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NCT05337878 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pelacarsen (ISIS 681257) in Healthy Japanese Participants

A Phase 1 study, sponsored by Ionis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
29
Enrollment target

NCT05337878: Completed Phase 1 study, sponsored by Ionis Pharmaceuticals.

NCT05337878 is a Phase 1 study that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05337878, a Phase 1 study, has completed, sponsored by Ionis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
29 participants
Enrollment target

Study Summary

The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple subcutaneous (SC) doses of Pelacarsen (ISIS 681257) in healthy Japanese participants.

Interventions

  • DRUG Placebo
  • DRUG Pelacarsen

Trial Details

FieldValue
Enrollment Target 29 participants
Start Date 2018-10-15
Est. Completion 2019-12-18
Phase Phase 1
Ionis Pharmaceuticals

76 total trials

What the finished NCT05337878 record still lists

NCT05337878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).

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

NCT05337878 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05337878 about?

NCT05337878 is a clinical study titled "A Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pelacarsen (ISIS 681257) in Healthy Japanese Participants". The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple subcutaneous (SC) doses of Pelacarsen (ISIS 681257) in healthy Japanese participants.

What is the current status of trial NCT05337878?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2018-10-15. Estimated completion is 2019-12-18.

What interventions are being tested in trial NCT05337878?

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

Who is sponsoring clinical trial NCT05337878?

This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05337878's enrollment target sits among peer trials

29 1440th of 2000 higher than 554 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 NCT05337878, the US trial registry maintained by the National Library of Medicine. NCT05337878 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.