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

NCT07110610 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2026-01-23

No results posted yet for this study

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

DRUG

LTG-321

active investigational drug

OTHER

Placebo

Placebo-to-match LTG-321

Sponsors & Collaborators

  • Latigo Biotherapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-03
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07110610 on ClinicalTrials.gov