CompletedPhase 1

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

United States32 participantsStarted 2024-02-07

Plain-language summary

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.

Who can participate

Age range18 Years – 55 Years

SexALL

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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.

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

What they're measuring

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

Timeframe: 3 days plus 8 days for follow-up

Number of Participants by Severity of AEs

Timeframe: 3 days plus 8 days for follow-up

Trial details

NCT IDNCT06316973

SponsorClear Scientific, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-30

Results submitted2025-09-17

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