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FTX-101 for Healthy Subjects
Phase 1
Recruiting
Led By Martin K. Kankam, MD, PhD, MPH, FAPCR
Research Sponsored by Find Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged at least 18 years but not older than 59 years
Healthy adult male
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a (sad): days 1, 2, 4, and 15; part a (ba): days 1, 2, 4, 15, 16, 18, and 29; part b (mad): days 1, 2, 5, 9, 14, 15, 17, and 29
Summary
This trial is the first time a new drug is being tested in humans. It will involve healthy male participants and has two parts: - Part A will involve giving a single dose of the drug and
Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
Since this is a first-in-human study for FTX-101, potential side effects are unknown but will be closely monitored. Placebo, which has no active ingredients, typically does not cause side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 59 years old.
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I am a healthy adult male.
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I don't have any significant health issues apart from my current condition.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My resting heart rate is either below 45 or above 100 bpm.
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My blood pressure is lower than 90/50 mmHg when lying down.
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My blood pressure is over 140/90 mmHg when lying down.
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My heart's electrical activity is within normal ranges and I don't take medications that affect it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ part a (sad): days 1, 2, 4, and 15; part a (ba): days 1, 2, 4, 15, 16, 18, and 29; part b (mad): days 1, 2, 5, 9, 14, 15, 17, and 29
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a (sad): days 1, 2, 4, and 15; part a (ba): days 1, 2, 4, 15, 16, 18, and 29; part b (mad): days 1, 2, 5, 9, 14, 15, 17, and 29
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Columbia Suicide Severity Rating Scale (C-SSRS) score
Frequency of adverse events
Frequency of injection site reactions
+6 moreSecondary study objectives
Absolute bioavailability of FTX-101 [Part A (BA)]
Plasma AUC0-24 (Part B MAD)
Plasma AUC0-last
+22 moreTrial Design
10Treatment groups
Experimental Treatment
Group I: Part B (MAD): Cohort B4Experimental Treatment2 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 B3Experimental Treatment2 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 B2Experimental Treatment2 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 B1Experimental Treatment2 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 A6Experimental Treatment2 Interventions
Optional cohort to receive additional single ascending intermediate (lower) or equivalent dose of FTX-101 or placebo in a 3:1 ratio via SC injection
Group VI: Part A (SAD): Cohort A5Experimental Treatment2 Interventions
Single dose (as 1 or 2 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio
Group VII: Part A (SAD): Cohort A4Experimental Treatment2 Interventions
Single dose (as 1 or 2 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio
This Cohort may include a nested Absolute Bioavailability Cohort. After the SC dose, there will be a 14-day washout period and a single intravenous infusion of FTX-101 or placebo will be administered.
Group VIII: Part A (SAD): Cohort A3Experimental Treatment2 Interventions
Single dose (as 1 or 2 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio
This Cohort may include a nested Absolute Bioavailability Cohort. After the SC dose, there will be a 14-day washout period and a single intravenous infusion of FTX-101 or placebo will be administered.
Group IX: Part A (SAD): Cohort A2Experimental Treatment2 Interventions
Single dose (as 1 or 2 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio
This Cohort may include a nested Absolute Bioavailability Cohort. After the SC dose, there will be a 14-day washout period and a single intravenous infusion of FTX-101 or placebo will be administered.
Group X: Part A (SAD): Cohort A1Experimental Treatment2 Interventions
Single dose (as 1 or 2 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Find TherapeuticsLead Sponsor
Martin K. Kankam, MD, PhD, MPH, FAPCRPrincipal InvestigatorAltasciences Clinical Kansas, Inc.
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