Search / Trial NCT06617546

SAD and MAD Study of FTX-101 in Healthy Male Subjects

Launched by FIND THERAPEUTICS · Sep 25, 2024

Trial Information

Current as of October 07, 2024

Recruiting

Keywords

Remyelination Myelin Plexin A1 Neuropilin 1

Description

Study Rationale: FTX-101 is a first-in-class, synthetic peptide with a novel mechanism of action designed to promote the self-repair of myelin. FTX-101 is a highly selective modulator of the PlexinA1/Neuropilin 1 receptor system and displays no significant activity on any other target. FTX-101 interferes with the heterodimerization of the coreceptor system and, ultimately, with the activation of second messenger signaling pathways shown to inhibit both the differentiation and migration of oligodendrocyte precursor cells (OPCs) and oligodendrocytes (OLs). Through this mechanism, FTX-101 dis...

Gender

MALE

Eligibility criteria

  • Key Inclusion Criteria:
  • * Willingness to comply with all study procedures and availability for the duration of the study
  • * Healthy adult male
  • * Aged at least 18 years but not older than 59 years
  • * Body mass index (BMI) within 18.5 kg/m\^2 to 32.0 kg/m\^2, inclusively
  • * Non- or ex-smoker
  • * Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG.
  • Key Exclusion Criteria:
  • * Supine or semi-supine pulse rate less than 45 beats per minute (bpm) or more than 100 bpm
  • * Supine or semi-supine blood pressure below 90/50 mmHg
  • * Supine or semi-supine blood pressure higher than 140/90 mmHg
  • * History of significant hypersensitivity to FTX-101 or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
  • * Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
  • * History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
  • * Showing suicidal tendency from 6 months prior to screening
  • * Presence of out-of-range cardiac intervals at screening defined as:
  • * PR \< 110 msec, PR \> 200 msec
  • * QRS \< 60 msec, QRS \>110 msec)
  • * QT Interval Corrected for Heart Rate using Fridericia's Correction Formula (QTcF): • \> 450 msec
  • * History of additional risk factors for torsade's de pointes
  • * Use of concomitant medications that prolong the QT/ corrected QT (QTc) interval
  • * Current use (in the last 6 months) of alcohol (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
  • * Any history of substance or alcohol use disorder within the past 2 years and/or current maintenance therapy (within the past 2 years) for treatment of substance use disorder
  • * Use of any prescription drugs in the 28 days or 5 half-lives, whichever is longer, prior to the first study treatment administration, that in the opinion of an investigator would put into question the status of the participant as healthy
  • * Use of St. John's wort in the 28 days prior to the first study treatment administration
  • * Positive screening results to HIV Ag/Ab combo, hepatitis B surface Ag or hepatitis C virus tests
  • * Intake of an investigational product (IP) in the 28 days prior to the first study treatment administration or within 5 times the elimination half-life of the IP, whichever is longer
  • * Donation of plasma in the 7 days prior to the first study treatment administration
  • * Donation of 1 unit of blood to American Red Cross or equivalent organization or donation of over 500 mL of blood in the 56 days prior to the first study treatment administration

About Find Therapeutics

Find Therapeutics is a biopharmaceutical company dedicated to advancing innovative therapies for patients with unmet medical needs. With a focus on precision medicine, the company employs cutting-edge research and development strategies to discover and develop novel treatments for complex diseases. Committed to rigorous clinical testing and ethical standards, Find Therapeutics collaborates with leading academic institutions and industry partners to accelerate the translation of scientific discoveries into effective therapeutic solutions. Through its patient-centric approach, Find Therapeutics aims to improve health outcomes and enhance the quality of life for individuals suffering from challenging medical conditions.

Locations

Overland Park, Kansas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0