HealthyPhase 1NCT04336449
Eptinezumab in Healthy Japanese Subjects
A Phase 1 study testing Eptinezumab in people with Healthy, run by H. Lundbeck A/S at 1 site in Japan.
Trial summary
The purpose of this study is to investigate how eptinezumab enters, moves through and exits the body. Safety and tolerability will also be investigated. Read more about this study
- Who is it for?
- Ages 20 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?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteJapan
- Study dates
- 1 Apr 2020to 13 Aug 2020
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese subjects with a BMI of ≥ 18.5 and ≤ 25 kg/m2
- Other in- and exclusion criteria may apply
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Eptinezumab in Healthy Japanese Subjects
The purpose of this study is to investigate how eptinezumab enters, moves through and exits the body. Safety and tolerability will also be investigated.
Read the detailed description
The study will consist of 18 healthy Japanese subjects, divided into two single dose cohorts with 9 subjects in each cohort.
- Conditions
- Healthy
- Being tested
- Eptinezumab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EptinezumabDrug
Eptinezumab - single intravenous infusion
PlaceboDrug
Placebo - single intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 100 mg eptinezumab | Experimental | Not described Receives: Drug: Eptinezumab |
| Cohort 2 300 mg eptinezumab | Experimental | Not described Receives: Drug: Eptinezumab |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax eptinezumab
maximal observed plasma concentration
Measured: From dosing to week 12
AUC(0-t) eptinezumab
area under the plasma concentration-time curve from zero to time t
Measured: From dosing to week 12
AUC(0-inf) eptinezumab
area under the plasma concentration-time curve from zero to infinity
Measured: From dosing to week 12
Systemic Clearance of eptinezumab
Measured: From dosing to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 Apr 2020
- Primary completion13 Aug 2020
- Study completion13 Aug 2020
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
- 18 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
- NCT04336449
- Sponsor's protocol ID
- 18899A
- Status last verified
- Aug 2020
- First submitted
- 3 Apr 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. 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 Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Eptinezumab in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT04336449
- Acronym / sponsor ID
- 18899A
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 13 Aug 2020 (actual)
- Study completion
- 13 Aug 2020 (actual)
- First posted
- 7 Apr 2020 (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 how eptinezumab enters, moves through and exits the body. Safety and tolerability will also be investigated.
Detailed description
The study will consist of 18 healthy Japanese subjects, divided into two single dose cohorts with 9 subjects in each cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 100 mg eptinezumab | Experimental | Drug: Eptinezumab |
| Cohort 2 300 mg eptinezumab | Experimental | Drug: Eptinezumab |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Japanese subjects with a BMI of ≥ 18.5 and ≤ 25 kg/m2
- Other in- and exclusion criteria may apply
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| EptinezumabEptinezumab - single intravenous infusion | Drug | Cohort 1 100 mg eptinezumab, Cohort 2 300 mg eptinezumab |
| PlaceboPlacebo - single intravenous infusion | Drug | Placebo |
Primary outcome
Cmax eptinezumab
Time frame: From dosing to week 12
maximal observed plasma concentration
AUC(0-t) eptinezumab
Time frame: From dosing to week 12
area under the plasma concentration-time curve from zero to time t
AUC(0-inf) eptinezumab
Time frame: From dosing to week 12
area under the plasma concentration-time curve from zero to infinity
Systemic Clearance of eptinezumab
Time frame: From dosing to week 12
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 14 Aug 2020.
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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 Japan.
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 2 inclusion and 0 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 14 Aug 2020. 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 Japan. 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?
Cmax eptinezumab (time frame: From dosing to week 12). The study lists 4 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 14 Aug 2020.