TERMINATED

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

Conditions

Healthy Volunteers remyelination myelin plexin A1 neuropilin 1

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 1, first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled study in healthy male subjects. The study will include the following 2 parts: * Part A: Single Ascending Dose (SAD) in healthy male subjects * Part B: Multiple Ascending Dose (MAD) in healthy male subjects

Official Title

A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study to Assess Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of FTX-101 After Subcutaneous Injection of FTX-101 in Healthy Male Subjects

Quick Facts

Study Start:2024-10-14

Study Completion:2025-04-17

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT06617546

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.

Ages Eligible for Study:18 Years to 59 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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 150/95 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

Inclusion Criteria

Exclusion 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.

* 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 150/95 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

Contacts and Locations

Principal Investigator

Martin K. Kankam, MD, PhD, MPH, FAPCR

PRINCIPAL_INVESTIGATOR

Altasciences Clinical Kansas, Inc.

Study Locations (Sites)

Altasciences Clinical Kansas, Inc.

Overland Park, Kansas, 66212

United States

Collaborators and Investigators

Sponsor: Find Therapeutics

Martin K. Kankam, MD, PhD, MPH, FAPCR, PRINCIPAL_INVESTIGATOR, Altasciences Clinical Kansas, Inc.

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 Registration Dates

Study Start Date2024-10-14

Study Completion Date2025-04-17

Study Record Updates

Study Start Date2024-10-14

Study Completion Date2025-04-17

Terms related to this study

Keywords Provided by Researchers

remyelination
myelin
plexin A1
neuropilin 1

Additional Relevant MeSH Terms

Healthy Volunteers