HealthyPhase 1NCT03748940
Study of LY3074828 in Healthy Participants
A Phase 1 study testing LY3074828 and LY900021 in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate different concentrations and formulations of LY3074828 compared to placebo ("dummy drug"). The study will consist of 2 parts: Part A and Part B. Screening is required within 28 days prior to the start of each study part. 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?
- LY3074828 and LY900021
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Oct 2018to 18 Jun 2019
- 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
- Have venous access sufficient to allow for blood sampling and administration of investigational product
Who cannot join
- Must not have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females)
- Must not show evidence of active or latent tuberculosis (TB)
- Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 1 month of screening or intend to receive during the study
- Must not be immunocompromised
- Must not have known hypersensitivity to hyaluronidases
- Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
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- Must not have significant allergies to humanized monoclonal antibodies
- Must not have clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
- Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- Must not have had breast cancer within the past 10 years
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical Research Ltd
Leeds, West Yorkshire, LS2 9LH
About this study
Official title: A Study to Investigate the Tolerability of Subcutaneous Injections of LY3074828 Compared to Placebo
The purpose of this study is to evaluate different concentrations and formulations of LY3074828 compared to placebo ("dummy drug").
The study will consist of 2 parts: Part A and Part B. Screening is required within 28 days prior to the start of each study part. For each participant in Part A and Part B, the total duration of the clinical trial will be approximately 16 weeks, including screening.
- Conditions
- Healthy
- Being tested
- LY3074828, Placebo, LY900021
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3074828Drug
Administered SC
PlaceboDrug
Administered SC
LY900021Drug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Part A: Placebo | Placebo comparator | Placebo administered subcutaneously (SC) Receives: Drug: Placebo |
| Part A: LY3074828 | Experimental | LY3074828 administered SC Receives: Drug: LY3074828 |
| Part B: Placebo | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
| Part B: LY3074828 | Experimental | LY3074828 administered SC Receives: Drug: LY3074828 |
| Part B: LY900021 | Experimental | LY900021 (LY3074828 + LY9999QS) administered SC Receives: Drug: LY900021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Pain Score
The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain).
Measured: Within 1-minute post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start10 Oct 2018
- Primary completion18 Jun 2019
- Study completion18 Jun 2019
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
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
- NCT03748940
- Sponsor's protocol ID
- 17097
- Other IDs
- I9O-MC-AABC, 2018-000773-68, 2018
- Status last verified
- Jul 2019
- First submitted
- 28 Sep 2018
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Tolerability of Subcutaneous Injections of LY3074828 Compared to Placebo
- ClinicalTrials.gov ID
- NCT03748940
- Acronym / sponsor ID
- 17097
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 18 Jun 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 21 Nov 2018 (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 evaluate different concentrations and formulations of LY3074828 compared to placebo ("dummy drug").
The study will consist of 2 parts: Part A and Part B. Screening is required within 28 days prior to the start of each study part. For each participant in Part A and Part B, the total duration of the clinical trial will be approximately 16 weeks, including screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A: Placebo | Placebo comparator | Drug: PlaceboPlacebo administered subcutaneously (SC) |
| Part A: LY3074828 | Experimental | Drug: LY3074828LY3074828 administered SC |
| Part B: Placebo | Placebo comparator | Drug: PlaceboPlacebo administered SC |
| Part B: LY3074828 | Experimental | Drug: LY3074828LY3074828 administered SC |
| Part B: LY900021 | Experimental | Drug: LY900021LY900021 (LY3074828 + LY9999QS) administered SC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have venous access sufficient to allow for blood sampling and administration of investigational product
Key exclusion criteria (10 listed)
- Must not have an average weekly alcohol intake that exceeds 28 units per week (males) and 21 units per week (females)
- Must not show evidence of active or latent tuberculosis (TB)
- Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 1 month of screening or intend to receive during the study
- Must not be immunocompromised
- Must not have known hypersensitivity to hyaluronidases
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 |
|---|---|---|
| LY3074828Administered SC | Drug | Part A: LY3074828, Part B: LY3074828 |
| PlaceboAdministered SC | Drug | Part A: Placebo, Part B: Placebo |
| LY900021Administered SC | Drug | Part B: LY900021 |
Primary outcome
Visual Analog Scale (VAS) Pain Score
Time frame: Within 1-minute post injection
The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain).
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 19 Jul 2019.
- Individual participant dataSharing planned: No
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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
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 LY3074828 and LY900021 in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.
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 1 inclusion and 10 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 19 Jul 2019. 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 United Kingdom. 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?
Visual Analog Scale (VAS) Pain Score (time frame: Within 1-minute post injection). 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 19 Jul 2019.