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A Phase 1 Single and Multiple Ascending Dose Study of LTG-305 Administered Orally in Healthy Participants

NCT06554574 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-07-04

No results posted yet for this study

Summary

This is a sequential, randomized, double-blind, placebo-controlled Phase 1 single (SAD) and multiple (MAD) ascending dose study to evaluate the safety, tolerability, and pharmacokinetics (PK) and Pharmacodynamics of orally administered LTG-305 in healthy male and female participants. The study will also include a randomized, double-blind, placebo-controlled within-participant crossover evaluation of pain tolerance during a cold pressor test in healthy male participants 18-55 years of age.

Conditions

  • Healthy

Interventions

DRUG

LTG-305

Part A: Single-Ascending dose cohorts; Part B: Multiple-ascending dose cohorts

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
2024-09-03
Primary Completion
2025-06-16
Completion
2025-06-16

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 NCT06554574 on ClinicalTrials.gov