FTX-101 for Healthy Subjects
What You Need to Know Before You Apply
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
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 safety data exists for FTX-101 in humans?
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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Ascending Dose (SAD)
Participants receive a single subcutaneous dose of FTX-101 or placebo in a 3:1 ratio across multiple cohorts
Multiple Ascending Dose (MAD)
Participants receive multiple subcutaneous doses of FTX-101 or placebo in a 3:1 ratio for 14 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FTX-101
Find a Clinic Near You
Who Is Running the Clinical Trial?
Find Therapeutics
Lead Sponsor