FTX-101 for Healthy Subjects

No longer recruiting at 1 trial location

Overseen By Violetta Dimitriadou, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Phase 1

Sponsor: Find Therapeutics

Must not be taking: QT prolonging drugs, St. John's wort

Disqualifiers: Cardiovascular, Gastrointestinal, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called FTX-101 to assess its safety and how the body processes it. Healthy male participants will receive either a single dose or multiple doses over 14 days, compared to a placebo (an inactive substance). Ideal candidates are healthy men who do not smoke and have no significant medical issues. The trial aims to gather initial data on FTX-101's effects before further studies. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription drugs at least 28 days before the study starts, unless the investigator believes it won't affect your health status. Also, you should not use St. John's wort in the 28 days before the study.

Is there any evidence suggesting that FTX-101 is likely to be safe for humans?

Research has shown that FTX-101 is being tested for human safety. This first study involving people aims to understand how well individuals tolerate FTX-101 at different doses. As a Phase 1 study, the primary focus is on safety.

While specific safety data for FTX-101 is not yet available, this Phase 1 trial marks the first time the treatment is tested in humans. Researchers closely monitor for any side effects or adverse reactions. In similar early studies, small doses are typically administered initially, with gradual increases to observe responses.

It is important to note that a reference mentioned a first-in-human trial (not involving FTX-101) where serious side effects, including one death, occurred. This underscores the importance of safety monitoring in Phase 1 trials. Although this does not directly relate to FTX-101, it highlights the careful steps involved in testing new treatments.

Overall, the current phase of the trial indicates that researchers are primarily focused on ensuring FTX-101's safety before evaluating its efficacy. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about FTX-101 because it introduces a new approach to treatment with its unique delivery method and dosage flexibility. Unlike traditional medications that might require oral administration or intravenous methods, FTX-101 is delivered through subcutaneous injections, which can be more convenient and less invasive. Additionally, it offers versatility with both single and multiple daily dosing options, potentially enhancing patient adherence and allowing for tailored treatment plans. This innovative approach could lead to more efficient and patient-friendly therapies.

What evidence suggests that FTX-101 could be effective?

FTX-101 is a new treatment undergoing testing to determine its safety and tolerability in healthy men. Currently, limited information exists on its effectiveness for any specific health condition, as this is an early-stage trial. The study primarily aims to understand the drug's action in the body and assess its safety. Since FTX-101 remains in the initial testing phase, it is too early to determine its effectiveness for treating any particular health issue. The research focuses on ensuring the drug's safety and understanding its effects in healthy individuals. ^{1 2 4 5 6}

Who Is on the Research Team?

Martin K Kankam

Principal Investigator

Altasciences Clinical Kansas, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy male subjects who want to participate in a study testing a new medication, FTX-101. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and cannot have conditions that would exclude them from safely participating.

Inclusion Criteria

Body mass index (BMI) within 18.5 kg/m^2 to 32.0 kg/m^2, inclusively

Non- or ex-smoker

Willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

Showing suicidal tendency from 6 months prior to screening

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

My resting heart rate is either below 45 or above 100 bpm.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Single Ascending Dose (SAD)

Participants receive a single subcutaneous dose of FTX-101 or placebo in a 3:1 ratio across multiple cohorts

2 weeks

Multiple visits for dosing and monitoring

Multiple Ascending Dose (MAD)

Participants receive multiple subcutaneous doses of FTX-101 or placebo in a 3:1 ratio for 14 days

4 weeks

Frequent visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2-3 visits for follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• FTX-101

Trial Overview The trial is evaluating the safety and dosage of FTX-101 compared to a placebo. It's divided into two parts: Part A tests single doses (SAD) with an additional test for how much drug gets into the bloodstream, while Part B examines the effects of multiple doses (MAD).

How Is the Trial Designed?

Group I: Part B (MAD): Cohort B4 Experimental Treatment 2 Interventions

Optional cohort to receive once daily dose (as 1 or 2 SC injection\[s\]) of FTX-101 or placebo for 14 days in a 3:1 ratio

Group II: Part B (MAD): Cohort B3 Experimental Treatment 2 Interventions

Once daily dose (as 1 or 2 SC injection\[s\]) of FTX-101 or placebo for 14 days in a 3:1 ratio

Group III: Part B (MAD): Cohort B2 Experimental Treatment 2 Interventions

Once daily dose (as 1 or 2 SC injection\[s\]) of FTX-101 or placebo for 14 days in a 3:1 ratio

Group IV: Part B (MAD): Cohort B1 Experimental Treatment 2 Interventions

Once daily dose (as 1 or 2 SC injection\[s\]) of FTX-101 or placebo for 14 days in a 3:1 ratio

Group V: Part A (SAD): Cohort A6 Experimental Treatment 2 Interventions

Optional cohort to receive additional single ascending intermediate (lower) or equivalent dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio

Group VI: Part A (SAD): Cohort A5 Experimental Treatment 2 Interventions

Single dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio

Group VII: Part A (SAD): Cohort A4 Experimental Treatment 2 Interventions

Single dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio

Group VIII: Part A (SAD): Cohort A3 Experimental Treatment 2 Interventions

Single dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio

Group IX: Part A (SAD): Cohort A2 Experimental Treatment 2 Interventions

Single dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio

Group X: Part A (SAD): Cohort A1 Experimental Treatment 2 Interventions

Single dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio

Who Is Running the Clinical Trial?

Find Therapeutics

Lead Sponsor

Trials

1

Recruited

80+

Published Research Related to This Trial

The first-in-human clinical trial of BIA 10-2474 resulted in serious adverse events for 6 healthy volunteers, including 1 death, highlighting the heightened risks associated with novel investigational drugs transitioning from animal studies to human trials.

The symposium emphasized the need for careful planning and communication in clinical trials to minimize risks to participants, suggesting that a complex matrix of factors must be considered to ensure safety and integrity in first-in-human studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety in FIH Trials: A Summary of the Symposium "Fatal Drug Trial in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost". Greenberg, HE., van Iersel, MT., Westrick, ML., et al.[2020]

The eTOX project aims to enhance early drug safety assessments by sharing legacy preclinical safety data among pharmaceutical companies, which could lead to better-informed decision-making in drug development.

Integrating shared safety data with other information sources presents a unique opportunity to improve the overall safety evaluation process for new medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Legacy data sharing to improve drug safety assessment: the eTOX project. Sanz, F., Pognan, F., Steger-Hartmann, T., et al.[2022]

In a review of 24 First-in-Man studies involving 1,017 healthy male volunteers, the incidence of adverse events (AEs) was low, with 98.3% of AEs being mild or moderate, indicating a favorable safety profile for small molecules in Phase I trials.

Only 0.4% of treatments resulted in serious adverse events, all of which were not medically concerning and did not require hospitalization, suggesting that small molecule trials can be conducted safely in healthy volunteers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of healthy volunteers in First-in-Man trials - an analysis of studies conducted at the Bayer in-house ward from 2000 to 2005. Wensing, G., Ighrayeb, IA., Boix, O., et al.[2019]

The recent fatal adverse event in the BIA-102474-101 clinical trial highlights significant limitations in the current safety review process for first-into-human trials, despite previous trials with similar compounds being conducted without incident.

To improve safety in future trials, it is crucial to implement sequential dosing strategies, thorough reviews of preclinical toxicity studies, and systematic risk assessments, especially for novel compounds that may pose higher risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implications of the BIA-102474-101 study for review of first-into-human clinical trials. Eddleston, M., Cohen, AF., Webb, DJ.[2021]

In a comprehensive review of 54 phase-I studies involving 1015 healthy volunteers over 10 years, the overall incidence of adverse events was found to be 12.8%, with a higher rate for active drugs (13.7%) compared to placebo (7.9%).

