptan; Single Dose IV infusion on Day 1
Part A Cohort 1-8	ALD1910	ALD1910/Placebo; Single Dose IV infusion on Day 1
Part B Cohort 10	ALD1910	ALD1910/Placebo; Single dose subcutaneous injection on Day 1

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Area under the serum concentration-time curve (AUC(0-T))	From dosing to week 20
Peak serum concentration (Cmax)	From dosing to week 20
Clearance (Cl)	From dosing to week 20
Immunogenicity	From dosing to week 20	Number of anti-ALD1910 antibodies (ADA) and characterization of anti-ALD1910 ADA positive responses for neutralizing activity

Trial Locations

Locations (1)

Nucleus Network Pty Ltd; 🇦🇺 Melbourne, Australia