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

Conditions

• Food Effect in Healthy Volunteers
• Healthy Male Adults

Eligibility Criteria

Sex

MALE

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• AJ201 — DRUG
  All participants are planned to be administered a single dose of AJ201 for each period (fed and fasted).

Study Details

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.

Key Dates

Start date

Apr 9, 2026

Status verified

Apr 2026

Primary completion

Apr 22, 2026

Completion

Apr 27, 2026

Study Design

Enrollment

26 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (Japanese)
  Japanese Participants
• Experimental: Arm B (White)
  White Participants

Primary Outcome Measure

Plasma PK of AJ201 [ Time Frame: Pre-dose to Day 6 ]

Central Contacts

• Andy Chen, PhD
  +886223655677
  [email protected]

Locations (1)

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