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NCT07549919 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by AnnJi Pharmaceutical Co..

Recruiting
Registry status
Phase 1
Development phase
26
Enrollment target

NCT07549919: Recruiting Phase 1 study, sponsored by AnnJi Pharmaceutical Co..

NCT07549919 is a Phase 1 study that is actively recruiting participants, run by AnnJi Pharmaceutical Co.. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07549919, a Phase 1 study, is actively recruiting participants, sponsored by AnnJi Pharmaceutical Co..

RECRUITING
Registry status
Phase 1
Development phase
26 participants
Enrollment target

Study 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.

Primary Outcome

AUC0-24hr: Area under the concentration-time curve from zero to 24 hours under fasting and fed conditions

Interventions

  • DRUG AJ201

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2026-04-09
Est. Completion 2026-04-27
Phase Phase 1
AnnJi Pharmaceutical Co.

3 total trials

What NCT07549919 shows while recruiting

NCT07549919 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 1 intervention - of which AJ201 is the first listed.

NCT07549919 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07549919 about?

NCT07549919 is a clinical study titled "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". 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.

What is the current status of trial NCT07549919?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2026-04-09. Estimated completion is 2026-04-27.

What interventions are being tested in trial NCT07549919?

The interventions under investigation include: AJ201 (DRUG).

Who is sponsoring clinical trial NCT07549919?

This trial is sponsored by AnnJi Pharmaceutical Co., which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07549919's enrollment target sits among peer trials

26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07549919, the US trial registry maintained by the National Library of Medicine. NCT07549919 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.