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

Substance Use Disorders Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06316973
• Other study ID #: CS-1103-01
• Secondary ID: U01DA053054
• Status: Recruiting
• Phase: Phase 1
• Start date: February 7, 2024
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: Clear Scientific, Inc.
• Contact: Piercen Oliver, Ph.D.
• Phone: 617-621-8500
• Email: poliver[@]clearsci.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Major 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

Related Conditions & MeSH terms

• Methamphetamine Abuse
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Drug:
• CS-1103
CS-1103 for infusion
• Sterile Saline
Sterile Saline for Injection

Locations

Country	Name	City	State
United States	Dr. Vince Clinical Research	Overland Park	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Clear Scientific, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events (AEs) assessed by physical examinations	Physical examinations	3 days plus 8 day follow-up
Primary	Number of participants with treatment-related adverse events (AEs) assessed by vital signs	Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature	3 days plus 8 day follow-up
Primary	Number of participants with treatment-related adverse events (AEs) assessed by electrocardiograms (ECGs)	Digital 12-lead electrocardiograms (ECGs). Any relationship between CS-1103 plasma concentrations and changes in QT intervals will be noted.	3 days plus 8 day follow-up
Primary	Number of participants with treatment-related adverse events (AEs) assessed by laboratory parameters	Clinical chemistry, hematology, coagulation, and urinalysis	3 days plus 8 day follow-up
Secondary	Time course of CS-1103 blood and urine concentrations	Measurement of plasma and urine concentrations of CS-1103	48 hours