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

Last updated: October 1, 2024
Sponsor: AnnJi Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

Placebo

AJ302-IM

Clinical Study ID

NCT06625541
AJ79009-302IM-101
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Male or female, non-smokers (no use of tobacco or nicotine products within 3 monthsprior to screening), ≥ 18 and ≤ 55years of age, with body mass index (BMI) ≥ 18.5and ≤ 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 priorto study drug administration.

  • The absence of clinically significant history of neurological, endocrine,cardiovascular, respiratory, hematological, immunological, psychiatric,depression, attempted suicide, gastrointestinal, renal, hepatic, and metabolicdisease.

  • Able to understand the study procedures and provide signed informed consent toparticipate in the study

Exclusion

Key Exclusion Criteria:

  • Any clinically significant abnormal finding at physical examination

  • Any lifetime suicidal behavior or suicidal ideation of type 4 (active suicidalideation with some intent to act, without specific plan) or type 5 (active suicidalideation with specific plan and intent) in the 2 years before screening based on theC-SSRS

  • Clinically significant abnormal laboratory test results or positive serology testresults 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 screeningand on Day -1

  • History of significant allergic reactions to any drug

  • Known allergy or hypersensitivity to histone deacetylase 6 (HDAC6) inhibitors or itsderivatives 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 infectionor 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 biologicalproduct within the timeframes specified in the protocol

  • Tattoos, sunburn, scarring or anything that may interfere with evaluation of theinjection site

Study Design

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
June 24, 2024
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • AnnJi Investigational Site

    Miami, Florida 33136
    United States

    Active - Recruiting

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