NCT06920901Active, not recruitingPhase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Immunogenicity of APG777 in Adults With Asthma
A Phase 1b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of APG777 in Adults With Mild-to-Moderate Asthma
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and immunogenicity of APG777 in adult participants with mild-to-moderate asthma. The duration of the study will be approximately 52 weeks (364 days) for each participant and will consist of a Screening Period, Treatment Period, and Follow-up Period.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 27 Mar 2025
- Start date
- 27 Mar 2025
- Primary completion date
- 17 Sept 2026
- Lead sponsor
- Apogee Therapeutics, Inc.
- Diseases
- Asthma
- NCT number
- NCT06920901
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 31
- From 27 Mar 2025 to the primary completion date, 17 Sept 2026
- 11 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Bradford | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Edmond | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| - Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Normal | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| - Coordinator of this site? Confirm its status | San Jose | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
Related publications
- A First-in-Human, Single- and Multiple-Dose Study of APG777, a Half-Life-Extended Anti-IL-13 Monoclonal Antibody, in Healthy Volunteers.Clin Transl Sci · 2025 · PMID 41422501
This page is information, not medical advice. Discuss any trial with your doctor.