Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY4066708 in Healthy Participants
Research type
Research Study
Full title
A Single- and Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4066708 in Healthy Participants
IRAS ID
1011341
Contact name
LaRonda Morford
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
This study is the first time LY4066708 has been given to humans. It will look at how safe the drug is and how the body handles the drug when given as a single dose in Part 1 and as multiple doses in Part 2.
The study aims to enroll up to 104 healthy volunteers. Eligibility will be assessed within 28 days prior to Day -1 (check-in). Eligible volunteers will be randomly assigned to receive either the study drug or placebo (a look-alike substance containing no drug). The volunteer and site team will not know which has been given.
In Part 1, 6 groups of 8 volunteers will receive 1 dose on Day 1, remain in resident until Day 8, and then attend further outpatient visits on 5 or 6 occasions over a further 12 weeks. 2 sub-groups will each enroll 4 volunteers of Chinese and Japanese ethnicity. Up to 64 volunteers will participate in Part 1.
In Part 2, 4 groups of 8 volunteers will receive 1 dose on 3 separate occasions on Days 1, 29, and 57 (i.e., 3 doses over 3 months), pending a review of data an optional sub-group will consist of 4 Chinese and 4 Japanese volunteers. After each dose, volunteers will remain resident for a minimum of 7 nights. Volunteers will attend for 4 visits over a period of 11 weeks. Up to 40 volunteers will participate in Part 2.
In both parts dosing will be staggered. In Part 1, 2 volunteers will be dosed first (called 'sentinels'), followed 4 days later by 3 volunteers, and then 4 days later by the last 3 volunteers. In Part 2, 2 volunteers will be dosed first, followed 4 days later by 1 volunteer, and then 4 days later by 1 volunteer and so on, such that 1 volunteer shall be dosed per week until all 8 are dosed. It is planned to gradually increase the dose of study drug for each subsequent group. Continuation of staggered dosing and dose increases will only occur if assessed as safe to do so according to a set of safety criteria.REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/007
Date of REC Opinion
22 Apr 2025
REC opinion
Further Information Favourable Opinion