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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-27

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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APG777

Participants will receive protocol specified dose of APG7777

Group Type EXPERIMENTAL

APG777

Intervention Type DRUG

APG777 subcutaneous injection

Placebo

Participants will receive matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo subcutaneous injection

Interventions

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APG777

APG777 subcutaneous injection

Intervention Type DRUG

Placebo

Matching placebo subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No