Table of contents
- Trial overview
- Who can participate
- Study design and phase
- What the trial measures
- Why this trial matters
Trial overview
The main clinical trial listed for Wve-006 is NCT06405633, an authorised interventional study in people with Pi*ZZ alpha-1 antitrypsin deficiency (AATD).[1] The study title says it is a Phase 1b/2a, open-label single ascending doses and multiple ascending doses study, and the trial record also lists it as Phase 1.[1] The brief summary says the goal is to evaluate the safety and tolerability of Wve-006 in participants with Pi*ZZ AATD.[1]
Who can participate
This study is for participants with Pi*ZZ AATD, which is a specific form of alpha-1 antitrypsin deficiency.[1] In simple terms, the trial is not for the general public; it is focused on people who have this exact condition.[1] The enrollment goal is 29 participants, so this is a small early study.[1]
Study design and phase
The study is open-label, which means the researchers and participants know what treatment is being given.[1] It includes single ascending doses and multiple ascending doses, which means the study looks at one dose first and then may test higher doses, and it also checks repeated dosing over time.[1] These are common early-study steps used to learn how a treatment behaves in people before larger studies are done.[1]
What the trial measures
The primary outcome is the proportion of participants with adverse events.[1] Adverse events are unwanted medical problems that happen during a study, whether or not they are caused by the treatment.[1] This endpoint helps researchers understand the safety profile of Wve-006 in the study group.[1]
Why this trial matters
Because this is an early-phase study, it is mainly about learning whether Wve-006 can be studied safely in people with Pi*ZZ AATD.[1] The trial does not provide final proof that the treatment works, but it is an important first step for understanding safety and tolerability in the target population.[1]
