A Study to Evaluate Lu AF90103 in Healthy Men

NCT ID: NCT04940949

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-26
• Study Completion Date: 2021-11-23

Brief Summary

The purpose of this study is to investigate the safety and tolerability of Lu AF90103 and what the body does to Lu AF90103 after single doses of the drug administered directly into a vein.

Detailed Description

This study is the first-in-human (FIH) study with Lu AF90103. The study is divided in two parts, Part A and Part B.

Part A is an interventional, randomized, double-blind, sequential-group, placebo-controlled, single-ascending dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Lu AF90103 in healthy men.

Part B is an interventional, randomized, double-blind, cross-over study to investigate the safety profile after administration of Lu AF90103 as an infusion at two different rates to healthy young men.

The dosage in Part B is guided by the cohorts in Part A and is a repetition of one of the doses from Part A.

The total study duration per participant from baseline to the end of follow-up will be maximum 11 days in Part A and 16 days in Part B.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single Intravenous (IV) Dose of Lu AF90103

Participants will receive a single IV dose of Lu AF90103.

Group Type: EXPERIMENTAL

Lu AF90103

Intervention Type: DRUG

Lu AF90103 - powder for solution for infusion

Single IV Dose of Placebo

Participants will receive a single IV dose of placebo matching to Lu AF90103.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo - powder for solution for infusion

2 Single IV Doses of Lu AF90103

Participants will receive 2 single IV doses of Lu AF90103 separated by at least 5 days.

Group Type: EXPERIMENTAL

Lu AF90103

Intervention Type: DRUG

Lu AF90103 - powder for solution for infusion

Interventions

Lu AF90103

Lu AF90103 - powder for solution for infusion

Intervention Type: DRUG

Placebo

Placebo - powder for solution for infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The participant is ≥18 and ≤45 years of age at the Screening Visit for Cohorts A1 to A6 (excluding cohort A2b) or ≥55 to ≤65 for participants in the CSF sampling Cohorts A2b and A7.
• The participant has body mass index (BMI) ≥18.5 kilograms (kg)/square meter (m^2) and ≤30 kg/m^2 and body weight ≥60 kilograms (kg) at the Screening Visit and at the Baseline Visit.
• The participant has a normal resting electroencephalogram (EEG) at Screening.
• The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria

• The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

QPS Netherlands B.V.

GZ Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

18907A

Identifier Type: -

Identifier Source: org_study_id