COMPLETED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of AJ302-IM in Healthy Volunteers Via Intramuscular Injection

Quick Facts

Study Start:2024-06-24

Study Completion:2025-08-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06625541

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Locations (Sites)

AnnJi Investigational Site

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: AnnJi Pharmaceutical Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-24

Study Completion Date2025-08-15

Study Record Updates

Study Start Date2024-06-24

Study Completion Date2025-08-15

Terms related to this study

Additional Relevant MeSH Terms

Healthy Volunteers