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Completed

NCT Number: NCT06316973

A Clinical Study to Evaluate the Safety of CS-1103 in Healthy Participants

The purpose of this Phase 1a study is to evaluate safety, tolerability, and pharmacokinetics (PK) of single, ascending doses of CS-1103, administered by intravenous (IV) infusion in healthy participants.

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Mental Disorders Methamphetamine Abuse Methamphetamine Intoxication Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Major Inclusion Criteria:

  • Healthy male and/or female participants aged 18 to 55 years, inclusive.
  • A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 50 kg.
  • Females must be of nonchildbearing potential.

Major Exclusion Criteria:

  • Estimated glomerular filtration rate <90 mL/min/1.73 m2
  • Any clinically significant abnormalities in rhythm, conduction or morphology of the resting ECG, and any clinically important abnormalities in the 12-lead ECG
  • Current smokers, or those who have smoked or used nicotine products (including nicotine patches) within 1 month prior to dose administration.
  • History of alcohol abuse or excessive intake of alcohol

Treatment and study plan

CS-1103

Drug

CS-1103 for infusion

Sterile Saline

Drug

Sterile Saline for Injection

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (AEs)

    Time frame: 3 days plus 8 days for follow-up

    Treatment-emergent adverse events assessed through physical examinations, vital signs (blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature), electrocardiograms (digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted), and laboratory parameters (clinical chemistry, hematology, coagulation, and urinalysis).

  2. Number of Participants by Severity of AEs

    Time frame: 3 days plus 8 days for follow-up

    Severity of AEs was classified as mild, moderate, or severe (increasing severity).

    A subject experiencing multiple occurrences of an adverse event in a particular category was counted, at most, once for that category for each treatment.

Secondary outcomes

  1. Plasma Pharmacokinetic (PK) Parameter: Cmax

    Time frame: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr

    Maximum concentration, obtained directly from the observed concentration versus time data.

  2. Plasma PK Parameter: Tmax

    Time frame: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr

    Time of maximum observed blood plasma concentration (Cmax) of CS-1103

  3. Plasma PK Parameter: t1/2

    Time frame: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr

    Terminal Elimination Half-life of CS-1103

  4. Plasma PK Parameter: CL

    Time frame: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr

    Systemic Clearance of CS-1103

  5. Plasma PK Parameter: Vz

    Time frame: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr

    Volume of Distribution of CS-1103

  6. Urine PK Parameter: Fe (0-last)

    Time frame: Time intervals from 0-24 hours after IV administration of CS-1103

    Cumulative fraction of dose excreted in urine during the pooled collection intervals. Due to inherent error in measuring CS-1103 recovered in urine, the calculated recovery may exceed 100% of the dose.

Sponsors and collaborators

Lead sponsor

Clear Scientific, Inc.

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CS-1103 Following Single, Ascending Intravenous Dose Administration in Healthy Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2024
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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