Eptinezumab in Healthy Japanese Subjects

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Eptinezumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04336449

18899A

Details and patient eligibility

About

The purpose of this study is to investigate how eptinezumab enters, moves through and exits the body. Safety and tolerability will also be investigated.

Full description

The study will consist of 18 healthy Japanese subjects, divided into two single dose cohorts with 9 subjects in each cohort.

Enrollment: 18 patients

Sex: All

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy Japanese subjects with a BMI of ≥ 18.5 and ≤ 25 kg/m2

Other in- and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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18 participants in 3 patient groups, including a placebo group

Cohort 1 100 mg eptinezumab

Experimental group

Treatment:

Drug: Eptinezumab

Cohort 2 300 mg eptinezumab

Experimental group

Treatment:

Drug: Eptinezumab

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo