FTX-101 for Healthy Subjects

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

80 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug FTX-101?

Patient-reported outcomes (PROs) are important for understanding how new drugs impact patients' lives, and they are increasingly used in drug development to measure effectiveness. Although specific data on FTX-101 is not provided, PROs have been shown to be valuable in assessing the impact of treatments in various therapeutic areas, which may suggest potential benefits for FTX-101 as well. ^{1 2 3 4 5}

What safety data exists for FTX-101 in humans?

The available research highlights the importance of careful safety assessments in early human trials, as serious adverse events have occurred in some first-in-human studies. However, specific safety data for FTX-101 is not provided in the available research articles. ^{6 7 8 9 10}

What is the purpose of this trial?

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

Research Team

Martin K Kankam

Principal Investigator

Altasciences Clinical Kansas, Inc.

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Patient reported outcomes: looking beyond the label claim. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Netherlands pubmed.ncbi.nlm.nih.gov

The use of cognitive interviews to revise the Quality of Trauma Care Patient-Reported Experience Measure (QTAC-PREM). [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Measuring What Matters: Patient-Reported Outcome and Experience Measures for Men Undergoing Radical Prostatectomy. [2022]

6. Germany 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. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Implications of the BIA-102474-101 study for review of first-into-human clinical trials. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]

9. Switzerland 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". [2020]

10. England pubmed.ncbi.nlm.nih.gov

Legacy data sharing to improve drug safety assessment: the eTOX project. [2022]