Trial · NCT03836859
Study to Evaluate Safety, Tolerability & PK of rhNGF in Healthy Volunteers
NCT03836859, Phase 1, Completed, Dompé Farmaceutici S.p.A; results first posted 2020-06-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Safety, Tolerability & PK of rhNGF in Healthy Volunteers. Trials, record NCT03836859. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03836859
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Safety, Tolerability & PK of rhNGF in Healthy Volunteers
- NCT number
- NCT03836859
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 30 participants, actual
- Lead sponsor
- Dompé Farmaceutici S.p.A
- Conditions
- Healthy Volunteers
- Interventions
- rhNGF 20μg/mL, Placebo
- First posted
- 2019-02-11
- Last updated
- 2023-12-26
- Results first posted
- 2020-06-11
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment Emergent Adverse Events (TEAEs). | On Day 1 (single dose scheme), Days 2-6 (multiple dose scheme), Day 7 (Follow-up [FU] 1), Day 8 (FU 2); Day 16 (FU 3), and Day 35-42 (FU 4) | 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. |
| Primary | Number of Treatment Emergent Adverse Events During First Dose Schedule (TEAEs Dose 1). | During first dose schedule (TEAE Dose 1, which started after first dose of study treatment at Day 1 till before administration of the first dose at Treatment Day 2) | TEAEs Dose 1 were defined as TEAEs, which started after the first dose of study treatment and before administration of the first dose at Treatment Day 2. For TEAE the number of events was provided. |
| Primary | Number of Treatment Emergent Adverse Events During Second Dose Schedule (TEAEs Dose 2). | During second dose schedule (TEAE Dose 2, which started on/after the first dose at Treatment Day 2 till before Follow-Up Day 7 (FU1) visit | TEAEs Dose 2 were defined as TEAEs, which started on/after the first dose at Treatment Day 2 and before Follow-Up Day 7 visit. |
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Ocular Tolerability Score in Study Eye: Single Dose | at Treatment Day 2 pre-dose | Change from baseline in VAS ocular tolerability score in study eye at Treatment Day 2 predose (Tolerability of 1x0.70 μg rhNGF per day) for overall is presented. In this context, "Baseline" was defined as the pre-treatment assessment at the Baseline (D-1) visit. A ocular tolerability score was determined using a 100 mm VAS on which 0 meant No symptoms and 100 meant the Worst possible discomfort. The patients subjectively evaluated their ocular symptoms (foreign body sensation, burning or stinging, itching, pain, sticky feeling, blurred vision and photophobia) using the VAS giving the value they were feeling from none to an extreme value. The ocular symptoms were evaluated by the patients through the scale. |
| Primary | Change From Baseline in Visual Analogue Scale (VAS) Ocular Tolerability Score in Study Eye: Multiple Dose | at Day 2 8h, Day 3 predose, Day 6 pre-dose, Day 6 8h, Day 7 (FU1), Day 8 (FU2), Day 16 (FU3) | Change from baseline in VAS ocular tolerability score in study eye at Day 2 8h, Day 3 predose, Day 6 pre-dose, Day 6 8h, Day 7 (FU1), Day 8 (FU2), Day 16 (FU3) (Tolerability of 6x0.70 μg rhNGF per day) for overall is presented. In this context, "Baseline" was defined as the pre-treatment assessment at the Baseline (D-1) visit.A ocular tolerability score was determined using a 100 mm VAS on which 0 meant No symptoms and 100 meant the Worst possible discomfort. The patients subjectively evaluated their ocular symptoms (foreign body sensation, burning or stinging, itching, pain, sticky feeling, blurred vision and photophobia) using the VAS giving the value they were feeling from none to an extreme value. The ocular symptoms were evaluated by the patients through the scale. |
| Secondary | Number of Follow-Up AEs (FUAE) | on or after Follow-Up Day 7 (FU1) | Follow-Up AEs (FUAE) were defined as TEAEs which start on or after Follow-Up Day 7 (FU1) visit |
| Secondary | Number of Ocular TEAEs by Eyes | On Day 1 (single dose scheme), Days 2-6 (multiple dose scheme), Day 7 (Follow-up [FU] 1), Day 8 (FU 2); Day 16 (FU 3), and Day 35-42 (FU 4) | Ocular TEAEs were defined as an adverse event (AE) interesting the study or the non-study eye, which started after the first dose of study treatment. These comprise ocular AEs during the treatment and follow-up period. For these AE, the number of events was provided for the study eye and the non-study eye, separately. |
