HealthyPhase 1NCT02595736
A Study of LY3200327 in Healthy Participants
A Phase 1 study testing LY3200327 (SC) and LY3200327 (IV) in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to look at the safety and tolerability of single doses of LY3200327 when given to healthy male and female participants either by injection under the skin or by drip into a vein. 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?
- LY3200327 (SC) and LY3200327 (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Aug 2016
- 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
- At the time of initial screening, in general good health
- First-generation healthy Japanese (age 20 to 65 years) will be included
Who cannot join
- Pregnancy or breastfeeding during the study
- Chronic infection
- Treatment with prohibited medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Parexel International/ California Clinical Trials
Glendale, California, 91206
About this study
Official title: A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3200327 in Healthy Subjects
The purpose of this study is to look at the safety and tolerability of single doses of LY3200327 when given to healthy male and female participants either by injection under the skin or by drip into a vein. The study will help determine how the drug behaves inside the body and how long it takes to disappear from the body. The study will also look for anti-drug antibodies and how these may affect how LY3200327 acts in your body.
The study is expected to last approximately 12 weeks (with screening evaluations up to 4 weeks prior).
- Conditions
- Healthy
- Being tested
- Placebo (SC), LY3200327 (SC), LY3200327 (IV), Placebo (IV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (SC)Drug
Administered SC
LY3200327 (SC)Drug
Administered SC
LY3200327 (IV)Drug
Administered IV
Placebo (IV)Drug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Placebo (SC) | Placebo comparator | Single subcutaneous (SC) dose of placebo Receives: Drug: Placebo (SC) |
| LY3200327 (SC) | Experimental | Single escalating subcutaneous (SC) dose of LY3200327 Receives: Drug: LY3200327 (SC) |
| LY3200327 (IV) | Experimental | Single intravenous (IV) dose of LY3200327 Receives: Drug: LY3200327 (IV) |
| Placebo (IV) | Placebo comparator | Single intravenous (IV) dose of placebo Receives: Drug: Placebo (IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Measured: Baseline to study completion (approximately 12 weeks)
Secondary outcomes (2)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3200327
Measured: Pre-dose up to 84 days post dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3200327
Measured: Pre-dose up to 84 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2016
- Study completionAug 2016
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
- 52 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
- NCT02595736
- Sponsor's protocol ID
- 15577
- Other IDs
- I8C-MC-GSFA
- Status last verified
- Sep 2016
- First submitted
- 2 Nov 2015
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. 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 LY3200327 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02595736
- Acronym / sponsor ID
- 15577
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 3 Nov 2015 (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 purpose of this study is to look at the safety and tolerability of single doses of LY3200327 when given to healthy male and female participants either by injection under the skin or by drip into a vein. The study will help determine how the drug behaves inside the body and how long it takes to disappear from the body. The study will also look for anti-drug antibodies and how these may affect how LY3200327 acts in your body.
The study is expected to last approximately 12 weeks (with screening evaluations up to 4 weeks prior).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo (SC) | Placebo comparator | Drug: Placebo (SC)Single subcutaneous (SC) dose of placebo |
| LY3200327 (SC) | Experimental | Drug: LY3200327 (SC)Single escalating subcutaneous (SC) dose of LY3200327 |
| LY3200327 (IV) | Experimental | Drug: LY3200327 (IV)Single intravenous (IV) dose of LY3200327 |
| Placebo (IV) | Placebo comparator | Drug: Placebo (IV)Single intravenous (IV) dose of placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At the time of initial screening, in general good health
- First-generation healthy Japanese (age 20 to 65 years) will be included
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding during the study
- Chronic infection
- Treatment with prohibited medications
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 |
|---|---|---|
| Placebo (SC)Administered SC | Drug | Placebo (SC) |
| LY3200327 (SC)Administered SC | Drug | LY3200327 (SC) |
| LY3200327 (IV)Administered IV | Drug | LY3200327 (IV) |
| Placebo (IV)Administered IV | Drug | Placebo (IV) |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline to study completion (approximately 12 weeks)
2 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3200327
Time frame: Pre-dose up to 84 days post dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3200327
Time frame: Pre-dose up to 84 days post dose
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 Sep 2016.
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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 LY3200327 (SC) and LY3200327 (IV) in people with Healthy, run by Eli Lilly and Company at 1 site 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 2 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 12 Sep 2016. 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 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?
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline to study completion (approximately 12 weeks)). 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 Sep 2016.