New asthma drug enters early human testing
NCT ID NCT06920901
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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31 people
The number who actually took part.
- Started
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Mar 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Investigational Site
La Jolla, California, 92037, United States
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Investigational Site
Long Beach, California, 90808, United States
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Investigational Site
San Jose, California, 95117, United States
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Investigational Site
Torrance, California, 90505, United States
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Investigational Site
Normal, Illinois, 61761, United States
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Investigational Site
Kansas City, Missouri, 66160, United States
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Investigational Site
Edmond, Oklahoma, 73034, United States
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Investigational Site
Philadelphia, Pennsylvania, 19140, United States
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Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
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Investigational Site
Bradford, West Yorkshire, BD9 6RJ, United Kingdom
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Investigational Site
Manchester, M23 9QZ, United Kingdom
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