A Phase 1 Randomized, Placebo-Controlled Study of LY3316531 in Healthy Subjects and an Open-Label, Single-Dose Study in Patients With Psoriasis
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 63
- Locations
- 2
- Primary Endpoint
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Study Overview
Brief Summary
The purpose of this study is to evaluate how well LY3316531 is tolerated and what side effects may occur in healthy participants and participants with psoriasis. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm).
This is a three-part study. Participants will enroll in only one part. Parts A and B are for healthy participants and Part C is for participants with psoriasis. Participation could last between 16 and 57 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy Participants
- •Are overtly healthy males or females, as determined by medical history and physical examination
- •Females must be of non-childbearing potential
- •Are between 18 and 64 years of age, inclusive, at screening
- •Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
- •Psoriasis Participants:
- •Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline
- •Meet psoriasis disease activity criteria
- •Are at least 18 years of age
- •Have a minimum body weight of 50 kilograms (kg)
Exclusion Criteria
- •Healthy and Psoriasis Participants
- •Have known or ongoing neuropsychiatric disorders
- •Have received live vaccine(s) (included attenuated live vaccines) within 28 days of screening or intend to during the study
- •Have had any malignancy within the past 5 years except for basal cell or squamous cell epithelial carcinomas of the skin that have been resected with no subsequent evidence of recurrence for at least 3 years prior to screening and cervical carcinoma in situ with no evidence of recurrence within 5 years prior to baseline
- •Show evidence of active or latent tuberculosis (TB)
- •Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data
- •Psoriasis Participants Only:
- •Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy)
- •Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval
- •Have received systemic nonbiologic psoriasis therapy within 28 days of baseline
- •Have received topical psoriasis treatment within 14 days of baseline
Arms & Interventions
LY3316531 (Part A)
Participants received single doses of 3 milligrams (mg), 15 mg, 75 mg, 300 mg, 900 mg, or 2000 mg LY3316531 administered Intravenously (IV), or 300 mg LY3316531 administered Subcutaneously (SC).
Intervention: LY3316531 - IV (Drug)
LY3316531 (Part A)
Participants received single doses of 3 milligrams (mg), 15 mg, 75 mg, 300 mg, 900 mg, or 2000 mg LY3316531 administered Intravenously (IV), or 300 mg LY3316531 administered Subcutaneously (SC).
Intervention: LY3316531 - SC (Drug)
Placebo (Part A)
Placebo matching LY3316531 administered IV.
Intervention: Placebo - IV (Drug)
LY3316531 (Part B)
Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
Intervention: LY3316531 - IV (Drug)
Placebo (Part B)
Placebo matching LY3316531 administered IV.
Intervention: Placebo - IV (Drug)
LY3316531 (Part C)
Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.
Intervention: LY3316531 - IV (Drug)
Outcomes
Primary Outcomes
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: Pre-dose up to 1 year after administration of study drug
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is reported in the Reported Adverse Events module. An SAE is any adverse event from this study that results in 1 of the following: 1. Death 2. Initial or prolonged inpatient hospitalization 3. A life-threatening experience (that is, immediate risk of dying) 4. Persistent or significant disability/incapacity 5. Congenital anomaly/birth defect 6. Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above.
Secondary Outcomes
- Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531(Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose)
- Part B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531(Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85)
- Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531(Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose)
- Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)(Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose)
- Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 Over the Dosing Interval (Tau) - AUCtau(Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85)
- Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)(Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose)