None listed
Conditions
Brief summary
The main aim of the study is to evaluate the safety and tolerability of single doses of APG990 in healthy participants. The results of this study will help inform the dosing and frequency of dosing in patients with inflammatory diseases such as atopic dermatitis, which is the anticipated main therapeutic use for APG990.
Interventions
This study will evaluate single ascending doses (SAD) of APG990 administered subcutaneously (SC) in healthy participants. In each of 5 treatment cohorts (maximum), 8 participants will be randomized 6:2 to APG990 or placebo (up to 40 participants total).
Cohort 1 - APG990 Dose 75 milligram (mg) or placebo
Cohort 2 - APG990 Dose 150 mg or placebo
Cohort 3 - APG990 Dose 300 mg or placebo
Cohort 4 - APG990 Dose 600 mg or placebo
Cohort 5 - APG990 Dose 1200 mg or placebo
The study will be conducte
This study will evaluate single ascending doses (SAD) of APG990 administered subcutaneously (SC) in healthy participants. In each of 5 treatment cohorts (maximum), 8 participants will be randomized 6:2 to APG990 or placebo (up to 40 participants total). Cohort 1 - APG990 Dose 75 milligram (mg) or placebo Cohort 2 - APG990 Dose 150 mg or placebo Cohort 3 - APG990 Dose 300 mg or placebo Cohort 4 - APG990 Dose 600 mg or placebo Cohort 5 - APG990 Dose 1200 mg or placebo The study will be conducted at a single site in Australia. The anticipated duration of the study is up to approximately 267 days, including screening and safety follow-up. This is a single dose study. The study drug will be administered in the clinical research unit (CRU) by qualified/trained study staff. Any issues or deviations that occur during dosing will be reported to the Sponsor as soon as feasibly possible.
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 (inclusive) 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 from 30 days prior to admission 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 and tobacco use for 48 hours prior to admission to the CRU (Day -1) and during inpatient period, and any illicit drug abuse for greater than or equal to (>=) 48 hours prior to admission to the CRU (Day -1)
Exclusion criteria
1. Evidence of clinically significant abnormalities or disease 2. 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 systemic infection (eg, septicemia) within 3 months prior to Screening 3. 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 heavy tobacco use (defined as >=5 cigarettes per day or equivalent) within 2 years prior to Screening; positive screen for drugs of abuse (except tetrahydrocannabinol [THC]), 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 4. History of severe allergic reactions or hypersensitivity (ie, anaphylaxis) 5. 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 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 7. Use of any depot injection or implant for 3 months prior to dosing
Outcome results
None listed