A Study of LY3361237 in Healthy Participants

Healthy Clinical Trial

Official title:

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3361237 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03695198
• Other study ID #: 16969
• Secondary ID: I9S-MC-BTAA
• Status: Completed
• Phase: Phase 1
• Start date: October 26, 2018
• Est. completion date: August 29, 2019

Study information

• Verified date: September 1, 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purposes of this study are to determine:

• The safety of LY3361237 and any side effects that might be associated with it.

• How much LY3361237 gets into the blood stream and how long it takes the body to remove it in healthy participants.

Participants will be admitted to the clinical research unit (CRU) for 4 overnight stays. The study will last about 12 weeks for each participant, not including screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 29, 2019
• Est. primary completion date: August 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy males or females, as determined by medical history and physical examination.

• To qualify as Japanese for this study, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.

• Between 18 (20 for Japanese participants) and 65 years of age.

• Have a body mass index of 18.0 to 32.0 kilograms per meter squared, inclusive, and a minimum body weight of 45.0 kilograms.

Exclusion Criteria:

• Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-ray and TB testing

• Are immunocompromised

• Have evidence of chronic viral infection have received live vaccine(s) (including attenuated live vaccines) within 28 days of screening or intend to receive during the study (non-live or inactivated vaccinations are allowed). Bacillus Calmette-Guérin (BCG) vaccine must not have been administered within 12 months of screening

• Have had lymphoma, leukemia, or any malignancy or pre-malignant condition 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3361237 - SC
LY3361237 administered SC
• LY3361237 - IV
LY3361237 administered IV
• Placebo - SC
Placebo administered SC
• Placebo - IV
Placebo administered IV

Locations

Country	Name	City	State
United States	California Clinical Trials Medical Group	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Week 12
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237	PK: Cmax of LY3361237	Predose through Week 12
Secondary	PK: Area Under the Plasma Concentration Time Curve (AUC) of LY3361237	PK: AUC of LY3361237	Predose through Week 12