HealthyPhase 1NCT05959109
A Relative Bioavailability Study of Peresolimab (LY3462817) Formulations in Healthy Participants
A Phase 1 study testing Peresolimab in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The main purpose of this study is to look at the amount of the study drug, peresolimab, that gets into the blood stream and how long it takes the body to get rid of it when given under the skin using test formulations versus reference formulation in healthy participants. 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?
- Peresolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2023to 11 Jan 2024
- 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
- Male and female participants who are overtly healthy as determined by medical history, physical examination, and other screening procedures
- A minimum body weight of 45 kilograms and body mass index (BMI) between 18.0 and 32.0 kilograms per meter squared (kg/m²), inclusive, at screening
- Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
- Males who agree to use highly effective/effective methods of contraception and women not of childbearing potential
Who cannot join
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study intervention, or of interfering with the interpretation of data
- Have a history of allergy to monoclonal antibody therapy or to the excipients in the drug formulation, or have clinically significant intolerance to topical corticosteroids, or a history of severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis).
- Have a diagnosis or history of malignant disease within 5 years prior to screening, with the following exceptions:
- basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to screening.
- Are immunocompromised.
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- Have known hypogammaglobulinemia
- Have a current or recent acute, active infection. For at least 30 days before screening and up to the baseline visit, participants must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment.
- Have had any of the following types of infection within 3 months prior to the screening visit or develops any of these infections before the baseline visit:
- serious (requiring hospitalization, or IV or equivalent oral antibiotic treatment, or both)
- opportunistic (as defined in Winthrop et al. 2015)
- chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer)
- recurring (including, but not limited to, herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis).
- Have active TB.
- Have or have had latent tuberculosis infection that has not been treated with a complete course of appropriate therapy as defined by the World Health Organization and the United States Centers for Disease Control and Prevention, unless such treatment is underway.
- Have a current infection with HBV (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA).
- Have a current infection with HCV (that is, positive for HCV RNA).
- Have HIV infection.
- Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- Have received any live vaccine (that is, live attenuated) within less than 4 weeks before screening or intend to receive a live vaccine during the study, or within 5 half-lives (8 weeks) after receiving the last dose of study intervention, whichever is longer. Note: The following are not considered live vaccines: RNA vaccines, vaccines with inactive viral elements, and/or nonreplicating viral vector vaccines.
- Have received a bacille Calmette-Guerin vaccination or treatment within less than 4 weeks before screening or intend to receive bacille Calmette-Guerin vaccination or treatment during the study, or within 5 half-lives (8 weeks) after receiving the last dose of study intervention, whichever is longer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Dose Study to Assess the Relative Bioavailability and Tolerability of Subcutaneous Peresolimab Test Formulations in Healthy Participants
The main purpose of this study is to look at the amount of the study drug, peresolimab, that gets into the blood stream and how long it takes the body to get rid of it when given under the skin using test formulations versus reference formulation in healthy participants. The study will also evaluate the safety and tolerability of peresolimab and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 17 weeks, including screening.
- Conditions
- Healthy
- Being tested
- Peresolimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeresolimabDrug
Also called LY3462817
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Peresolimab (Test 1) | Experimental | Peresolimab administered subcutaneously (SC). Receives: Drug: Peresolimab |
| Peresolimab (Test 2) | Experimental | Peresolimab administered SC. Receives: Drug: Peresolimab |
| Peresolimab (Test 3) | Experimental | Peresolimab administered SC. Receives: Drug: Peresolimab |
| Peresolimab (Reference) | Experimental | Peresolimab administered SC. Receives: Drug: Peresolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Peresolimab
PK: Cmax of Peresolimab
Measured: Predose up to 85 days postdose
PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of Peresolimab
PK: AUC[0-tlast] of Peresolimab
Measured: Predose up to 85 days postdose
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Peresolimab
PK: AUC(0-∞) of Peresolimab
Measured: Predose up to 85 days postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start21 Jul 2023
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 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
- NCT05959109
- Sponsor's protocol ID
- 18608
- Other IDs
- J1A-MC-KDAI
- Status last verified
- Jan 2024
- First submitted
- 17 Jul 2023
- Last updated
- 29 Jan 2024
- 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 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose Study to Assess the Relative Bioavailability and Tolerability of Subcutaneous Peresolimab Test Formulations in Healthy Participants
- ClinicalTrials.gov ID
- NCT05959109
- Acronym / sponsor ID
- 18608
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 25 Jul 2023 (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 main purpose of this study is to look at the amount of the study drug, peresolimab, that gets into the blood stream and how long it takes the body to get rid of it when given under the skin using test formulations versus reference formulation in healthy participants. The study will also evaluate the safety and tolerability of peresolimab and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 17 weeks, including screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Peresolimab (Test 1) | Experimental | Drug: PeresolimabPeresolimab administered subcutaneously (SC). |
| Peresolimab (Test 2) | Experimental | Drug: PeresolimabPeresolimab administered SC. |
| Peresolimab (Test 3) | Experimental | Drug: PeresolimabPeresolimab administered SC. |
| Peresolimab (Reference) | Experimental | Drug: PeresolimabPeresolimab administered SC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female participants who are overtly healthy as determined by medical history, physical examination, and other screening procedures
- A minimum body weight of 45 kilograms and body mass index (BMI) between 18.0 and 32.0 kilograms per meter squared (kg/m²), inclusive, at screening
- Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
- Males who agree to use highly effective/effective methods of contraception and women not of childbearing potential
Key exclusion criteria (21 listed)
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study intervention, or of interfering with the interpretation of data
- Have a history of allergy to monoclonal antibody therapy or to the excipients in the drug formulation, or have clinically significant intolerance to topical corticosteroids, or a history of severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis).
- Have a diagnosis or history of malignant disease within 5 years prior to screening, with the following exceptions:
- Are immunocompromised.
- Have known hypogammaglobulinemia
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 |
|---|---|---|
| PeresolimabAlso: LY3462817Administered SC | Drug | Peresolimab (Reference), Peresolimab (Test 1), Peresolimab (Test 2), Peresolimab (Test 3) |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Peresolimab
Time frame: Predose up to 85 days postdose
PK: Cmax of Peresolimab
PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of Peresolimab
Time frame: Predose up to 85 days postdose
PK: AUC[0-tlast] of Peresolimab
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Peresolimab
Time frame: Predose up to 85 days postdose
PK: AUC(0-∞) of Peresolimab
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 29 Jan 2024.
- 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 Peresolimab 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 4 inclusion and 21 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 29 Jan 2024. 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. 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?
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Peresolimab (time frame: Predose up to 85 days postdose). The study lists 3 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 29 Jan 2024.