HealthyPhase 1NCT05045781
Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects
A Phase 1 study testing Eptinezumab in people with Healthy, run by H. Lundbeck A/S at 1 site in China.
Trial summary
The purpose of the study is to investigate how the body absorbs and get rid of eptinezumab when given directly into a vein in Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Eptinezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2021to 20 Jul 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI of ≥ 19 and ≤ 25 kg/m2.
- The subject is Chinese, defined as being born in China and having four Chinese grandparents.
- The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
Who cannot join
- The subject is pregnant or breastfeeding.
- The subject 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, Single-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Eptinezumab in Healthy Chinese Subjects
The purpose of the study is to investigate how the body absorbs and get rid of eptinezumab when given directly into a vein in Chinese subjects.
Read the detailed description
This is an interventional, randomized, open-label, parallel-group, single-dose study investigating the safety, tolerability and pharmacokinetic properties of eptinezumab administered by intravenous (iv) infusion.
The study will consist of 20 healthy Chinese subjects, who will be randomized into two single-dose groups. The two groups will be run in parallel. In Group 1, a total of 10 subjects will receive a single iv infusion of 100 mg eptinezumab on Day 1. In Group 2, a total of 10 subjects will receive a single iv infusion of 300 mg eptinezumab on Day 1.
Safety and tolerability will be assessed throughout the study. Blood samples for plasma quantification of free eptinezumab will be collected from Day 1 to the Completion Visit (Day 84)/Withdrawal Visit.
- Conditions
- Healthy
- Being tested
- Eptinezumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EptinezumabDrug
single iv infusion
| Study group | Role | What they receive |
|---|---|---|
| Eptinezumab 100 mg | Experimental | Not described Receives: Drug: Eptinezumab |
| Eptinezumab 300 mg | Experimental | Not described Receives: Drug: Eptinezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-inf) eptinezumab
Area under the plasma concentration-time curve
Measured: Day 1 to Day 84
Maximal observed plasma concentration (Cmax) of eptinezumab
Measured: Day 1 to Day 84
Systemic clearance (CL) of eptinezumab
Eptinezumab dose/AUC(0-inf)
Measured: Day 1 to Day 84
tmax
Nominal time for the occurrence of Cmax (tmax)
Measured: Day 1 to Day 84
Apparent terminal elimination half-life (t½)
Measured: Day 1 to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start20 Apr 2021
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT05045781
- Sponsor's protocol ID
- 19004A
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 16 Sep 2021
- 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 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Single-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Eptinezumab in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT05045781
- Acronym / sponsor ID
- 19004A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 16 Sep 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 the study is to investigate how the body absorbs and get rid of eptinezumab when given directly into a vein in Chinese subjects.
Detailed description
This is an interventional, randomized, open-label, parallel-group, single-dose study investigating the safety, tolerability and pharmacokinetic properties of eptinezumab administered by intravenous (iv) infusion.
The study will consist of 20 healthy Chinese subjects, who will be randomized into two single-dose groups. The two groups will be run in parallel. In Group 1, a total of 10 subjects will receive a single iv infusion of 100 mg eptinezumab on Day 1. In Group 2, a total of 10 subjects will receive a single iv infusion of 300 mg eptinezumab on Day 1.
Safety and tolerability will be assessed throughout the study. Blood samples for plasma quantification of free eptinezumab will be collected from Day 1 to the Completion Visit (Day 84)/Withdrawal Visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eptinezumab 100 mg | Experimental | Drug: Eptinezumab |
| Eptinezumab 300 mg | Experimental | Drug: Eptinezumab |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI of ≥ 19 and ≤ 25 kg/m2.
- The subject is Chinese, defined as being born in China and having four Chinese grandparents.
- The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an ECG, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
Key exclusion criteria (3 listed)
- The subject is pregnant or breastfeeding.
- The subject 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 |
|---|---|---|
| Eptinezumabsingle iv infusion | Drug | Eptinezumab 100 mg, Eptinezumab 300 mg |
Primary outcome
AUC(0-inf) eptinezumab
Time frame: Day 1 to Day 84
Area under the plasma concentration-time curve
Maximal observed plasma concentration (Cmax) of eptinezumab
Time frame: Day 1 to Day 84
Systemic clearance (CL) of eptinezumab
Time frame: Day 1 to Day 84
Eptinezumab dose/AUC(0-inf)
tmax
Time frame: Day 1 to Day 84
Nominal time for the occurrence of Cmax (tmax)
Apparent terminal elimination half-life (t½)
Time frame: Day 1 to Day 84
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 16 Sep 2021.
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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 Eptinezumab in people with Healthy, 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 3 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 16 Sep 2021. 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?
AUC(0-inf) eptinezumab (time frame: Day 1 to Day 84). The study lists 5 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 Sep 2021.