A Phase 1, Randomized, Single-dose, Open-label, Two-way, Crossover Study to Evaluate the Effect of Food on AJ201, and to Evaluate the Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants
AnnJi Pharmaceutical Co., Ltd.
Summary
This is a Phase 1, randomized, single-dose, open-label, two-way crossover study to evaluate the effect of food on AJ201, and to evaluate the safety, tolerability, and pharmacokinetics of AJ201 in Japanese and White healthy male participants.
Eligibility
- Age range
- 18–55 years
- Sex
- Male
- Healthy volunteers
- Yes
Key Inclusion Criteria: * Male, non-smokers (no use of tobacco or nicotine products within 3 months prior to Screening), ≥ 18 and ≤ 55 years of age, with body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 and body weight ≥ 50.0 kg. * 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 a clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, depression, attempted suicide, gastrointest…
Interventions
- DrugAJ201
All participants are planned to be administered a single dose of AJ201 for each period (fed and fasted).
Location
- AnnJi Investigational SiteLos Alamitos, California