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

Clear Scientific, Inc.32 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Substance Use Disorders Methamphetamine Abuse Methamphetamine Intoxication

Interventions

CS-1103DRUG

CS-1103 for infusion

Sterile SalineDRUG

Sterile Saline for Injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dr. Vince Clinical Research

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: 3 days plus 8 days for follow-up

Secondary Outcomes

Plasma Pharmacokinetic (PK) Parameter: Cmax

Maximum concentration, obtained directly from the observed concentration versus time data.

Time frame: 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

Time of maximum observed blood plasma concentration (Cmax) of CS-1103

Time frame: 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

Terminal Elimination Half-life of CS-1103

Time frame: 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

Systemic Clearance of CS-1103

Data from ClinicalTrials.gov

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