Healthy ParticipantsPhase 1NCT06258720
A Trial Investigating Lu AF82422 in Healthy Chinese and Caucasian Adults
A Phase 1 study testing Lu AF82422 in people with Healthy Participants, run by H. Lundbeck A/S at 1 site in China.
Trial summary
The main goals of this trial are to learn more about a) the safety and tolerability of Lu AF82422 (any new or worsening medical issues the participants have with treatment), b) the immunogenicity of Lu AF82422 (the potential for the drug to trigger an unwanted immune response), and c) the pharmacokinetic parameters of… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Lu AF82422
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2024to 3 Sep 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For Chinese participants only: The participant is Chinese, defined as having four Chinese grandparents.
- For Caucasian participants only: The participant is Caucasian, defined as having four Caucasian grandparents.
- The participant has a Body Mass Index (BMI) ≥19 and ≤26 kilograms per square meter (kg/m2) at the Screening Visit and at the Baseline Visit.
- The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological 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 previously been enrolled in this trial.
- The participant has previously been dosed with Lu AF82422.
- The participant has participated in a clinical trial <30 days prior to the Screening Visit.
- The participant has taken any investigational medicinal product <3 months or <5 half-lives of that product, whichever is longer, prior to administration of the IMP.
- The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
- Other protocol-defined criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomized, Open-label, Parallel-group, Single-dose Trial Investigating the Safety, Immunogenicity, Tolerability, and Pharmacokinetic Properties of Lu AF82422 in Healthy Chinese and Caucasian Participants
The main goals of this trial are to learn more about a) the safety and tolerability of Lu AF82422 (any new or worsening medical issues the participants have with treatment), b) the immunogenicity of Lu AF82422 (the potential for the drug to trigger an unwanted immune response), and c) the pharmacokinetic parameters of Lu AF82422 (how the drug is absorbed, distributed, and processed by the body). During the trial, healthy adult Chinese and Caucasian participants will receive a single dose of Lu AF82422, which will be given as an intravenous infusion.
- Conditions
- Healthy Participants
- Being tested
- Lu AF82422
- Keywords
- Safety, Immunogenicity, Tolerability, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF82422Drug
Lu AF82422 solution for intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Lu AF82422 Dose Level 1 | Experimental | Participants will receive a single intravenous (IV) infusion of Lu AF82422 Receives: Drug: Lu AF82422 |
| Lu AF82422 Dose Level 2 | Experimental | Participants will receive a single IV infusion of Lu AF82422 Receives: Drug: Lu AF82422 |
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 (safety and tolerability)
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters)
Measured: From Day 1 to Day 140
Number of participants with anti-drug antibodies
Measured: From Day 1 to Day 140
Cmax: maximum observed plasma concentration of Lu AF82422
Measured: From Day 1 to Day 140
Tmax: time to maximum observed concentration of Lu AF82422
Measured: From Day 1 to Day 140
AUC0-t: area under the concentration-time curve from zero to time t of Lu AF82422
Measured: From Day 1 to Day 140
AUCinf: area under the concentration-time curve from zero to infinity of Lu AF82422
Measured: From Day 1 to Day 140
AUC%extr: percent extrapolated AUC of total AUC0-inf of Lu AF82422
Measured: From Day 1 to Day 140
AUMC0-inf: area under the first moment concentration-time curve from zero to infinity of Lu AF82422
Measured: From Day 1 to Day 140
t1/2: apparent terminal elimination half-life of Lu AF82422
Measured: From Day 1 to Day 140
MRT: mean residence time of Lu AF82422
Measured: From Day 1 to Day 140
CL: systemic clearance of Lu AF82422
Measured: From Day 1 to Day 140
t1/2eff: effective elimination half-life of Lu AF82422
Measured: From Day 1 to Day 140
Vz: apparent volume of distribution of Lu AF82422
Measured: From Day 1 to Day 140
Vss: steady-state volume of distribution of Lu AF82422
Measured: From Day 1 to Day 140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start18 Mar 2024
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT06258720
- Sponsor's protocol ID
- 19728A
- Status last verified
- Nov 2024
- First submitted
