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A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade

RecruitingPhase 2Ages 18 Years - 55 YearsAllClear Scientific, Inc.
NCT07459166 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 (1,000 mg), given by intravenous (IV) infusion in healthy participants in the presence of a clinically relevant dose of fentanyl (200 ฮผg, IV), with naloxone blockade (400 ฮผg, IV).

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๐Ÿ“‹ Eligibility rules (as published)
Major Inclusion Criteria: 1. Healthy participants aged 18 to 55 years, inclusive; 2. Have prior experience with opioids, such as from a dental procedure, chronic pain management, or previous inpatient surgical procedure; 3. A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 56 kg; 4. Females must not be lactating and must have a negative pregnancy test during screening and admission. Major Exclusion Criteria: 1. Estimated glomerular filtration rate \<90 mL/min/1.73 m2; 2. History of cardiovascular disease; 3. History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.
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What it tests

  • Naloxone Hydrochloride
  • Fentanyl
  • Sterile Saline
  • CS-1103
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Where

1 site
California Clinical Trials Medical Group
Glendale, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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