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NCT05508204 · ClinicalTrials.gov registry record · Phase 1

Open-label Safety and PK Study of BION-1301 in Japanese Healthy Subjects

A Phase 1 study, sponsored by Chinook Therapeutics.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target

NCT05508204: Completed Phase 1 study, sponsored by Chinook Therapeutics.

NCT05508204 is a Phase 1 study that has completed, run by Chinook Therapeutics. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05508204, a Phase 1 study, has completed, sponsored by Chinook Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target

Study Summary

Phase 1, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of multiple doses of BION-1301 in Japanese healthy subjects.

Primary Outcome

Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs); changes from baseline in safety parameters; and number of subjects with injection site reactions

Interventions

  • DRUG BION-1301

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2022-07-19
Est. Completion 2022-12-16
Phase Phase 1
Chinook Therapeutics

4 total trials

What the finished NCT05508204 record still lists

NCT05508204 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 1 intervention - of which BION-1301 is the first listed.

NCT05508204 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05508204 about?

NCT05508204 is a clinical study titled "Open-label Safety and PK Study of BION-1301 in Japanese Healthy Subjects". Phase 1, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of multiple doses of BION-1301 in Japanese healthy subjects.

What is the current status of trial NCT05508204?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2022-07-19. Estimated completion is 2022-12-16.

What interventions are being tested in trial NCT05508204?

The interventions under investigation include: BION-1301 (DRUG).

Who is sponsoring clinical trial NCT05508204?

This trial is sponsored by Chinook Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05508204's enrollment target sits among peer trials

36 1210th of 2000 higher than 743 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 NCT05508204, the US trial registry maintained by the National Library of Medicine. NCT05508204 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.