A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJ302-IM in Healthy Volunteers

AnnJi Pharmaceutical

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo

Drug: AJ302-IM

Study type

Interventional

Funder types

Industry

Identifiers

NCT06625541

AJ79009-302IM-101

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AJ302-IM following intramuscular administration of single ascending doses in healthy volunteers.

Enrollment

57 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Male or female, non-smokers (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 55years of age, with body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
Normal renal function at screening.
Healthy as defined by:
- The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
- The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, depression, attempted suicide, gastrointestinal, renal, hepatic, and metabolic disease.
Able to understand the study procedures and provide signed informed consent to participate in the study

Key Exclusion Criteria:

Any clinically significant abnormal finding at physical examination
Any lifetime suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) in the 2 years before screening based on the C-SSRS
Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, at screening
Positive pregnancy test or lactating female volunteers
Positive urine drug screen, urine cotinine test, or alcohol breath test at screening and on Day -1
History of significant allergic reactions to any drug
Known allergy or hypersensitivity to histone deacetylase 6 (HDAC6) inhibitors or its derivatives and/or any study product excipients
Clinically significant ECG abnormalities or vital signs abnormalities at screening
History of drug abuse or recreational use of soft drugs or hard drugs
History of alcohol abuse
History of smoking or uses other nicotine-containing products
Undergone major surgery ≤ 2 months before study drug administration
History of clinically significant opportunistic infection or serious local infection or significant medical/surgical procedure or trauma, or any current infection.
Use of medications for the timeframes specified in the protocol
Received any investigational drug or any investigational device or any biological product within the timeframes specified in the protocol
Tattoos, sunburn, scarring or anything that may interfere with evaluation of the injection site