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

March 12, 2024 updated by: Clear Scientific, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Recruiting
        • Dr. Vince Clinical Research
        • Contact:
          • Lori Adriano
          • Phone Number: 913-333-3000
        • Principal Investigator:
          • Steven Hull, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Sterile saline for injection
Drug: Sterile Saline
Sterile Saline for Injection
Experimental: CS-1103 Single dose of CS-1103 Injection
CS-1103 for injection
Drug: CS-1103
CS-1103 for infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events (AEs) assessed by physical examinations
Time Frame: 3 days plus 8 day follow-up
Physical examinations
3 days plus 8 day follow-up
Number of participants with treatment-related adverse events (AEs) assessed by vital signs
Time Frame: 3 days plus 8 day follow-up
Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature
3 days plus 8 day follow-up
Number of participants with treatment-related adverse events (AEs) assessed by electrocardiograms (ECGs)
Time Frame: 3 days plus 8 day follow-up
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
Number of participants with treatment-related adverse events (AEs) assessed by laboratory parameters
Time Frame: 3 days plus 8 day follow-up
Clinical chemistry, hematology, coagulation, and urinalysis
3 days plus 8 day follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time course of CS-1103 blood and urine concentrations
Time Frame: 48 hours
Measurement of plasma and urine concentrations of CS-1103
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clear Scientific, Inc.

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-1103-01
  • U01DA053054 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Substance Use Disorders

Clinical Trials on CS-1103

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe