All studies
Active not recruitingPHASE1INTERVENTIONAL

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Immunogenicity of APG777 in Adults With Asthma

This study is investigating a new potential treatment called APG777 for adults who have mild to moderate asthma. It's a Phase 1 clinical trial, which means the main goal is to check if the drug is safe and well-tolerated, as well as how it moves through and is processed by the body. Researchers will also look at the body's immune response to APG777. Participants will be randomly assigned to receive either APG777 or a placebo (a treatment with no active drug) without knowing which one they are getting. The study will last about 52 weeks (just under a year) for each person, including initial checks, the treatment period, and a follow-up.

At a glance

Status
Active not recruiting
Phase
PHASE1
Sponsor
Apogee Therapeutics, Inc.
Enrolment target
31
Start
27 Mar 2025
Estimated completion
01 Mar 2027

What is this study about?

This research study is about a new drug called APG777 that doctors hope might help people with asthma. Before any new medication can become widely available, it has to go through several stages of testing to make sure it's safe and effective. This particular study is an early stage (Phase 1) trial. This means the researchers' main focus is to understand if APG777 is safe for people to take, what side effects it might cause, and how the body processes the medication.

Participants in the study will be adults with mild to moderate asthma. They will be randomly put into one of two groups: one group will receive APG777, and the other will receive a placebo. A placebo looks just like the real drug but contains no active medicine. Neither you nor your study doctor will know which you are receiving – this is called "double-blind." This helps to make sure the results are as fair and accurate as possible.

The information gathered from this study will be crucial for deciding whether APG777 has the potential to be a future treatment for asthma and whether it's safe enough to move on to larger and more advanced testing phases. Your participation could help advance our understanding of new ways to manage asthma.

Key takeaways

  • This study is for adults (18-65) with mild to moderate asthma.
  • It's testing a new drug called APG777, mainly for safety.
  • You might receive the new drug or a dummy pill (placebo).
  • The study lasts about one year with regular check-ups.
  • Your current asthma must be reasonably controlled.
  • You can stop participating at any point if you wish.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old and have been diagnosed with mild to moderate asthma for at least a year. Your asthma should be reasonably controlled with your current medications, which might include an occasional reliever inhaler, regular preventative inhalers, or other asthma medicines. We'll also check your lung function (how well you can breathe out) and your asthma control score.

There are also some reasons why you might not be able to join. For example, if you've had a severe asthma attack that needed strong steroid tablets or hospital care recently, or if you've ever had a life-threatening asthma attack. You also can't have used certain newer asthma treatments called biologics. If you currently smoke or have smoked a lot in the past (defined as 10 'pack years' or more), or if you have a history of drug or alcohol misuse, you wouldn't be able to take part. Also, women who could become pregnant and men must agree to use effective contraception during the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 65 years old?
  2. Have you had mild-to-moderate asthma for at least a year?
  3. Is your asthma currently reasonably controlled on usual medications?
  4. Have you avoided steroid tablets or hospital stays for asthma in the last 12 weeks?
  5. Are you not currently a heavy smoker (or haven't been in the past)?
  6. Are you willing to use effective birth control if applicable?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last about 52 weeks (just under a year). You'll first go through a 'screening period' to make sure the study is right for you. This will involve health checks, reviewing your medical history, and some tests. If you're eligible, you'll then enter the 'treatment period' where you'll receive either the study drug (APG777) or the placebo. This will involve regular visits to the clinic for assessments, blood tests, and to receive your medication. After the treatment period, there will be a 'follow-up period' to continue monitoring your health and any effects of the study drug.

Potential risks and benefits

Taking part in a clinical trial may offer the potential benefit of trying a new medication that could help your asthma, which might not be available otherwise. However, there's no guarantee that you'll receive the active drug or that it will help your condition. There may also be risks, including side effects from the medication, which could be mild or more serious, or discomfort from medical procedures like blood tests. Your health and safety are very important, and you will be closely monitored throughout the study. You also have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Investigational Site
    Verified postcode
    La Jolla, United States
  • Investigational Site
    Verified postcode
    Long Beach, United States
  • Investigational Site
    Verified postcode
    San Jose, United States
  • Investigational Site
    Verified postcode
    Torrance, United States
  • Investigational Site
    Verified postcode
    Normal, United States
  • Investigational Site
    Verified postcode
    Kansas City, United States
  • Investigational Site
    Verified postcode
    Edmond, United States
  • Investigational Site
    Verified postcode
    Philadelphia, United States
  • Investigational Site
    Verified postcode
    Pittsburgh, United States
  • Investigational Site
    Verified postcode
    Bradford, United Kingdom
  • Investigational Site
    Verified postcode
    Manchester, United Kingdom

Common questions

What is a Phase 1 study?

A Phase 1 study is an early stage of clinical research. Its main purpose is to check if a new medication is safe for people and how the body handles it.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real drug but doesn't contain any active medicine. It helps researchers compare how well the real drug works.

How long will the study last for me?

Each participant will be in the study for about 52 weeks, which is just under one year.

Will I know if I'm getting the real drug or the placebo?

No, neither you nor your study doctor will know if you're receiving APG777 or the placebo. This is called a 'double-blind' study and helps keep the results unbiased.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, and it won't affect your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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