Comparing Efficacy & Safety Of TNX-1300 To Placebo With UC For Treatment Of Acute Cocaine Intoxication In ED Subjects (CATALYST)

NCT06045793 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: TNX-CE-CI2025U01DA056245
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 6

Brief Summary

This is a Phase 2 single-blind, randomized, multicenter study to compare the efficacy and safety of a single dose of TNX-1300 to placebo with usual care in patients with acute cocaine intoxication within the emergency department setting.

Conditions

Cocaine Use; Cocaine Intoxication; Cocaine Toxicity; Cocaine Abuse; Cocaine Adverse Reaction

Keywords

Emergency Department; Cocaine; Cocaine Intoxication; Cocaine Esterase

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Systolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC

  Patients will undergo a Systolic BP assessment at Baseline and at 60 minutes after dosing.

  60 minutes after IV administration

Secondary Outcomes (3)

• Change from Baseline in QT interval corrected for heart rate (QTc) at 15 minutes after dosing, comparing TNX-1300 to placebo with UC

  15 minutes after IV administration

• Change from Baseline in diastolic BP at 60 minutes after dosing, comparing TNX-1300 to placebo with UC

  60 minutes after IV administration

• Change from Baseline in Stimulant Intoxication Scale (SIS) total score at 60 minutes after dosing, comparing TNX-1300 to placebo with UC

  60 minutes after IV administration

Study Arms (2)

TNX-1300

EXPERIMENTAL

A single IV 200 mg injection of TNX-1300

Drug: TNX-1300 (Injection)

Placebo

PLACEBO COMPARATOR

A single IV injection of placebo with UC

Drug: Placebo (Injection)

Interventions

TNX-1300 (Injection) DRUG

Patients will receive a single IV injection of TNX-1300.

Also known as: Cocaine esterase

TNX-1300

Placebo (Injection) DRUG

Patients will receive a single IV injection of placebo with usual care (UC).

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is male or female and is 18-64 years of age.
• Subject has the capacity to provide voluntary written informed consent. In cases in which the investigator is unclear if the subject has the capacity to consent, a determination regarding capacity must be made by a psychiatrist trained in assessment of capacity to consent to research in order for the subject to be eligible.
• At Screening, subject presents with cardiac symptoms while intoxicated with cocaine, inclusive of elevated systolic or diastolic BP, as defined below, with or without behavioral symptoms:
• Systolic BP \>140 mmHg, or
• Diastolic BP \>90 mmHg Note: subjects with a QT interval corrected for heart rate (QTc) \>500 msec may be eligible for study participation, based on investigator judgment.
• At Screening and Baseline assessments, subject must have a SIS total score of ≥4
• At Baseline, subject has a CGI-S score ≥3.
• Subject has a positive urine drug screen test at Pre-screening to confirm cocaine use and detect polysubstance abuse (subject may test positive for cannabinoids and/or opioids and remain eligible; subject may test positive for alcohol by breathalyzer and remain eligible).
• Subject must be willing to practice the following:
• If female, practice one of the following methods of birth control throughout the study and for 28 days after study drug administration:
• Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of one full cycle (based on the patient's usual menstrual cycle period) before study drug administration;
• Intrauterine device;
• Bilateral tubal ligation
• Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jelly or cream);
• If male, practice double-barrier method throughout the study and for 28 days after study drug administration, if female partner is not following birth control methods a-c mentioned above

You may not qualify if:

• Subject who has been admitted to the ED involuntarily.
• Subject who participated in this clinical study previously.
• Subject has a score of 3 on the systolic and/or diastolic BP SIS components, a "mental state" or "orientation" SIS component score of ≥2, or an "orientation" SIS component score of ≥1 and the subject is not oriented to either person or place (i.e., only disorientation to time is allowed).
• Subject who, at Screening, expresses C-SSRS suicidal ideation of Type 4 or 5 in the prior week or any C-SSRS suicidal behavior in the prior week.
• Subject tests positive for stimulant drugs of abuse other than cocaine, including methylphenidate, 3,4-methylenedioxymethamphetamine, methamphetamine, or other amphetamines at Screening.
• Subject has a clinically significant untreated cardiac condition, such as prior myocardial infarction, current ischemia assessed by ECG-based criteria, aortic dissection, ventricular fibrillation, Torsade de pointes, ventricular tachycardia, cardiomyopathy, pulmonary edema, cardiac arrest, significant conduction disturbance (e.g., greater than first degree heart block), QRS interval \>120 msec, or severe or life-threatening hypertension. Untreated hypertension may be allowed if not considered severe or life-threatening. Note: hypertension will be considered severe or life-threatening if systolic BP is \>200 mmHg and/or diastolic BP is \>130 mmHg.
• Subject incurred or is likely to incur a myocardial infarction or other life-threatening severe event or has acute ECG changes indicative of acute coronary syndrome according to investigator judgment. Such changes may include new, transient, or dynamic ST-segment elevation, ST-depression, or significant Q waves. Based on investigator judgement, T-wave inversion and T-wave flattening may also be considered in the risk assessment for acute coronary syndrome.
• Subject has a heart rate ≥180 bpm, atrial fibrillation, greater than first degree heart block, or chest pain with ECG-based evidence of ischemia.
• Subject has a clinically significant or unstable medical illness, condition, or disorder that can compromise subject safety or adversely affect the evaluation of clinical outcome parameters.
• Subject has a clinical history of anaphylaxis, severe asthma, hypersensitivity, or angioedema.
• Subject requires physical restraints due to physiological and/or behavioral symptoms.
• Subject receives anti-hypertensive medication(s) in the ED prior to study enrollment.
• Subject is pregnant or breastfeeding.
• Participation in another investigational drug study (current or within 30 days of Screening) or previous participation in a study of TNX-1300.

Sponsors & Collaborators

• Tonix Pharmaceuticals, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Premier: collaborator

Study Sites (6)

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

Location

University Of Maryland Medical Center

Baltimore, Maryland, 37601, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Wayne State University

Detroit, Michigan, 48235, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Baylor College of Medicine, Ben Taub Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders; Emergencies

Interventions

Injections; cocaine esterase

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Gregory Sullivan, MD

  Tonix Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded to which treatment arm they are assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: August 16, 2024
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)