Healthy ParticipantsPhase 1NCT05136053
A Study Investigating Lu AG22515 in Healthy Adults
A Phase 1 study testing Lu AG22515 and Immune System Activator in people with Healthy Participants, run by H. Lundbeck A/S at 2 sites in United States.
Trial summary
The main goal of this study is to learn more about the safety of a drug called Lu AG22515. During the trial, healthy adult participants will receive a single dose of Lu AG22515 or a placebo (normal saline solution). Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Lu AG22515 and Immune System Activator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Mar 2022to 5 Aug 2023
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) ≥18.0 and ≤32.0 kilograms (kg)/square meter (m^2) and weight between 55 and 110 kg (both inclusive) at screening.
- Fully vaccinated against COVID-19, as evidenced by presentation of a vaccine card. The last administration of the COVID-19 vaccination must be received a minimum of 30 days and maximum 6 month prior to dosing in this study.
- Medically healthy with no clinically significant medical history, physical examination and neurological assessment, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.
- Part C only:
- The participant is Japanese, defined as being born in Japan and having four Japanese grandparents as well as living a Japanese lifestyle as confirmed by the Japanese lifestyle questionnaire.
Who cannot join
- Reported history of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- Received any vaccination in the last 30 days prior to Day 1.
- Note: Other inclusion and exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CenExel CNS
Long Beach, California, 90806
Frontage Clinical Research Inc
Secaucus, New Jersey, 07094
About this study
Official title: A Phase 1, 3-Part, Single Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Lu AG22515 (APB-A1) in Healthy Adult Subjects
The main goal of this study is to learn more about the safety of a drug called Lu AG22515. During the trial, healthy adult participants will receive a single dose of Lu AG22515 or a placebo (normal saline solution).
- Conditions
- Healthy Participants
- Being tested
- Lu AG22515, Placebo, Immune System Activator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AG22515Drug
Also called APB-A1
sterile solution for infusion
PlaceboDrug
sterile solution for infusion
Immune System ActivatorDrug
sterile powder for injection
| Study group | Role | What they receive |
|---|---|---|
| Part A: Lu AG22515 | Experimental | Participants will receive a single intravenous (IV) infusion of Lu AG22515. Receives: Drug: Lu AG22515 |
| Part A: Placebo | Placebo comparator | Participants will receive a single IV infusion of placebo matching to Lu AG22515. Receives: Drug: Placebo |
| Part B: Lu AG22515 and Immune System Activator | Experimental | Participants will receive a single IV infusion of Lu AG22515 and a subcutaneous (SC) injection of immune system activator 14 days prior to and 14 days following the start of Lu AG22515 IV infusion. Receives: Drug: Lu AG22515; Drug: Immune System Activator |
| Part B: Placebo and Immune System Activator | Placebo comparator | Participants will receive a single IV infusion of placebo matching to Lu AG22515 and an SC injection of immune system activator 14 days prior to and 14 days following the start of placebo IV infusion. Receives: Drug: Placebo; Drug: Immune System Activator |
| Part C: Lu AG22515 | Experimental | Participants will receive a single intravenous (IV) infusion of Lu AG22515. Receives: Drug: Lu AG22515 |
| Part C: Placebo | Placebo comparator | Participants will receive a single IV infusion of placebo matching to Lu AG22515. Receives: Drug: Placebo |
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 (TEAEs)
Measured: From the day of study drug administration (Day 1) up to end of study (Day 113)
Secondary outcomes (8)
Number of Participants With Anti-Drug Antibodies (ADAs)
Measured: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Area Under the Concentration-Time Curve From Time 0 to Extrapolated to Infinity (AUC0-inf) of Lu AG22515
Measured: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Maximum Observed Plasma Concentration (Cmax) of Lu AG22515
Measured: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Time to Reach Cmax (Tmax) of Lu AG22515
Measured: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Apparent Elimination Half-life (t1/2) of Lu AG22515
Measured: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Apparent Total Serum Clearance (CL) of Lu AG22515
Measured: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Volume of Distribution During the Terminal Elimination Phase (Vz) After IV Administration of Lu AG22515
Measured: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Mean Residence Time (MRT) of Lu AG22515
Measured: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start18 Mar 2022
- Primary completion5 Aug 2023
- Study completion5 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 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, H. Lundbeck A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136053
