Phase 1 Single and Multiple Ascending Dose of LTG-321 in Healthy Participants

This is a first-in-human, randomized, double-blind, placebo-controlled Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of orally administered LTG-321 in healthy male and female participants 18 to 55 years of age. The study will be conducted in New Zealand. The study also includes a randomized, double-blind, placebo-controlled, within-participant crossover evaluation of pain tolerance using a cold pressor test in healthy male participants 18 to 55 years of age. In addition, a randomized, open-label, crossover Food Effect cohort will evaluate the impact of a high-fat meal on the pharmacokinetics of LTG-321 following single oral doses in the fed and fasted state.

NCT Number	NCT07110610
Lead Sponsor	Latigo Biotherapeutics
Conditions	Healthy Participants
Enrollment	112 participants
Start Date	2025-09-03
Primary Completion	2026-03-08 (estimated)
Study Completion	2026-03-08 (estimated)
Updated on ClinicalTrials.gov	2026-06-29