- 6 Feb 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomized, Open-label, Parallel-group, Single-dose Trial Investigating the Safety, Immunogenicity, Tolerability, and Pharmacokinetic Properties of Lu AF82422 in Healthy Chinese and Caucasian Participants
- ClinicalTrials.gov ID
- NCT06258720
- Acronym / sponsor ID
- 19728A
- Conditions
- Healthy Participants
- Keywords
- Safety, Immunogenicity, Tolerability, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 14 Feb 2024 (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 goals of this trial are to learn more about a) the safety and tolerability of Lu AF82422 (any new or worsening medical issues the participants have with treatment), b) the immunogenicity of Lu AF82422 (the potential for the drug to trigger an unwanted immune response), and c) the pharmacokinetic parameters of Lu AF82422 (how the drug is absorbed, distributed, and processed by the body). During the trial, healthy adult Chinese and Caucasian participants will receive a single dose of Lu AF82422, which will be given as an intravenous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lu AF82422 Dose Level 1 | Experimental | Drug: Lu AF82422Participants will receive a single intravenous (IV) infusion of Lu AF82422 |
| Lu AF82422 Dose Level 2 | Experimental | Drug: Lu AF82422Participants will receive a single IV infusion of Lu AF82422 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- For Chinese participants only: The participant is Chinese, defined as having four Chinese grandparents.
- For Caucasian participants only: The participant is Caucasian, defined as having four Caucasian grandparents.
- The participant has a Body Mass Index (BMI) ≥19 and ≤26 kilograms per square meter (kg/m2) at the Screening Visit and at the Baseline Visit.
- The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
Key exclusion criteria (6 listed)
- The participant has previously been enrolled in this trial.
- The participant has previously been dosed with Lu AF82422.
- The participant has participated in a clinical trial <30 days prior to the Screening Visit.
- The participant has taken any investigational medicinal product <3 months or <5 half-lives of that product, whichever is longer, prior to administration of the IMP.
- The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
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 AF82422Lu AF82422 solution for intravenous infusion | Drug | Lu AF82422 Dose Level 1, Lu AF82422 Dose Level 2 |
Primary outcome
Number of participants with treatment-emergent adverse events (safety and tolerability)
Time frame: From Day 1 to Day 140
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, blood closure time and ECG parameters)
Number of participants with anti-drug antibodies
Time frame: From Day 1 to Day 140
Cmax: maximum observed plasma concentration of Lu AF82422
Time frame: From Day 1 to Day 140
Tmax: time to maximum observed concentration of Lu AF82422
Time frame: From Day 1 to Day 140
AUC0-t: area under the concentration-time curve from zero to time t of Lu AF82422
Time frame: From Day 1 to Day 140
AUCinf: area under the concentration-time curve from zero to infinity of Lu AF82422
Time frame: From Day 1 to Day 140
AUC%extr: percent extrapolated AUC of total AUC0-inf of Lu AF82422
Time frame: From Day 1 to Day 140
AUMC0-inf: area under the first moment concentration-time curve from zero to infinity of Lu AF82422
Time frame: From Day 1 to Day 140
t1/2: apparent terminal elimination half-life of Lu AF82422
Time frame: From Day 1 to Day 140
MRT: mean residence time of Lu AF82422
Time frame: From Day 1 to Day 140
CL: systemic clearance of Lu AF82422
Time frame: From Day 1 to Day 140
t1/2eff: effective elimination half-life of Lu AF82422
Time frame: From Day 1 to Day 140
Vz: apparent volume of distribution of Lu AF82422
Time frame: From Day 1 to Day 140
Vss: steady-state volume of distribution of Lu AF82422
Time frame: From Day 1 to Day 140
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 12 Nov 2024.
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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
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 AF82422 in people with Healthy Participants, run by H. Lundbeck A/S at 1 site in China.
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 6 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 12 Nov 2024. 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 China. 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. 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 (safety and tolerability) (time frame: From Day 1 to Day 140). The study lists 14 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 12 Nov 2024.