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

NCT ID: NCT06316973

Last Updated: 2025-11-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-07

Study Completion Date

2024-06-06

Brief Summary

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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

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Conditions

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Substance Use Disorders Methamphetamine Abuse Methamphetamine Intoxication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1

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.

Group Type EXPERIMENTAL

CS-1103

Intervention Type DRUG

CS-1103 for infusion

Cohort 2

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.

Group Type EXPERIMENTAL

CS-1103

Intervention Type DRUG

CS-1103 for infusion

Cohort 3

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.

Group Type EXPERIMENTAL

CS-1103

Intervention Type DRUG

CS-1103 for infusion

Cohort 4

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.

Group Type EXPERIMENTAL

CS-1103

Intervention Type DRUG

CS-1103 for infusion

Placebo

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.

Group Type PLACEBO_COMPARATOR

Sterile Saline

Intervention Type DRUG

Sterile Saline for Injection

Interventions

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CS-1103

CS-1103 for infusion

Intervention Type DRUG

Sterile Saline

Sterile Saline for Injection

Intervention Type DRUG

Eligibility Criteria

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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.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Clear Scientific, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dr. Vince Clinical Research

Overland Park, Kansas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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U01DA053054

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CS-1103-01

Identifier Type: -

Identifier Source: org_study_id