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New asthma drug enters early human testing

NCT ID NCT06920901

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug called APG777 in 31 adults with mild-to-moderate asthma. The main goal is to check if the drug is safe and how the body handles it. Participants receive either the drug or a placebo, and researchers monitor for side effects and measure drug levels in the blood over about a year.

Why investors are watching

Apogee Therapeutics is testing APG777, an experimental drug, in a small phase 1b trial with 31 adults who have mild-to-moderate asthma. The study measures safety, how the body processes the drug, and immune reactions over about a year. For a small company, this early readout matters because it is the first test of whether the drug is safe enough to keep developing.

If it works: If the trial shows APG777 is safe and well-tolerated, Apogee could move the drug into larger studies. That progress could support the company's pipeline value.

If it fails: Phase 1 trials often fail on safety or tolerability, and this one has only 31 participants, so results may not predict success in a larger group. A failure or delay could set back Apogee's development plans and hurt its stock.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

31 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have a diagnosis of mild-to-moderate asthma (Global Initiative for Asthma 2023 criteria) ≥ 1 year prior to Screening * Maintain FeNO-high (≥ 25 parts per billion \[ppb\]) or FeNO-low (\< 25 ppb) status from Screening to Day 1 prior to Randomization * Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 60% of predicted normal value at Screening * Asthma Control Test (ACT) score \> 19 at Screening * Maintained control on as-needed short-acting beta-agonist (SABA) +/- stable dose inhaled corticosteroids (ICS) or stable dose of ICS/ long-acting beta-agonist (LABA); +/- stable dose leukotriene receptor antagonist (LTRA). ICS dose should be stable for ≥ 12 weeks prior to Day 1, LTRA dose should be stable for ≥ 8 weeks prior to Day 1 * Women of childbearing potential and male participants to use a highly effective form of contraception Exclusion Criteria: * Any asthma exacerbation requiring systemic corticosteroids within 12 weeks of Screening and/or any asthma exacerbation that resulted in overnight hospitalization within 6 months prior to Screening * Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia * History of biologics use for treatment or control of asthma * Current smokers or participants with a smoking history of ≥ 10 pack years * Known history of illicit drug abuse, harmful alcohol use Note: Other protocol defined criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Investigational Site

    La Jolla, California, 92037, United States

  • Investigational Site

    Long Beach, California, 90808, United States

  • Investigational Site

    San Jose, California, 95117, United States

  • Investigational Site

    Torrance, California, 90505, United States

  • Investigational Site

    Normal, Illinois, 61761, United States

  • Investigational Site

    Kansas City, Missouri, 66160, United States

  • Investigational Site

    Edmond, Oklahoma, 73034, United States

  • Investigational Site

    Philadelphia, Pennsylvania, 19140, United States

  • Investigational Site

    Pittsburgh, Pennsylvania, 15241, United States

  • Investigational Site

    Bradford, West Yorkshire, BD9 6RJ, United Kingdom

  • Investigational Site

    Manchester, M23 9QZ, United Kingdom

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