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
Latest Information Update: 30 May 2025
At a glance
- Drugs LTG-001 (Primary)
- Indications Pain
- Focus Adverse reactions; First in man
- Sponsors Latigo Biotherapeutics
Most Recent Events
- 22 May 2025 Planned End Date changed from 28 Feb 2025 to 28 Sep 2025.
- 22 May 2025 Planned primary completion date changed from 28 Feb 2025 to 28 Jul 2025.
- 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