NCT07110610

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

A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study of LTG-321 Administered Orally to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male and Female Participants 18 to 55 Years of Age

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Latigo Biotherapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	LTG-321	active investigational drug
OTHER	Placebo	Placebo-to-match LTG-321

Timeline

• Start date: 2025-09-03
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-08-07
• Last updated: 2026-01-23

Locations

1 site across 1 country: New Zealand