Phase 1 Study of TIX100 in Healthy Volunteers
This study is testing a drug called TIX100, which is an orally available inhibitor of thioredoxin-interacting protein, in healthy volunteers. We are also using a placebo (an inactive substance that looks like the study drug) for comparison. The main goal is to see how safe TIX100 is, how well your body tolerates it, and how your body processes the drug. We are looking for side effects and changes in lab tests and vital signs (like blood pressure and heart rate) within 7 days. You can join if you are between 18 and 70 years old and are generally healthy. The study is currently unclear about its recruitment status and plans to enroll 35 participants.
- Study design
- This is a Phase 1, single-center, single-dose, randomized, placebo-controlled study. It aims to enroll 35 healthy participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for treatment-related adverse events, laboratory results, and vital signs for 7 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of TIX100 in Healthy Subjects
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0Day 7
- Number of participants with laboratory analyte results above upper limit of normal.Day 7
- Number of participants with vital sign results considered clinically significant by the investigatorDay 7
- Number of participants with ECG results considered clinically significant by the investigatorDay 7
- Number of participants with physical examination findings considered clinically significant by the investigatorDay 7