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

NCT ID: NCT06625541

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-24

Study Completion Date

2025-08-15

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AJ302-IM

Group Type EXPERIMENTAL

AJ302-IM

Intervention Type DRUG

7 cohorts (7 dose levels) of participants are planned to be dosed.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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AJ302-IM

7 cohorts (7 dose levels) of participants are planned to be dosed.

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AnnJi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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AnnJi Investigational Site

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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AJ79009-302IM-101

Identifier Type: -

Identifier Source: org_study_id