- Sponsor's protocol ID
- 20119A
- Other IDs
- APB-A1-101
- Status last verified
- Aug 2023
- First submitted
- 13 Oct 2021
- Last updated
- 28 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 3-Part, Single Ascending Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Lu AG22515 (APB-A1) in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05136053
- Acronym / sponsor ID
- 20119A
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 5 Aug 2023 (actual)
- First posted
- 26 Nov 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 main goal of this study is to learn more about the safety of a drug called Lu AG22515. During the trial, healthy adult participants will receive a single dose of Lu AG22515 or a placebo (normal saline solution).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A: Lu AG22515 | Experimental | Drug: Lu AG22515Participants will receive a single intravenous (IV) infusion of Lu AG22515. |
| Part A: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single IV infusion of placebo matching to Lu AG22515. |
| Part B: Lu AG22515 and Immune System Activator | Experimental | Drug: Lu AG22515, Drug: Immune System ActivatorParticipants will receive a single IV infusion of Lu AG22515 and a subcutaneous (SC) injection of immune system activator 14 days prior to and 14 days following the start of Lu AG22515 IV infusion. |
| Part B: Placebo and Immune System Activator | Placebo comparator | Drug: Placebo, Drug: Immune System ActivatorParticipants will receive a single IV infusion of placebo matching to Lu AG22515 and an SC injection of immune system activator 14 days prior to and 14 days following the start of placebo IV infusion. |
| Part C: Lu AG22515 | Experimental | Drug: Lu AG22515Participants will receive a single intravenous (IV) infusion of Lu AG22515. |
| Part C: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single IV infusion of placebo matching to Lu AG22515. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) ≥18.0 and ≤32.0 kilograms (kg)/square meter (m^2) and weight between 55 and 110 kg (both inclusive) at screening.
- Fully vaccinated against COVID-19, as evidenced by presentation of a vaccine card. The last administration of the COVID-19 vaccination must be received a minimum of 30 days and maximum 6 month prior to dosing in this study.
- Medically healthy with no clinically significant medical history, physical examination and neurological assessment, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed by the principal investigator (PI) or designee.
- The participant is Japanese, defined as being born in Japan and having four Japanese grandparents as well as living a Japanese lifestyle as confirmed by the Japanese lifestyle questionnaire.
Key exclusion criteria (3 listed)
- Reported history of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- Received any vaccination in the last 30 days prior to Day 1.
- Note: 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 AG22515Also: APB-A1sterile solution for infusion | Drug | Part A: Lu AG22515, Part B: Lu AG22515 and Immune System Activator, Part C: Lu AG22515 |
| Placebosterile solution for infusion | Drug | Part A: Placebo, Part B: Placebo and Immune System Activator, Part C: Placebo |
| Immune System Activatorsterile powder for injection | Drug | Part B: Lu AG22515 and Immune System Activator, Part B: Placebo and Immune System Activator |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the day of study drug administration (Day 1) up to end of study (Day 113)
8 secondary outcomes
Number of Participants With Anti-Drug Antibodies (ADAs)
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Area Under the Concentration-Time Curve From Time 0 to Extrapolated to Infinity (AUC0-inf) of Lu AG22515
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Maximum Observed Plasma Concentration (Cmax) of Lu AG22515
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Time to Reach Cmax (Tmax) of Lu AG22515
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Apparent Elimination Half-life (t1/2) of Lu AG22515
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Apparent Total Serum Clearance (CL) of Lu AG22515
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Volume of Distribution During the Terminal Elimination Phase (Vz) After IV Administration of Lu AG22515
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Mean Residence Time (MRT) of Lu AG22515
Time frame: Day 1 (within 2 hours prior to the start of infusion) up to end of study (Day 113)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 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
H. Lundbeck A/S
2 sites 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 AG22515 and Immune System Activator in people with Healthy Participants, run by H. Lundbeck A/S at 2 sites in United States.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (TEAEs) (time frame: From the day of study drug administration (Day 1) up to end of study (Day 113)). 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 28 Aug 2023.