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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: AJ302-IM

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • AnnJi Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo
Experimental: AJ302-IM	Drug: AJ302-IM; 7 cohorts (7 dose levels) of participants are planned to be dosed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and proportion of volunteers with AEs including TEAEs and SAEs	Baseline up to Day 57

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma PK of AJ302-IM	AUC0-168hr: Area under the plasma concentration-time curve from zero to 168 hours	Pre-dose to Day 57
Plasma PK of AJ302-IM	AUC0-inf: Area under the concentration-time curve from time zero to infinity (extrapolated)	Pre-dose to Day 57
Plasma PK of AJ302-IM	AUC0-last: Area under the plasma concentration-time curve from zero to the last observed concentrations	Pre-dose to Day 57
Plasma PK of AJ302-IM	Cmax: Maximal observed concentration	Pre-dose to Day 57
Plasma PK of AJ302-IM	Tmax: Time when the maximal concentration is observed	Pre-dose to Day 57
Plasma PK of AJ302-IM	Residual area: Percentage of AUC0-inf due to extrapolation from the time of the last observed concentration to infinity, calculated as [1 (AUC0 last/AUC0-inf)] x 100	Pre-dose to Day 57
Plasma PK of AJ302-IM	T½ el: Terminal elimination half-life	Pre-dose to Day 57
Plasma PK of AJ302-IM	Kel: Terminal elimination rate constant	Pre-dose to Day 57
Plasma PK of AJ302-IM	Cl/F: Apparent clearance	Pre-dose to Day 57
Plasma PK of AJ302-IM	Vz/F: Apparent volume of distribution	Pre-dose to Day 57
Urine PK of AJ302-IM	Ae0-168hr: Cumulative urinary excretion from time zero to 168 hours, calculated as the sum of the amounts excreted over each collection interval	Pre-dose to Day 8
Urine PK of AJ302-IM	Rmax: Maximal rate of urinary excretion, calculated by dividing the amount of drug excreted in each collection interval by the time over which it was collected	Pre-dose to Day 8
Urine PK of AJ302-IM	TRmax: Time of maximal urinary excretion, calculated as the midpoint of the collection interval during which Rmax occurred	Pre-dose to Day 8
Urine PK of AJ302-IM	ClR: Renal clearance, calculated as Ae0-168hr /AUC0-168hr	Pre-dose to Day 8

Collaborators and Investigators

• Sponsor: AnnJi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Actual): August 15, 2025
• Study Completion (Actual): August 15, 2025

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: October 1, 2024
• First Posted (Actual): October 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: AJ79009-302IM-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No