NCT06625541
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- AJ302-IM
- Conditions
- Healthy Volunteers
- Sponsor
- AnnJi Pharmaceutical Co., Ltd.
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Incidence and proportion of volunteers with AEs including TEAEs and SAEs
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
AJ302-IM
Intervention: AJ302-IM
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence and proportion of volunteers with AEs including TEAEs and SAEs
Time Frame: Baseline up to Day 57
Secondary Outcomes
- Plasma PK of AJ302-IM(Pre-dose to Day 57)
- Urine PK of AJ302-IM(Pre-dose to Day 8)
Study Sites (1)
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