A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of STC-004

Phase 1

• Conditions: Acute, post-operative pain; Chronic, peripheral neuropathic pain; Anaesthesiology - Pain management

• Registration Number: ACTRN12624000642583
• Lead Sponsor: SiteOne Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-20
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Healthy male and/or female, 18 to 55 years of age, inclusive with BMI between 18.0 to 32.0 kg/m2, inclusive
- Medically healthy without clinically significant abnormalities based on physical examination, vital signs, ECG, and clinical laboratory tests

Exclusion Criteria

- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or surgery within the past 3 months determined by an Investigator to be clinically relevant.
- History of drug or alcohol abuse
- Use of an prescription medications or over-the-counter medications (excluding contraceptives), including herbal products and vitamins within 14 days or 5 half-lives (whichever is longer)
- Blood donation of approximately 500 mL within 56 prior to Screening
- Any condition or prior therapy, eg. seizures or head trauma, that may lead to CNS effects during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified