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RecruitingAccepts healthy volunteersPhase 2

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

Clear Scientific, Inc. · with National Institute on Drug Abuse (NIDA) · NCT07459166

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–55 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
16
US sites recruiting
1
Study start
May 28, 2026
Record last updated
August 24, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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 μg, IV), with naloxone blockade (400 μg, IV).

Being studied: Naloxone Hydrochloride; Fentanyl; Sterile Saline; CS-1103

Conditions: Fentanyl Overdose; Fentanyl Poisoning

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Major Inclusion Criteria

  • Healthy participants aged 18 to 55 years, inclusive;
  • Have prior experience with opioids, such as from a dental procedure, chronic pain management, or previous inpatient surgical procedure;
  • A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 56 kg;
  • Females must not be lactating and must have a negative pregnancy test during screening and admission.

Major Exclusion Criteria

  • Estimated glomerular filtration rate \<90 mL/min/1.73 m2;
  • History of cardiovascular disease;
  • History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.

Recruiting US locations

  • California Clinical Trials Medical Group

    Glendale, CA 91206

    Site contact: Lev Gertsik, M.D. · 888-228-7425 · study.losangeles@parexel.com

Study contacts (from the official record)

  • Anna Del Rosario, B.S. · 617-621-8500 · adelrosario@clearsci.com
  • Piercen Oliver, Ph.D. · 617-621-8500 · poliver@clearsci.com
All healthy volunteers studies in California →
A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103… (NCT07459166) | Bored Studies