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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04197349
Other study ID # ALD1910-CLIN-001
Secondary ID 18902A
Status Completed
Phase Phase 1
First received
Last updated
Start date September 24, 2019
Est. completion date August 19, 2020

Study information

Verified date September 2020
Source H. Lundbeck A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date August 19, 2020
Est. primary completion date August 19, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Biological:
ALD1910
Single Dose IV infusion
Sumatriptan
Single dose subcutaneous injection
ALD1910
Single dose subcutaneous injection

Locations

Country Name City State
Australia Nucleus Network Pty Ltd Melbourne

Sponsors (2)

Lead Sponsor Collaborator
H. Lundbeck A/S Alder Biopharmaceuticals, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with treatment-emergent adverse events Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, ECG parameters) From dosing to week 20
Secondary Area under the serum concentration-time curve (AUC(0-T)) From dosing to week 20
Secondary Peak serum concentration (Cmax) From dosing to week 20
Secondary Clearance (Cl) From dosing to week 20
Secondary Immunogenicity Number of anti-ALD1910 antibodies (ADA) and characterization of anti-ALD1910 ADA positive responses for neutralizing activity From dosing to week 20
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