Testing FTX-101 in healthy male volunteers
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
This study is testing a new drug called FTX-101 in healthy men to see how it affects the body and if it can help repair nerve damage.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | Male |
| Sponsor | Find Therapeutics Industry-sponsored |
| Locations | 1 site (Overland Park, Kansas) |
| Trial ID | NCT06617546 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial evaluates FTX-101, a synthetic peptide aimed at promoting myelin self-repair, in healthy male subjects. The study consists of two parts: a Single Ascending Dose (SAD) and a Multiple Ascending Dose (MAD) to assess the safety, tolerability, and pharmacokinetics of FTX-101. Participants will receive either the drug or a placebo, and the study will also investigate the immunogenic potential of FTX-101 and its effects on heart function. The goal is to understand how FTX-101 interacts with the body and its potential to aid in remyelination processes.
Who should consider this trial
Good fit: Ideal candidates are healthy adult males aged 18 to 59 with a BMI between 18.5 and 32.0.
Not a fit: Patients with significant health issues or those outside the specified age and BMI range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatments that enhance myelin repair, potentially benefiting patients with demyelinating conditions.
How similar studies have performed: While this approach is novel, similar studies targeting remyelination have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Overland Park, Kansas
- Altasciences Clinical Kansas, Inc. — Overland Park, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Martin K. Kankam, MD, PhD, MPH, FAPCR — Altasciences Clinical Kansas, Inc.
- Study coordinator: Robert L. Glanzman, MD, FAAN
- Email: rglanzman@findtherapeutics.com
- Phone: (415) 535 9032
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.