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

Clear Scientific

Status and phase: Completed; Phase 1

Conditions: Methamphetamine Intoxication; Substance Use Disorders; Methamphetamine Abuse

Treatments: Drug: Sterile Saline; Drug: CS-1103

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT06316973

U01DA053054 (U.S. NIH Grant/Contract)

CS-1103-01

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 5 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration.

Treatment:

Drug: CS-1103

Cohort 2

Experimental group

Description:

6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration.

Treatment:

Drug: CS-1103

Cohort 3

Experimental group

Description:

6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration.

Treatment:

Drug: CS-1103

Cohort 4

Experimental group

Description:

6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes. A diluted CS-1103 saline solution in an IV bag is used for drug administration.

Treatment:

Drug: CS-1103

Placebo

Placebo Comparator group

Description:

2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort.

Treatment:

Drug: Sterile Saline