A Phase 1, Randomized, Blinded, Placebo-controlled, Single Ascending Dose, First-in-human Study of the Safety, Tolerability, and Pharmacokinetics of APG990 in Healthy Participants

Apogee Therapeutics, Inc.0 sites40 target enrollmentJune 25, 2024

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Apogee Therapeutics, Inc.
Enrollment: 40
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 25, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Apogee Therapeutics, Inc.

Eligibility Criteria

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