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NCT06659263 · ClinicalTrials.gov registry record · Phase 1

RE104 Clinical Lactation Study

A Phase 1 study, sponsored by Reunion Neuroscience.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target

NCT06659263: Completed Phase 1 study, sponsored by Reunion Neuroscience.

NCT06659263 is a Phase 1 study that has completed, run by Reunion Neuroscience. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06659263, a Phase 1 study, has completed, sponsored by Reunion Neuroscience.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

Study Summary

The purpose of this study is to obtain data necessary to characterize the elimination of RE104 and metabolites from breastmilk of health lactating volunteers to support a regulatory assessment of when mothers can safely return to breastfeeding following a single-dose of RE104 for Injection.

Interventions

  • DRUG RE104 for Injection

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2024-11-13
Est. Completion 2025-06-04
Phase Phase 1
Reunion Neuroscience

5 total trials

What the finished NCT06659263 record still lists

NCT06659263 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 1 intervention - of which RE104 for Injection is the first listed.

NCT06659263 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06659263 about?

NCT06659263 is a clinical study titled "RE104 Clinical Lactation Study". The purpose of this study is to obtain data necessary to characterize the elimination of RE104 and metabolites from breastmilk of health lactating volunteers to support a regulatory assessment of when mothers can safely return to breastfeeding following a single-dose of RE104 for Injection.

What is the current status of trial NCT06659263?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2024-11-13. Estimated completion is 2025-06-04.

What interventions are being tested in trial NCT06659263?

The interventions under investigation include: RE104 for Injection (DRUG).

Who is sponsoring clinical trial NCT06659263?

This trial is sponsored by Reunion Neuroscience, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06659263's enrollment target sits among peer trials

14 1844th of 2000 higher than 154 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 NCT06659263, the US trial registry maintained by the National Library of Medicine. NCT06659263 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.