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

NCT06316973 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: CS-1103-01U01DA053054
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders; Methamphetamine Abuse; Methamphetamine Intoxication

Outcome Measures

Primary Outcomes (2)

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

  Treatment-emergent adverse events assessed through physical examinations, vital signs (blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature), electrocardiograms (digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted), and laboratory parameters (clinical chemistry, hematology, coagulation, and urinalysis).

  3 days plus 8 days for follow-up

• Number of Participants by Severity of AEs

  Severity of AEs was classified as mild, moderate, or severe (increasing severity). A subject experiencing multiple occurrences of an adverse event in a particular category was counted, at most, once for that category for each treatment.

  3 days plus 8 days for follow-up

Secondary Outcomes (6)

• Plasma Pharmacokinetic (PK) Parameter: Cmax

  End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr

• Plasma PK Parameter: Tmax

  End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr

• Plasma PK Parameter: t1/2

  End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr

• Plasma PK Parameter: CL

  End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr

• Plasma PK Parameter: Vz

  End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hr

Study Arms (5)

Cohort 1

EXPERIMENTAL

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.

Drug: CS-1103

Cohort 2

EXPERIMENTAL

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.

Drug: CS-1103

Cohort 3

EXPERIMENTAL

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.

Drug: CS-1103

Cohort 4

EXPERIMENTAL

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.

Drug: CS-1103

Placebo

PLACEBO COMPARATOR

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.

Drug: Sterile Saline

Interventions

CS-1103 DRUG

CS-1103 for infusion

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Sterile Saline DRUG

Sterile Saline for Injection

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clear Scientific, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Piercen Oliver
• Organization: Clear Scientific

poliver@clearsci.com

617-621-8500

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 19, 2024
• Study Start: February 7, 2024
• Primary Completion: May 30, 2024
• Study Completion: June 6, 2024
• Last Updated: November 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)