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

NCT06625541 | Completed Phase 1 FDA Drug

• 1 other identifier: AJ79009-302IM-101
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence and proportion of volunteers with AEs including TEAEs and SAEs

  Baseline up to Day 57

Secondary Outcomes (14)

• Plasma PK of AJ302-IM

  Pre-dose to Day 57

• Plasma PK of AJ302-IM

  Pre-dose to Day 57

• Plasma PK of AJ302-IM

  Pre-dose to Day 57

• Plasma PK of AJ302-IM

  Pre-dose to Day 57

• Plasma PK of AJ302-IM

  Pre-dose to Day 57

Study Arms (2)

AJ302-IM

EXPERIMENTAL

Drug: AJ302-IM

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

AJ302-IM DRUG

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

AJ302-IM

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AnnJi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

AnnJi Investigational Site

Miami, Florida, 33136, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: October 3, 2024
• Study Start: June 24, 2024
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)