A Phase 1, Randomized, Blinded, Placebo-controlled, Single Ascending Dose, First-in-human, Study of the Safety, Tolerability, and Pharmacokinetics of APG808 in Healthy Participants

Apogee Therapeutics, Inc.0 sites32 target enrollmentMarch 11, 2024

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Apogee Therapeutics, Inc.
Enrollment: 32
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 11, 2024

End Date

TBD

Last Updated

2 years ago

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 to 35 kg/m^2 (kilogram per square meter) (inclusive), weight \<120 kg
•3\. Willing and able to speak, read, and understand English, and provide written informed consent after the nature of the study has been explained and prior to the start of any study procedures
•4\. Willing and able to attend the necessary visits to the CRU, and comply with all testing and requirements defined in the protocol
•5\. Willing and able to remain at the study site unit for the duration of the confinement period and return for the outpatient visit(s) defined in the protocol
•6\. 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
•7\. 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\)
•8\. Non\-tattooed, clear injection site (i.e., absence of dermatologic conditions, such as scarring or rash, that may impact the ability to assess injection site reactions) suitable for SC injection and monitoring in the opinion of the Investigator
•9\. Agrees to comply with the drawing of blood samples for the PK and PD assessments

Exclusion Criteria

•1\. Evidence of clinically significant abnormalities or disease
•a. Diagnosis of diabetes mellitus
•b. Positive test for human immunodeficiency virus antibody
•c. Acute or chronic hepatitis B or C as evidenced by hepatitis B surface antigen and/or hepatitis C antibody; evidence of resolved infection or status post\-vaccination with the presence of antibodies or documented absence of viral deoxyribonucleic acid on polymerase chain reaction is allowed
•d. Diagnosis or suspected diagnosis of immunodeficiency or autoimmune diseases, or undergoing immunosuppressive therapy such as anticancer chemotherapy or radiotherapy before the trial, or has received systemic corticosteroid treatment (topical corticosteroids are acceptable) within the past 120 days before dosing
•e. Significant history or clinical manifestation of any metabolic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory,
•endocrine, or psychiatric disorder, acute or chronic infectious diseases and malignancies, as determined by the Investigator
•f. History or presence of conditions which, in the judgment of the Investigator, are known to
•interfere with the absorption, distribution, metabolism, or excretion of drugs
•g. Liver function tests (i.e., alanine aminotransferase, aspartate aminotransferase) \>1\.5 times the upper limit of normal; elevated bilirubin is not allowed unless due to Gilbert's syndrome