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NCT05517603 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Of AJ201 In Patients

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

Completed
Registry status
Phase 1
Development phase
25
Enrollment target

NCT05517603: Completed Phase 1 study, sponsored by AnnJi Pharmaceutical Co..

NCT05517603 is a Phase 1 study that has completed, run by AnnJi Pharmaceutical Co.. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05517603, a Phase 1 study, has completed, sponsored by AnnJi Pharmaceutical Co..

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target

Study Summary

This is a phase 1/2a randomized, double-blind study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of study drug AJ201 in subjects with Spinal and Bulbar Muscular Atrophy (SBMA).

Primary Outcome

Safety will be monitored throughout the study.

Interventions

  • DRUG Placebo
  • DRUG AJ201

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2023-02-28
Est. Completion 2024-04-08
Phase Phase 1
AnnJi Pharmaceutical Co.

3 total trials

What the finished NCT05517603 record still lists

NCT05517603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05517603 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05517603 about?

NCT05517603 is a clinical study titled "A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Of AJ201 In Patients". This is a phase 1/2a randomized, double-blind study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of study drug AJ201 in subjects with Spinal and Bulbar Muscular Atrophy (SBMA).

What is the current status of trial NCT05517603?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2023-02-28. Estimated completion is 2024-04-08.

What interventions are being tested in trial NCT05517603?

The interventions under investigation include: Placebo (DRUG), AJ201 (DRUG).

Who is sponsoring clinical trial NCT05517603?

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 NCT05517603's enrollment target sits among peer trials

25 1495th of 2000 higher than 481 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 NCT05517603, the US trial registry maintained by the National Library of Medicine. NCT05517603 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.