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NCT06395285 · ClinicalTrials.gov registry record · Phase 1

Evaluating the Safety and Tolerability of Orally Administered DF-003 in ROSAH Syndrome Patients

A Phase 1 study of ROSAH, sponsored by Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm).

Recruiting
Registry status
Phase 1
Development phase
12
Enrollment target
4
Study locations

NCT06395285: Recruiting Phase 1 study of ROSAH, sponsored by Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm).

NCT06395285 is a Phase 1 study of ROSAH that is actively recruiting participants, run by Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm). The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06395285, a Phase 1 study of ROSAH, is actively recruiting participants, sponsored by Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm).

RECRUITING
Registry status
Phase 1
Development phase
12 participants
Enrollment target
4
Study locations

Study Summary

The purpose of this study is to evaluate the safety and tolerability of DF-003 in retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis, and migraine headache (ROSAH) syndrome patients.

Conditions Studied

Interventions

  • DRUG DF-003

Study Locations (4)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

North Carolina

  • Duke Eye Center - Duke University Hospital - Durham

Utah

  • John A. Moran Eye Center - University of Utah Health - Salt Lake City

New South Wales

  • Save Sight Institute - University of Sydney Eye Hospital - Sydney

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2025-05-27
Est. Completion 2026-05
Phase Phase 1

What NCT06395285 shows while recruiting

NCT06395285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 1 condition, with ROSAH appearing as the primary indexed condition, and to 1 intervention - of which DF-003 is the first listed.

NCT06395285 reports a single indexed study location in Maryland, North Carolina, Utah.

Frequently Asked Questions

What is clinical trial NCT06395285 about?

NCT06395285 is a clinical study titled "Evaluating the Safety and Tolerability of Orally Administered DF-003 in ROSAH Syndrome Patients". The purpose of this study is to evaluate the safety and tolerability of DF-003 in retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis, and migraine headache (ROSAH) syndrome patients.

What is the current status of trial NCT06395285?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-05-27. Estimated completion is 2026-05.

What conditions does trial NCT06395285 study?

This clinical trial studies the following conditions: ROSAH.

What interventions are being tested in trial NCT06395285?

The interventions under investigation include: DF-003 (DRUG).

Who is sponsoring clinical trial NCT06395285?

This trial is sponsored by Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm), which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06395285 being conducted?

This trial has 4 study locations across Maryland, North Carolina, Utah, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for ROSAH

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06395285's enrollment target sits among peer trials

12 1853rd of 2000 higher than 90 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 NCT06395285, the US trial registry maintained by the National Library of Medicine. NCT06395285 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.