None listed
Conditions
Brief summary
The main aim of the study is to test the safety, tolerability, pharmacokinetics, and immunogenicity of a single dose of APG333. The results of this study will help inform the dosing and frequency of dosing in patients with inflammatory diseases such as asthma and chronic obstructive pulmonary disease, which is the anticipated main therapeutic use for APG333.
Interventions
This study will evaluate single ascending doses (SAD) of APG333 administered subcutaneously (SC) in healthy participants. In each of 4 treatment cohorts (maximum), 8 participants will be randomized 6:2 to APG333 or placebo (up to 32 participants total).
Cohort 1 - APG333 Dose 125 milligram (mg) or placebo
Cohort 2 - APG333 Dose 250 mg or placebo
Cohort 3 - APG333 Dose 500 mg or placebo
Cohort 4 - APG333 Dose 1000 mg or placebo
The study will be conducted in Australia. The anticipated duration
This study will evaluate single ascending doses (SAD) of APG333 administered subcutaneously (SC) in healthy participants. In each of 4 treatment cohorts (maximum), 8 participants will be randomized 6:2 to APG333 or placebo (up to 32 participants total). Cohort 1 - APG333 Dose 125 milligram (mg) or placebo Cohort 2 - APG333 Dose 250 mg or placebo Cohort 3 - APG333 Dose 500 mg or placebo Cohort 4 - APG333 Dose 1000 mg or placebo The study will be conducted in Australia. The anticipated duration of the study is up to approximately 267 days, including screening and safety follow-up.
Sponsors
Apogee Therapeutics, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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 18.0 to 32.0 kilogram per square meter (kg/m^2) (inclusive), weight less than (<) 120 kilogram (kg) 3. Willing to use a highly effective method of contraception through 30 days after end of study (EOS) or 5 half-lives after the last administration of study drug, whichever is longer 4. Willing to abstain from alcohol, tobacco, and illicit drug use for 48 hours prior to admission to the CRU (Day -1) and during the inpatient period.
Exclusion criteria
1. Evidence of clinically significant abnormalities or disease. History of any of the following: a. Clinically significant opportunistic infection (eg, invasive candidiasis or pneumocystis pneumonia) within 5 years prior to Screening b. Serious local infection (eg, cellulitis) or system infection (eg, septicemia) within 3 months prior to Screening 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 or e-cigarette equivalent [0.5 mL e cigarette fluid equivalent to 5 cigarettes] per day) within 2 years prior to Screening; positive screen for drugs of abuse (except tetrahydrocannabinol [THC]), or positive alcohol breath test at Screening or admission to the CRU (or at the Investigator’s discretion), and participants must abstain from cigarette smoking and vaping 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 (ie, 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 study drug administration 5. Use of any prescription or nonprescription medication 7 days prior to dosing through CRU discharge Day 4 (exception: contraceptives, hormone replacement therapy, vitamins, over-the-counter [OTC] antihistamines, OTC topical steroids, or acetaminophen/paracetamol up to 2 gram (g) per day prior to dosing is permitted) 6. 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
Outcome results
None listed