Safety and Efficacy of Trans Sodium Crocetinate (TSC) in Enhancing Tissue Oxygen Levels in Healthy Volunteers

NCT04808622 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 200-301
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, double-blind, placebo-controlled, pharmacokinetic, pharmacodynamic study. Subjects will be randomized to TSC or placebo to determine the effect of Trans Sodium Crocetinate (TSC) on Transcutaneous Oximetry Measurements (tcpO2) following a single administration of TSC in subjects breathing oxygen (O2).

Conditions

Healthy Subjects

Keywords

Transcutaneous oximetry

Outcome Measures

Primary Outcomes (1)

• Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.

  Summary Statistics of tcpO2 Levels (mmHg) Overall Measurements (Median of 4 Sensors) in Healthy Subjects

  0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes post-dose

Other Outcomes (1)

• Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo.

  0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes post-dose

Study Arms (6)

TSC 0.5 mg/kg

EXPERIMENTAL

TSC 0.5 mg/kg given as a one-time IV bolus injection

Drug: Trans-Sodium Crocetinate

TSC 1.0 mg/kg

EXPERIMENTAL

TSC 1.0 mg/kg given as a one-time IV bolus injection

Drug: Trans-Sodium Crocetinate

TSC 1.5 mg/kg

EXPERIMENTAL

TSC 1.5 mg/kg given as a one-time IV bolus injection

Drug: Trans-Sodium Crocetinate

TSC 2.0 mg/kg

EXPERIMENTAL

TSC 2.0 mg/kg given as a one-time IV bolus injection

Drug: Trans-Sodium Crocetinate

TSC 2.5 mg/kg

EXPERIMENTAL

TSC 2.5 mg/kg given as a one-time IV bolus injection

Drug: Trans-Sodium Crocetinate

Placebo

PLACEBO COMPARATOR

7 mL normal saline given as a one-time IV bolus injection

Drug: Placebo

Interventions

Trans-Sodium Crocetinate DRUG

TSC given as a one-time IV bolus injection

Also known as: TSC

TSC 0.5 mg/kg; TSC 1.0 mg/kg; TSC 1.5 mg/kg; TSC 2.0 mg/kg; TSC 2.5 mg/kg

Placebo DRUG

Placebo normal saline given as a one-time 7 mL one-time IV bolus injection

Also known as: 0.9% Sodium Chloride (NaCl)

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female, age 18-50
• Able and willing to lie quietly supine or semi-recumbent for up to 2.5 hours
• Abstinence from exercise, caffeine, alcohol, nicotine, and a heavy meal prior to testing on the day of the Treatment Visit
• Subject is able to communicate effectively with the Investigator and to comply with all study requirements, restrictions, and directions from the study staff
• Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control (e.g. condom and spermicide), during the study and at least 30 days after the last dose of study drug. Females of non-childbearing potential should be surgically sterile or at least one year post-menopausal.
• Males who engage in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g. condom and spermicide) and agree not to donate sperm during the study and for at least 90 days after the last dose of study drug

You may not qualify if:

• Allergy to study medication
• Pregnant or breastfeeding
• Current smoker and/or any nicotine use within 4 hours of the start of tcpO2 procedures, to include e-cigarette vaping, snuff, chew, nicotine gum and nicotine patches
• Body Mass Index (BMI) \> 30
• Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Antibody (HCVAb)
• Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening
• Plasma donation within 7 days prior to screening
• Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening
• Any skin condition on limbs to be tested that could impair testing (rash, wound, prior radiation therapy, other skin conditions, per Principal Investigator (PI) discretion)
• Known cardiovascular disease, including treated or untreated hypertension
• Significant respiratory disease and/or any other significant medical condition
• Subject has an acute illness (gastrointestinal infection, influenza, or known inflammatory process) at the Treatment Visit
• Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and enrollment)
• Concomitant medications used to treat a diagnosed medical condition
• Subject who, for any reason, is deemed by the Investigator to be unsuitable for the study; or has any condition that would interfere with the evaluation of tissue oxygen measurements or PK of the investigational drug; or is otherwise unable to comply with the protocol

Sponsors & Collaborators

• Diffusion Pharmaceuticals Inc: lead

Study Sites (1)

Altasciences Clinical Kansas Inc

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Interventions

trans-sodium crocetinate; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Limitations of this study include the small sample size and the observed variability across individual TcpO2 sensors that did not allow for pooling of sensor readings for a direct time-matched comparison.

Results Point of Contact

• Title: Chris Galloway, MD (Chief Medical Officer)
• Organization: Diffusion Pharmaceuticals

cgalloway@diffusionpharma.com

(434) 220-0718

Study Officials

• Martin K Kankam, MD, PhD

  Altasciences Clinical Kansas, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: March 17, 2021
• Primary Completion: March 21, 2021
• Study Completion: March 25, 2021
• Last Updated: July 11, 2023
• Results First Posted: July 11, 2023

Record last verified: 2022-08

Locations

US (1)