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

Phase 1

Completed

• Conditions: Methamphetamine Intoxication; Substance Use Disorders; Methamphetamine Abuse
• Interventions: Drug: CS-1103; Drug: Sterile Saline

• Registration Number: NCT06316973
• Lead Sponsor: Clear Scientific, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-07
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-19
• Primary Completion: 2024-05-30
• Study Completion: 2024-06-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

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

Major

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CS-1103 Single dose of CS-1103 Injection	CS-1103	CS-1103 for injection
Placebo	Sterile Saline	Sterile saline for injection

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events (AEs) assessed by vital signs	3 days plus 8 day follow-up	Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature
Number of participants with treatment-related adverse events (AEs) assessed by physical examinations	3 days plus 8 day follow-up	Physical examinations
Number of participants with treatment-related adverse events (AEs) assessed by electrocardiograms (ECGs)	3 days plus 8 day follow-up	Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted.
Number of participants with treatment-related adverse events (AEs) assessed by laboratory parameters	3 days plus 8 day follow-up	Clinical chemistry, hematology, coagulation, and urinalysis

Secondary Outcome Measures

Name	Time	Method
Time course of CS-1103 blood and urine concentrations	48 hours	Measurement of plasma and urine concentrations of CS-1103

Trial Locations

Locations (1)

Dr. Vince Clinical Research; 🇺🇸 Overland Park, Kansas, United States