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A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Male and Female Participants 18 to 55 Years of Age

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A Sequential, Randomized, Double-Blind, Placebo-Controlled, Phase 1 Single and Multiple Ascending Dose Study of LTG-001 Administered Orally to Evaluate the Safety, Tolerability, and Pharmacokinetics in Healthy Male and Female Participants 18 to 55 Years of Age

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 05 Mar 2025

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At a glance

  • Drugs LTG-001 (Primary)
  • Indications Pain
  • Focus Adverse reactions; First in man
  • Sponsors Latigo Biotherapeutics

    • Most Recent Events

    • 03 Mar 2025 According to Latigo Biotherapeutics media release, company announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to LTG-001 following positive Phase 1 results which demonstrated a favorable safety, tolerability, and pharmacokinetic profile for LTG-001
    • 19 Aug 2024 Results (n=72) presented in a Latigo Biotherapeutics media release.
    • 13 Aug 2024 Planned End Date changed from 31 May 2024 to 28 Feb 2025.

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