NCT05348993

Single or Repeat Dose of G03-52-01 in Adult Subjects

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Immunogenicity of G03-52-01 in Adult Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 622 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A Phase 2, randomized, double-blind, placebo-controlled single or repeat dose trial

Detailed description

A Phase 2, multicenter, randomized, double-blinded, placebo-controlled study to evaluate a single (100 mg) or repeat dose (50 mg and 100 mg) of G03-52-01 administered by IM injection(s) in adult subjects. Approximately 625 subjects will be enrolled in this study.

Conditions

• Healthy
• Botulinum Toxin

Interventions

Type	Name	Description
DRUG	G03-52-01	G03-52-01 administered intramuscularly
DRUG	Placebo	placebo

Timeline

• Start date: 2022-06-15
• Primary completion: 2025-02-18
• Completion: 2025-02-18
• First posted: 2022-04-27
• Last updated: 2026-02-17
• Results posted: 2026-02-17

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study