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

NCT07459166 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-03-27

No results posted yet for this study

Summary

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).

Conditions

  • Fentanyl Overdose
  • Fentanyl Poisoning

Interventions

DRUG

Naloxone Hydrochloride

Naloxone for intravenous administration

DRUG

Fentanyl

Fentanyl for intravenous administration

DRUG

Sterile Saline

Sterile Saline for intravenous administration

DRUG

CS-1103

CS-1103 for intravenous administration

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Clear Scientific, Inc.

    lead INDUSTRY

Principal Investigators

  • Xinhua Li, Ph.D. · Clear Scientific, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-07-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07459166 on ClinicalTrials.gov