Clinical trial NCT01477567: A First-in-Human Study of LY3009385 in Healthy Participants
Official title: A Single Ascending Dose (SAD) Study of LY3009385 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-11-22
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to determine the safety of LY3009385 in healthy participants. The study drug is given as a single dose, by injections under the skin. Side effects will be documented. This study is approximately 28 days not including screening. Screening is required within 28 days prior to the start of the study.

Detailed description: This is a single ascending dose study that examines the safety and tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single doses of LY3009385 administered subcutaneously to healthy participants. The planned dose levels are 0.3, 1, 3, 9, 27, and 54 milligrams (mg). Within each dose level, participants are randomized to receive either LY3009385 or Placebo.

Adjustments to the dose levels were permitted after review of emerging safety, PK, and glycemic data.

The actual LY3009385 dose levels tested during this study were 0.3, 1, 3, 9, 22, and 54 mg.

Eligibility criteria: Inclusion Criteria:

* Are a healthy male or a female who cannot become pregnant
* Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m\^2) at screening
* Have blood pressure, pulse rate, as well as blood and urine laboratory test results acceptable for the study
* Have veins suitable for easy blood collection
* Are reliable and willing to be available for the whole study and be willing to follow study procedures
* Have given consent to participate in this study

Exclusion Criteria:

* Are currently participating in or were in another new drug or device or in any medical research study in the last 30 days
* Currently have or used to have allergies or other health problems or laboratory test results that in the opinion of the doctor, could make it unsafe for the participant to participate, or interfere with understanding the results of this study
* Have received live vaccine(s) within 1 month of screening, or intend to during the study
* Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing
* Have a weakened immune system
* Have previously completed or withdrawn from this study
* Have illnesses or conditions that may increase risk when taking the study medication or interfere with the interpretation of data in this study
* Have electrocardiogram (ECG) readings that are not suitable for the study
* Are using or intend to use over-the-counter medications or prescription medications within 7 and 14 days (respectively) from the start of the first study dosing until end of the study
* Have a history of drug or alcohol abuse
* Are infected with hepatitis B
* Are infected with human immunodeficiency virus (HIV)
* Have donated 450 milliliters (mL) or more of blood in the last 3 months or made any blood donation within the last month
* Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are unwilling to abstain from alcohol 24 hours before dosing until the completion of each inpatient study period
* Smoke more than 10 cigarettes per day or are unable or unwilling to refrain from smoking while at the clinic
* Are unwilling or unable to follow dietary requirements/restrictions for the study and only consume only the meals provided during inpatient stays at the clinical research unit
* Are deemed unsuitable to participate by the study doctor for any other reasons

Primary outcomes:
measure: Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs
timeFrame: Baseline through Day 28
Secondary outcomes:
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385
timeFrame: Predose through Day 28
measure: Pharmacokinetics: Maximum Concentration (Cmax)
timeFrame: Predose through Day 28
measure: Change in Level of Blood Glucose Before and After a Standard Meal
timeFrame: Baseline, Day 5, and Day 14
measure: Change in Level of C-peptide Before and After a Standard Meal
timeFrame: Baseline, Day 5, and Day 14
measure: Change in Level of Glucagon Before and After a Standard Meal
timeFrame: Baseline, Day 14
measure: Number of Participants Forming Antibody to LY3009385
timeFrame: Baseline through Day 28
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: