Clinical trial NCT06625541: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJ302-IM 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: AnnJi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-03
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence and proportion of volunteers with AEs including TEAEs and SAEs
timeFrame: Baseline up to Day 57
Secondary outcomes:
measure: Plasma PK of AJ302-IM
timeFrame: Pre-dose to Day 57
measure: Plasma PK of AJ302-IM
timeFrame: Pre-dose to Day 57
measure: Plasma PK of AJ302-IM
timeFrame: Pre-dose to Day 57
measure: Plasma PK of AJ302-IM
timeFrame: Pre-dose to Day 57
measure: Plasma PK of AJ302-IM
timeFrame: Pre-dose to Day 57
measure: Plasma PK of AJ302-IM
timeFrame: Pre-dose to Day 57
measure: Plasma PK of AJ302-IM
timeFrame: Pre-dose to Day 57
measure: Plasma PK of AJ302-IM
timeFrame: Pre-dose to Day 57
measure: Plasma PK of AJ302-IM
timeFrame: Pre-dose to Day 57
measure: Plasma PK of AJ302-IM
timeFrame: Pre-dose to Day 57
measure: Urine PK of AJ302-IM
timeFrame: Pre-dose to Day 8
measure: Urine PK of AJ302-IM
timeFrame: Pre-dose to Day 8
measure: Urine PK of AJ302-IM
timeFrame: Pre-dose to Day 8
measure: Urine PK of AJ302-IM
timeFrame: Pre-dose to Day 8
Other outcomes:
Locations:
city: Miami
country: United States
facility: AnnJi Investigational Site
state: Florida
Study officials:
References: