A Study to Evaluate the Effect of Food on the Bioavailability of AJ201, and Safety, Tolerability, and Pharmacokinetics of AJ201 in Japanese and White Healthy Male Participants

Recruiting Phase 1 Interventional Study
Healthy Male Adults Food Effect in Healthy Volunteers
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 55
Sex
Male
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
26 (estimated)
Sponsor
AnnJi Pharmaceutical Co., Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 …
Contacts

Andy Chen, PhD

+886223655677

andy.chen@ajpharm.com

CONTACT