Single Ascending Dose and Multiple Ascending Dose Study of AVR-48
{ "Phase 1 Study of AVR-48 for Safety and Tolerability", "This study is testing a new investigational drug called AVR-48. Researchers want to learn about its safety, how well your body tolerates it, and how it moves through your body (pharmacokinetics). You might receive AVR-48 or a placebo (normal saline, which has no active medicine) through an IV. The study is looking for healthy adults between 18 and 55 years old who are non-smokers. The main goal is to see how many participants experience side effects, serious side effects, or changes in their heart activity (ECG abnormalities) or vital signs up to 16 days after receiving the treatment. The current status of this study is unclear.", "design": "This is a Phase 1, double-blind, randomized, placebo-controlled study with two parts, involving 48 healthy adult volunteers. Participants will receive either AVR-48 or placebo.", "commitments": "You would need to be available for the duration of the study and follow all study procedures. Blood samples will be collected for pharmacokinetic and safety tests, and you will be followed for at least 48 hours post-dose, with safety monitored for up to 16 days.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for safety, including ECG and vital sign abnormalities, for up to 16 days after treatment.", }
- Study design
- Not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Single Ascending Dose and Multiple Ascending Dose Study of AVR-48
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Suchismita Acharya, PhD · STUDY_DIRECTOR · AyuVis Research, Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Number of participants who experience Adverse Events (AEs), Serious Adverse EventsUp to 16 days
Number of AEs, SAEs, and discontinuation due to AEs
- Number of participants who experience ECG abnormalitiesUp to 16 days
Number of participants with potentially clinically significant ECG readings
- Number of participants who experience vital sign abnormalitiesUp to 16 days
Number of participants with potentially clinically significant vital sign values
- Number of participants who experience laboratory test abnormalitiesUp to 16 days
Number of participants with potentially clinically significant laboratory test results
- Number of participants who experience physical examination abnormalitiesUp to 16 days
Number of participants with potentially significant physical examination findings