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Clinical trial

A Safety, Tolerability, and Pharmacokinetic Study of Injections of LY3074828 Solution Using Investigational 1-mL Pre-filled Syringes and Investigational 1-mL Autoinjector in Healthy Subjects

ID
Name
16780
Description
The purpose of this study is to learn about the effects of LY3074828 when given as an injection just under the skin by two different devices. The study will last about 12 weeks for each participant.
Trial arms
Trial start
2019-03-27
Estimated PCD
2019-10-04
Trial end
2019-10-04
Status
Completed
Phase
Early phase I
Treatment
LY3074828
Administered subcutaneously (SC)
Arms:
125 mg LY3074828 Autoinjector (AI), 125 mg LY3074828 Prefilled Syringe (PFS)
Pre-filled syringe (PFS)
PFS used to administer LY3074828
Arms:
125 mg LY3074828 Prefilled Syringe (PFS)
Autoinjector (AI)
AI used to administer LY3074828
Arms:
125 mg LY3074828 Autoinjector (AI)
Size
66
Primary endpoint
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828
Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85
PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t (AUC(0-tlast) of LY3074828, Where t is the Last Sample With a Measurable Concentration
Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3074828
Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85
Visual Analog Scale (VAS) Pain Score by Device
Day 1: 1, 5 (±1.5) and 15 (±2) minutes
Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location
Day 1: 1, 5 (±1.5) and 15 (±2) minutes
Eligibility criteria
Inclusion Criteria: - Must be healthy males or females Exclusion Criteria: * Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/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 8 weeks of screening, or intend to during the study * Must not have been treated with steroids within 1 month of screening, or intend to during the study * Must not be immunocompromised * 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 Day 1 * Must not have significant allergies to humanised monoclonal antibodies * Must not have clinically significant multiple or severe drug allergies, or 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}
Updated at
2024-02-20

1 organization

1 product

1 indication

Organization
Eli Lilly and Company
Product
LY3074828
Indication
Healthy