A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Immunogenicity of APG777… (NCT06920901) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Immunogenicity of APG777 in Adults With Asthma
United States31 participantsStarted 2025-03-27
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
What they're measuring
1
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to 52 weeks
2
Number of Participants with Abnormal Laboratory Findings
Timeframe: Up to 52 weeks
3
Number of Participants with Abnormal Vital Signs
Timeframe: Up to 52 weeks
4
Number of Participants with Abnormal Electrocardiograms (ECGs)
Timeframe: Up to 52 weeks
5
Number of Participants with Abnormal Physical Examination Findings