HealthyPhase 1NCT02148627
Safety Study of LY3041658 in Healthy Participants
A Phase 1 study testing LY3041658 (SC) and LY3041658 (IV) in people with Healthy, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
The main purpose of this study is to evaluate the safety of LY3041658 in healthy participants, including first generation Japanese. The study will also investigate how the drug is processed and affects key immune cells. Study participation will last 4 months. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3041658 (SC) and LY3041658 (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jun 2014to 11 Feb 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All:
- Body mass index (BMI) between 18.0 to 32.0 kilogram per square meter (kg/m²).
- Absolute neutrophil count at screening should be ≥1.8 and ≤7.2 x 10^3/microliter (uL), inclusive.
- First-generation Japanese:
- Participant, biological parents, and biological grandparents must be of exclusive Japanese descent and born in Japan.
- Are 20 to 65 years of age, inclusive, at the time of initial screening.
Who cannot join
- Have received antibody-based biologic agents (marketed or investigational) within 3 months or 5 half lives (t1/2) of the drug (whichever is longer) prior to screening.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
Baltimore, Maryland, 21225
Parexel Early Phase Unit at Glendale
Glendale, California, 90216
About this study
Official title: A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3041658 in Healthy Subjects
The main purpose of this study is to evaluate the safety of LY3041658 in healthy participants, including first generation Japanese. The study will also investigate how the drug is processed and affects key immune cells. Study participation will last 4 months.
Protocol amended in January, 2016 to include first generation Japanese participants.
- Conditions
- Healthy
- Being tested
- LY3041658 (SC), LY3041658 (IV), Placebo
- Keywords
- antibody, autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3041658 (SC)Drug
Administered SC
LY3041658 (IV)Drug
Administered as slow IV infusion
PlaceboDrug
Administered as slow IV infusion
| Study group | Role | What they receive |
|---|---|---|
| LY3041658 (IV) | Experimental | Single dose of LY3041658, administered as a slow intravenous (IV) infusion in escalating dose cohorts. Receives: Drug: LY3041658 (IV) |
| LY3041658 (SC) | Experimental | Single dose of LY3041658 administered subcutaneously (SC). Receives: Drug: LY3041658 (SC) |
| Placebo | Placebo comparator | Single dose of placebo (0.9% sodium chloride injection) administered as a slow IV infusion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants with One or More Drug-Related Adverse Events
Measured: Baseline to study completion (Day 85)
Secondary outcomes (2)
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3041658
Measured: Predose through Day 85, at specified timepoints
Pharmacokinetics: Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of Last Measurable Concentration (tlast)
Measured: Predose through Day 85, at specified timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study start16 Jun 2014
- Primary completion11 Feb 2017
- Study completion11 Feb 2017
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 Eli Lilly and CompanyThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148627
- Sponsor's protocol ID
- 15164
- Other IDs
- I7P-MC-DSAA
- Status last verified
- Feb 2017
- First submitted
- 22 May 2014
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3041658 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02148627
- Acronym / sponsor ID
- 15164
- Conditions
- Healthy
- Keywords
- antibody, autoimmune
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2014 (actual)
- Primary completion
- 11 Feb 2017 (actual)
- Study completion
- 11 Feb 2017 (actual)
- First posted
- 28 May 2014 (estimated)
- 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 purpose of this study is to evaluate the safety of LY3041658 in healthy participants, including first generation Japanese. The study will also investigate how the drug is processed and affects key immune cells. Study participation will last 4 months.
Protocol amended in January, 2016 to include first generation Japanese participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY3041658 (IV) | Experimental | Drug: LY3041658 (IV)Single dose of LY3041658, administered as a slow intravenous (IV) infusion in escalating dose cohorts. |
| LY3041658 (SC) | Experimental | Drug: LY3041658 (SC)Single dose of LY3041658 administered subcutaneously (SC). |
| Placebo | Placebo comparator | Drug: PlaceboSingle dose of placebo (0.9% sodium chloride injection) administered as a slow IV infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All:
- First-generation Japanese:
Key exclusion criteria (1 listed)
- Have received antibody-based biologic agents (marketed or investigational) within 3 months or 5 half lives (t1/2) of the drug (whichever is longer) prior to screening.
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 |
|---|---|---|
| LY3041658 (SC)Administered SC | Drug | LY3041658 (SC) |
| LY3041658 (IV)Administered as slow IV infusion | Drug | LY3041658 (IV) |
| PlaceboAdministered as slow IV infusion | Drug | Placebo |
Primary outcome
The Number of Participants with One or More Drug-Related Adverse Events
Time frame: Baseline to study completion (Day 85)
2 secondary outcomes
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3041658
Time frame: Predose through Day 85, at specified timepoints
Pharmacokinetics: Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of Last Measurable Concentration (tlast)
Time frame: Predose through Day 85, at specified timepoints
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 15 Feb 2017.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
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 LY3041658 (SC) and LY3041658 (IV) in people with Healthy, run by Eli Lilly and Company 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 6 inclusion and 1 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 15 Feb 2017. 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?
The Number of Participants with One or More Drug-Related Adverse Events (time frame: Baseline to study completion (Day 85)). 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 15 Feb 2017.