CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 622 enrolled
Drug / intervention
G03-52-01 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Healthy male or healthy, non-pregnant, non-lactating female between 18 and 65 years old
  • ✓BMI 18.5-35 kg/m²
  • ✓Screening clinical laboratory results within normal ranges or Grade 1 and not clinically significant
  • ✓Negative serology for HIV, hepatitis B surface antigen, and hepatitis C virus antibodies
Key exclusion· 10
  • ✕History of chronic medical conditions including diabetes, asthma requiring medication, autoimmune disorders, coronary artery disease, malignancy (except low-grade skin cancer), or chronic renal, hepatic, pulmonary, or endocrine disease
  • ✕Known severe allergic reactions to medications, bee stings, food, environmental factors, or immunoglobulins (anaphylaxis, urticaria, angioedema)
  • ✕Known allergic reactions to study product components
  • ✕QTc interval >450 milliseconds or clinically significant ECG abnormalities

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05348993
NCT05348993Phase 2Completed
CompareCT.gov

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

U.S. Army Medical Research and Development Command·interventional·Posted Apr 27, 2022·Updated Feb 17, 2026

In Brief

A Phase 2 clinical trial evaluating G03-52-01 and Placebo for Healthy and Botulinum Toxin. Completed, enrolled 622 participants across 15 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy, Botulinum Toxin
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedApr 27, 2022
Enrollment StartJun 15, 2022
Primary CompletionFeb 18, 2025
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 4.2 years ago

Interventions

G03-52-01drug

G03-52-01 administered intramuscularly

Placebodrug

placebo