A Study to Evaluate Lu AF90103 in Healthy Men

Interventional, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study Part Investigating the Safety, Tolerability, and Pharmacokinetic and -Dynamic Properties of Lu AF90103 and a Double-Blind, Cross-Over Study Part Investigating the Safety Profile After Infusion of Lu AF90103 at Two Rates to Healthy Men

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.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: Lu AF90103; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • GZ Groningen, Netherlands, 9713
    • QPS Netherlands B.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Other inclusion and exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Intravenous (IV) Dose of Lu AF90103; Participants will receive a single IV dose of Lu AF90103.	Drug: Lu AF90103; Lu AF90103 - powder for solution for infusion
Placebo Comparator: Single IV Dose of Placebo; Participants will receive a single IV dose of placebo matching to Lu AF90103.	Drug: Placebo; Placebo - powder for solution for infusion
Experimental: 2 Single IV Doses of Lu AF90103; Participants will receive 2 single IV doses of Lu AF90103 separated by at least 5 days.	Drug: Lu AF90103; Lu AF90103 - powder for solution for infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-Emergent Adverse Events		From dosing (Day 1) to Day 16
Maximum Observed Concentration (Cmax) of Lu AF90103 and AF88361 in Plasma and Cerebrospinal Fluid (CSF)		0 (predose) up to 96 hours postdose on Day 1 to Day 5
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Lu AF90103 and AF88361 in Plasma and CSF		0 (predose) up to 96 hours postdose on Day 1 to Day 5
Total Clearance (CL) of Lu AF90103 and AF88361		0 (predose) up to 96 hours postdose on Day 1 to Day 5
Amount of Lu AF90103 and Lu AF88361 Excreted in Urine		0 (predose) up to 96 hours postdose on Day 1 to Day 5
Changes to Time Matched Baseline in Area Under the Curve (AUC) of Medial Prefrontal (FZ and CZ Electrodes) High Frequency Gamma Signal (100-170 Hertz [HZ]) for Lu AF90103 at the Resting State	The AUC of medial prefrontal (FZ and CZ electrodes) high frequency gamma signal (100-170 HZ) will be derived for Lu AF90103 at resting state, as measured by electroencephalogram (EEG).	From dosing (Day 1) to Day 4 (Part A) and Day 9 (Part B)

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Actual): November 23, 2021
• Study Completion (Actual): November 23, 2021

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 18907A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No