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NCT03836859 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Safety, Tolerability & PK of rhNGF in Healthy Volunteers
A Phase 1 study, sponsored by Dompé Farmaceutici S.p.A.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03836859: Completed Phase 1 study, sponsored by Dompé Farmaceutici S.p.A.
NCT03836859 is a Phase 1 study that has completed, run by Dompé Farmaceutici S.p.A. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03836859, a Phase 1 study, has completed, sponsored by Dompé Farmaceutici S.p.A.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the safety and tolerability of a single short-term and a multiple dose scheme of rhNGF when administered as eye drops in healthy subjects of Japanese ethnicity. The secondary objective of this study is to assess the pharmacokinetics of single and multiple doses of rhNGF when administered as eye drops in healthy subjects of Japanese ethnicity.
Primary Outcome
TEAEs were defined as an adverse event (AE), which started after the first dose of study treatment. These comprise AEs during the treatment and follow-up period. For TEAE the number of events was provided.
Interventions
- OTHER Placebo
- DRUG rhNGF 20μg/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-03-30 |
| Est. Completion | 2018-06-01 |
| Phase | Phase 1 |
What the finished NCT03836859 record still lists
NCT03836859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03836859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03836859 about?
NCT03836859 is a clinical study titled "Study to Evaluate Safety, Tolerability & PK of rhNGF in Healthy Volunteers". The primary objective of this study is to assess the safety and tolerability of a single short-term and a multiple dose scheme of rhNGF when administered as eye drops in healthy subjects of Japanese ethnicity. The secondary objective of this study is to assess the pharmacokinetics of single and mul...
What is the current status of trial NCT03836859?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2018-03-30. Estimated completion is 2018-06-01.
What interventions are being tested in trial NCT03836859?
The interventions under investigation include: Placebo (OTHER), rhNGF 20μg/mL (DRUG).
Who is sponsoring clinical trial NCT03836859?
This trial is sponsored by Dompé Farmaceutici S.p.A, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03836859's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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