None listed
Conditions
Brief summary
The main aim of the study is to evaluate the safety and tolerability of single doses of APG808 in healthy participants, and multiple doses of APG808 in patients with mild-to-moderate asthma.
Interventions
This study will evaluate single ascending doses (SAD) of APG808 administered subcutaneously (SC) in healthy participants and multiple doses (MD) in patients with mild-to-moderate asthma. The SAD portion will consist of a maximum of 4 cohorts and each cohort will consist of up to 8 healthy participants. In the SAD portion, participants will be randomized 6:2 to APG808 or placebo (up to 32 participants total) in 1 of the 4 treatment cohorts.
Cohort 1 - APG808 Dose 150 milligram (mg) or placebo
Co
This study will evaluate single ascending doses (SAD) of APG808 administered subcutaneously (SC) in healthy participants and multiple doses (MD) in patients with mild-to-moderate asthma. The SAD portion will consist of a maximum of 4 cohorts and each cohort will consist of up to 8 healthy participants. In the SAD portion, participants will be randomized 6:2 to APG808 or placebo (up to 32 participants total) in 1 of the 4 treatment cohorts. Cohort 1 - APG808 Dose 150 milligram (mg) or placebo Cohort 2 - APG808 Dose 300 mg or placebo Cohort 3 - APG808 Dose 600 mg or placebo Cohort 4 - APG808 Dose 1200 mg or placebo For the MD cohort (Cohort 5), dosing is planned on Days 1 and 29. In the MD cohort, approximately 20 patients will be randomized 3:1 to APG808 (600 mg per dose) or placebo. The study will be conducted at multiple sites in Australia. The anticipated study duration for any individual participant in the SAD portion is up to approximately 210 days, including screening. The anticipated study duration for any individual patient in the MD cohort is up to approximately 238 days, including screening.
Sponsors
Apogee Therapeutics, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
For SAD cohorts- 1. Healthy men and women, in the opinion of the Investigator and as determined by physical examination, laboratory screening tests, and medical history 2. 18 to 65 years of age with a body mass index of 18 to 35 kg/m^2 (kilogram per square meter), and weight <120 kg 3. Willing to use a highly effective method of contraception from admission through 30 days after EOS (end of the study) or 5 half-lives after the last administration of study drug, whichever is longer 4. Willing to abstain from regular, continuous alcohol use (defined as an average of >10 standard drinks per week or at the Investigator's discretion) or tobacco use (defined as >=5 cigarettes per day or equivalent) for 48 hours prior to admission to the CRU (Day -1) and any illicit drug abuse for >=48 hours prior to admission to the CRU (Day -1) For MD cohort- 1. 18 to 65 years of age with a body mass index of 18 to 35 kg/m^2 and weight <120 kg 2. Physician diagnosis of mild or moderate asthma (as defined by Global Initiative for Asthma [GINA 2023]) >=1 year prior to Screening, and as determined by the Investigator through patient interview and/or review of medical history 3. Fractioned exhaled nitric oxide (FeNO) of >=25 parts per billion (ppb) at screening. Assessment may be repeated once during Screening if FeNO > 20 ppb, and highest value during Screening period is considered for eligibility. 4. A screening pre-bronchodilator FEV1 >=60% of predicted normal value 5. Asthma Control Test (ACT) score >19 6. Maintained control on as-needed short-acting beta-agonist (SABA) +/- stable dose of inhaled corticosteroids (ICS) or stable dose of ICS/LABA (long-acting beta-agonist), within permitted ICS dose as specified below; +/- stable dose of leukotriene receptor antagonist (LTRA). ICS dose should be stable for >=12 weeks prior to Day 1 and maintained during the course of the study, LTRA dose should be stable for >=8 weeks prior to Day 1 and maintained during the course of the study 7. Otherwise healthy other than asthma as defined above; patients with other mild, well controlled atopic diseases including allergic rhinitis and AD are permitted, provided no systemic therapies or intranasal or ocular corticosteroids are being used during screening or during the course of the study, and other inclusion/exclusion criteria are met 8. Willing to use a highly effective method of contraception from admission through 30 days after EOS or 5 half-lives after the last administration of study drug, whichever is longer 9. Willing to abstain from regular, continuous alcohol use (defined as an average of >10 standard drinks per week or at the Investigator's discretion) or tobacco use (defined as >=5 cigarettes per day or equivalent) for 48 hours prior to admission to the CRU (Day -1) and any illicit drugs of abuse for >=48 hours prior to admission to the CRU (Day -1) Note: Other protocol-defined inclusion criteria may apply.
Exclusion criteria
For SAD cohorts- 1. Evidence of clinically significant abnormalities or disease 2. Known history of illicit drug abuse, harmful alcohol use (defined as an average of >10 standard drinks per week or at the Investigator’s discretion) or alcoholism, and/or excessive tobacco use (defined as >=5 cigarettes per day or equivalent) within 2 years prior to Screening (or at the Investigator’s discretion); positive screen for drugs of abuse (except tetrahydrocannabinol), or positive cotinine or alcohol breath test at Screening or admission to the CRU (or at the Investigator’s discretion), and participants must abstain from cigarette smoking for the duration of their stay in the CRU; participants may be rescreened for drugs of abuse or alcohol breath test at the Investigator’s discretion 3. History of severe allergic reactions or hypersensitivity (i.e., anaphylaxis) 4. If female, nursing, lactating, pregnant, or plans to become pregnant within 30 days of EOS or 5 half-lives (whichever is longer) of last study drug administration 5. Use of any investigational drug therapy within 30 days or 5 half-lives (whichever is longer) prior to study drug dosing through 5 half-lives after the last dose of study drug For MD cohort- 1. Any asthma exacerbation requiring systemic corticosteroids within 12 weeks of screening; any asthma exacerbation that resulted in overnight hospitalization within 6 months prior to screening 2. Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia 3. History of biologics use for treatment or control of asthma 4. Any concomitant respiratory disease that in the opinion of the Investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of patient safety or study results 5. Respiratory Infection 6. Evidence of clinically significant abnormalities or disease other than as previously described 7. Current smokers or patients with a smoking history of >=10 pack years (number of pack years = number of cigarettes per day/20*number of years smoked). Former smokers with <10 pack years must have stopped for at least 12 months to be eligible for screening 8. Known history of illicit drug abuse, harmful alcohol use (defined as an average of >10 standard drinks per week or at the Investigator’s discretion) or alcoholism; positive screen for drugs of abuse (except tetrahydrocannabinol), or positive cotinine or alcohol breath test at Screening or admission to the CRU (or at the Investigator’s discretion). Patients may be rescreened for drugs of abuse or alcohol breath test at the Investigator’s discretion 9. History of severe allergic reactions or hypersensitivity (ie, anaphylaxis) 10. If female: nursing, lactating, pregnant, or plans to become pregnant within 30 days of EOS or 5 half-lives (whichever is longer) of last study drug administration 11. Use of any investigational drug therapy within 30 days or 5 half-lives (whichever is longer) prior to study drug dosing through 5 half-lives after the last dose of study drug Note: Other protocol-defined exclusion criteria may apply.
Outcome results
None listed