HealthyPhase 1NCT04940949
A Study to Evaluate Lu AF90103 in Healthy Men
A Phase 1 study testing Lu AF90103 in people with Healthy, run by H. Lundbeck A/S at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lu AF90103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 May 2021to 23 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Lu AF90103, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF90103Drug
Lu AF90103 - powder for solution for infusion
PlaceboDrug
Placebo - powder for solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| Single Intravenous (IV) Dose of Lu AF90103 | Experimental | Participants will receive a single IV dose of Lu AF90103. Receives: Drug: Lu AF90103 |
| Single IV Dose of Placebo | Placebo comparator | Participants will receive a single IV dose of placebo matching to Lu AF90103. Receives: Drug: Placebo |
| 2 Single IV Doses of Lu AF90103 | Experimental | Participants will receive 2 single IV doses of Lu AF90103 separated by at least 5 days. Receives: Drug: Lu AF90103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events
Measured: From dosing (Day 1) to Day 16
Maximum Observed Concentration (Cmax) of Lu AF90103 and AF88361 in Plasma and Cerebrospinal Fluid (CSF)
Measured: 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
Measured: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Total Clearance (CL) of Lu AF90103 and AF88361
Measured: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Amount of Lu AF90103 and Lu AF88361 Excreted in Urine
Measured: 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).
Measured: From dosing (Day 1) to Day 4 (Part A) and Day 9 (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start26 May 2021
- Primary completion23 Nov 2021
- Study completion23 Nov 2021
Why it stopped: The study was terminated based on new safety data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940949
- Sponsor's protocol ID
- 18907A
- Status last verified
- Mar 2023
- First submitted
- 27 May 2021
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04940949
- Acronym / sponsor ID
- 18907A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated based on new safety data.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 26 May 2021 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Intravenous (IV) Dose of Lu AF90103 | Experimental | Drug: Lu AF90103Participants will receive a single IV dose of Lu AF90103. |
| Single IV Dose of Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single IV dose of placebo matching to Lu AF90103. |
| 2 Single IV Doses of Lu AF90103 | Experimental | Drug: Lu AF90103Participants will receive 2 single IV doses of Lu AF90103 separated by at least 5 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AF90103Lu AF90103 - powder for solution for infusion | Drug | 2 Single IV Doses of Lu AF90103, Single Intravenous (IV) Dose of Lu AF90103 |
| PlaceboPlacebo - powder for solution for infusion | Drug | Single IV Dose of Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From dosing (Day 1) to Day 16
Maximum Observed Concentration (Cmax) of Lu AF90103 and AF88361 in Plasma and Cerebrospinal Fluid (CSF)
Time frame: 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
Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Total Clearance (CL) of Lu AF90103 and AF88361
Time frame: 0 (predose) up to 96 hours postdose on Day 1 to Day 5
Amount of Lu AF90103 and Lu AF88361 Excreted in Urine
Time frame: 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
Time frame: From dosing (Day 1) to Day 4 (Part A) and Day 9 (Part B)
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).
Results and safety
The study was stopped early (reason given: The study was terminated based on new safety data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lu AF90103 in people with Healthy, run by H. Lundbeck A/S at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated based on new safety data.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (time frame: From dosing (Day 1) to Day 16). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.