Phase 1 Study of TVB-3567 for Acne
This study is testing a new oral capsule called TVB-3567 to see how safe it is, how well your body tolerates it, and how it moves through your body (pharmacokinetics or PK). Researchers are also looking at its effects on the body (pharmacodynamics or PD). Some parts of the study will include healthy volunteers, and other parts will include healthy volunteers with moderate to severe acne. The study aims to see if TVB-3567 is safe and well-tolerated. You may be able to join if you are a healthy adult between 18 and 55 years old.
- Study design
- This is a 4-part study with 128 planned participants. It is randomized, meaning you might receive TVB-3567 or a placebo (an inactive capsule), and some parts are double-blind, meaning neither you nor the study team will know which you receive.
- What's involved
- You would take an oral capsule. For some parts, researchers will measure how the drug is absorbed in your body over about 4 days. They will also track any side effects for about 7 to 8 days after you take the medicine.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for 7 to 8 days after you take the study medicine. Drug levels in your body will be measured for up to 4 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.
Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
At a glance
Conditions
Where it's being run
2 sites across 2 statesWho to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs)Baseline to 7 to 8 days after dosing
- Part B - Plasma AUC0-t in fasted and fed conditionsBaseline to Day 4
Area under the concentration-time curve from time zero until the last observed concentration
- Part B - Plasma AUC0-inf in fasted and fed conditionsBaseline to Day 4
Area under the concentration-time curve from time zero to infinity
- Part B - Plasma Cmax in fasted and fed conditionsBaseline to Day 4
Maximum concentration measurement in plasma
- Part B - Incidence of adverse events (AEs) and serious adverse events (SAEs) under fasted and fed conditionsBaseline to 7 to 8 days after dosing
- Part C - Incidence of adverse events (AEs) and serious adverse events (SAEs)Baseline to 13 to 15 days after the last dose
- Part D - Incidence of adverse events (AEs) and serious adverse events (SAEs)Baseline to 13 to 15 days after the last dose