Most adverse events were minor, with only 3% classified as severe, and no deaths or life-threatening events reported, highlighting that while adverse events are common in phase-I trials, they are typically not serious.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. Sibille, M., Deigat, N., Janin, A., et al.[2019]

Patient-reported outcomes (PROs) are increasingly recognized as valuable measures of how new drug treatments affect patients, and their inclusion in drug development can influence approval and labeling processes.

A study found that PRO data were included in 30% of new drug labels, particularly in areas like anti-inflammatory and respiratory treatments, highlighting the importance of these outcomes in communicating treatment effectiveness to stakeholders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the value of treatment to patients: patient-reported outcomes in drug development. Willke, RJ.[2021]

Patient-reported outcome and experience measures are essential for accurately reflecting a patient's functional outcomes and quality of life.

For these measures to be effective, they must be easily understandable and accessible to patients and healthcare providers, highlighting the need for physician involvement in their development and implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring What Matters: Patient-Reported Outcome and Experience Measures for Men Undergoing Radical Prostatectomy. Labban, M., Briggs, L., Cole, AP., et al.[2022]

Patient-reported outcome scales are increasingly used in clinical trials for chronic conditions, providing essential data that complements traditional clinical evidence and helps demonstrate a product's effectiveness in improving quality of life.

These outcomes are valuable not only for securing regulatory claims in the US and Europe but also for influencing pricing and availability decisions made by regulatory authorities, payers, clinicians, and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported outcomes: looking beyond the label claim. Doward, LC., Gnanasakthy, A., Baker, MG.[2022]

Cognitive interviews with 30 participants (17 injured patients and 13 family members) revealed significant issues with the original 'Quality of Trauma Care Patient-Reported Experience Measure', leading to the deletion of 39 items and the addition of 28 new items, resulting in a final instrument of 63 items.

Key findings indicated that many participants struggled to evaluate the quality of care received in pre-hospital and emergency department settings, highlighting the need for improved methods to assess these phases of trauma care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of cognitive interviews to revise the Quality of Trauma Care Patient-Reported Experience Measure (QTAC-PREM). Bobrovitz, N., Santana, MJ., Kline, T., et al.[2018]

Patient-reported outcome measures (PROMs) are crucial for accurately capturing patient symptoms and quality of life, which can enhance the robustness of clinical research and improve patient outcomes.

Incorporating PROMs in clinical trials helps reduce observer bias and actively engages patients in the research process, while also providing valuable insights for health service planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to Include Patient-Reported Outcome Measures in Clinical Trials. McGee, RG.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06617546

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

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-9-2024-44a90

FTX-101 for Healthy Subjects · Info for Participants This Phase 1 medical study run by Find Therapeutics needs participants to evaluate whether FTX-101 will have tolerable side effects & efficacy for patients ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/find-therapeutics-trial-dosing/

Find Therapeutics dosing subjects in study of FTX-101 ... The study aims to evaluate the safety, tolerability and pharmacokinetics of FTX-101 versus placebo in healthy volunteers. Find Therapeutics ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06617546/sad-and-mad-study-of-ftx-101-in-healthy-male-subjects

SAD and MAD Study of FTX-101 in Healthy Male Subjects This is a Phase 1, first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled study in healthy male subjects.

5. synapse.patsnap.com synapse.patsnap.com/drug/87d39582ff1d4e5183a3b9955875441d

FTX-101(Find Therapeutics) - Drug Targets, Indications, ... A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study to Assess Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and ...

6. findtherapeutics.com findtherapeutics.com/ftx-101-phase-1-clinical-trial-launched/

FTX-101 Phase 1 Clinical Trial Launched The Phase 1 first-in-human study will assess the safety, tolerability, and pharmacokinetics of FTX-101 when administered in healthy volunteers.