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

Phase 1

Recruiting

• Conditions: Asthma
• Interventions: Drug: APG777; Drug: Placebo

• Registration Number: NCT06920901
• Lead Sponsor: Apogee Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-27
• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-04-08
• Study First Posted: 2025-04-10
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-13
• Primary Completion: 2026-09
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APG777	APG777	Participants will receive protocol specified dose of APG7777
Placebo	Placebo	Participants will receive matching placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants with Abnormal Laboratory Findings	Up to 52 weeks
Number of Participants with Abnormal Electrocardiograms (ECGs)	Up to 52 weeks
Number of Participants with Abnormal Physical Examination Findings	Up to 52 weeks
Number of Participants with Abnormal Vital Signs	Up to 52 weeks
Number of Participants with Treatment Emergent Adverse Events (TEAEs)	Up to 52 weeks

Secondary Outcome Measures

Name	Time	Method
Time to reach Cmax (tmax)	Up to 48 weeks
Terminal elimination rate constant (λz)	Up to 48 weeks
Terminal Elimination half-life (t1/2)	Up to 48 weeks
Number of Participants with Anti-Drug-Antibodies (ADAs)	Up to 48 weeks
Cmax in Participants With and without ADAs	Up to 48 weeks
AUClast Participants With and without ADAs	Up to 48 weeks
AUCInf Participants With and without ADAs	Up to 48 weeks
Maximum concentration (Cmax) of APG777	Up to 48 weeks
Area Under the Serum Concentration-time curve (AUC) from Time 0 to the Last Quantifiable Time Point (AUC0-last)	Up to 48 weeks
AUC From Time 0 Extrapolated to Infinity (AUC0-inf)	Up to 48 weeks
Apparent Clearance of APG777 (CL/F)	Up to 48 weeks
Apparent Volume of Distribution (Vz/F)	Up to 48 weeks

Trial Locations

Locations (1)

Investigational Site; 🇬🇧 Manchester, United Kingdom