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

NCT06920901 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: APG777-105
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 11

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.

Conditions

Asthma

Keywords

Asthma; Mild to moderate asthma; Tolerability; Immunogenicity; Pharmacokinetics

Outcome Measures

Primary Outcomes (5)

• Number of Participants with Treatment Emergent Adverse Events (TEAEs)

  Up to 52 weeks

• Number of Participants with Abnormal Laboratory Findings

  Up to 52 weeks

• Number of Participants with Abnormal Vital Signs

  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

Secondary Outcomes (12)

• Maximum concentration (Cmax) of APG777

  Up to 48 weeks

• 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

• Area Under the Serum Concentration-time curve (AUC) from Time 0 to the Last Quantifiable Time Point (AUC0-last)

  Up to 48 weeks

Study Arms (2)

APG777

EXPERIMENTAL

Participants will receive protocol specified dose of APG7777

Drug: APG777

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo

Drug: Placebo

Interventions

APG777 DRUG

APG777 subcutaneous injection

APG777

Placebo DRUG

Matching placebo subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Apogee Therapeutics, Inc.: lead

Study Sites (11)

Investigational Site

La Jolla, California, 92037, United States

Location

Investigational Site

Long Beach, California, 90808, United States

Location

Investigational Site

San Jose, California, 95117, United States

Location

Investigational Site

Torrance, California, 90505, United States

Location

Investigational Site

Normal, Illinois, 61761, United States

Location

Investigational Site

Kansas City, Missouri, 66160, United States

Location

Investigational Site

Edmond, Oklahoma, 73034, United States

Location

Investigational Site

Philadelphia, Pennsylvania, 19140, United States

Location

Investigational Site

Pittsburgh, Pennsylvania, 15241, United States

Location

Investigational Site

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

Location

Investigational Site

Manchester, M23 9QZ, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 10, 2025
• Study Start: March 27, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (9); GB (2)