| Secondary | Change From Baseline in Intraocular Pressure (IOP) by Eye Over All Visits | on Day -1 and at Day 8 (Follow up [FU] 2) and Day 16 (FU3) | IOP was performed using either Goldmann applanation tonometry after the instillation of a topical anaesthetic. IOP was measured in both eyes after completion of all other slit lamp examinations to avoid potential interference with the other evaluations. |
| Secondary | Change From Baseline in Visual Acuity Score for the Study Eye Over All Visits | On Day 1 (single dose scheme), Days 2,3,6 (multiple dose scheme), Day 7 (Follow-up [FU] 1), Day 8 (FU 2); Day 16 (FU 3) | Values of Best-Corrected Distance Visual Acuity (BCDVA) scores were measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) score. The ETDRS charts use letters, or a geometric progression in letter size from line to line, under standardized lighting conditions. The patient starts at the top of the chart, or on the last row where he or she can read all of the letters, and reads down the chart until he or she reaches a row where a minimum of three letters on a line cannot be read. The patient is scored by how many letters could be correctly identified. Therefore, the higher the number of letters the higher the visual acuity. Changes in the ETDRS score from baseline are summarised for the study eye. |
| Secondary | Change in Baseline in LogMAR [Derived as - Log (Snellen Equivalent Result)] for the Study Eye Over All Visits. | On Day 1 (single dose scheme), Days 2,3,6 (multiple dose scheme), Day 7 (Follow-up [FU] 1), Day 8 (FU 2); Day 16 (FU 3) | LogMAR is the logarithm of the minimal angle of resolution. The LogMAR was derived as - log (Snellen Equivalent result). LogMAR values range from 1.6 (20/800 Snellen Equivalent) to -0.2 (20/12 Snellen Equivalent). The lower the LogMAR value, the better the visual acuity. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Treatment Emergent Adverse Events (TEAEs). | On Day 1 (single dose scheme), Days 2-6 (multiple dose scheme), Day 7 (Follow-up [FU] 1), Day 8 (FU 2); Day 16 (FU 3), and Day 35-42 (FU 4) | The safety population is represented by randomized subjects who received a dose of study medication in at least one eye. All 30 randomized subjects were included in the Safety population. | events | NUMBER |
| PRIMARY | Number of Treatment Emergent Adverse Events During First Dose Schedule (TEAEs Dose 1). | During first dose schedule (TEAE Dose 1, which started after first dose of study treatment at Day 1 till before administration of the first dose at Treatment Day 2) | The safety population is represented by randomized subjects who received a dose of study medication in at least one eye. All 30 randomized subjects were included in the Safety population. | events | NUMBER |
| PRIMARY | Number of Treatment Emergent Adverse Events During Second Dose Schedule (TEAEs Dose 2). | During second dose schedule (TEAE Dose 2, which started on/after the first dose at Treatment Day 2 till before Follow-Up Day 7 (FU1) visit | The safety population is represented by randomized subjects who received a dose of study medication in at least one eye. All 30 randomized subjects were included in the Safety population. | events | NUMBER |
| PRIMARY | Change From Baseline in Visual Analogue Scale (VAS) Ocular Tolerability Score in Study Eye: Single Dose | at Treatment Day 2 pre-dose | score on a scale | MEAN | |
| PRIMARY | Change From Baseline in Visual Analogue Scale (VAS) Ocular Tolerability Score in Study Eye: Multiple Dose | at Day 2 8h, Day 3 predose, Day 6 pre-dose, Day 6 8h, Day 7 (FU1), Day 8 (FU2), Day 16 (FU3) | The safety population is represented by randomized subjects who received a dose of study medication in at least one eye. All 30 randomized subjects were included in the Safety population. | score on a scale | MEAN |
| SECONDARY | Number of Follow-Up AEs (FUAE) | on or after Follow-Up Day 7 (FU1) | The safety population is represented by randomized subjects who received a dose of study medication in at least one eye. All 30 randomized subjects were included in the Safety population. | events | NUMBER |
| SECONDARY | Number of Ocular TEAEs by Eyes | On Day 1 (single dose scheme), Days 2-6 (multiple dose scheme), Day 7 (Follow-up [FU] 1), Day 8 (FU 2); Day 16 (FU 3), and Day 35-42 (FU 4) | The safety population is represented by randomized subjects who received a dose of study medication in at least one eye. All 30 randomized subjects were included in the Safety population. | events | NUMBER |
| SECONDARY | Change From Baseline in Intraocular Pressure (IOP) by Eye Over All Visits | on Day -1 and at Day 8 (Follow up [FU] 2) and Day 16 (FU3) | The safety population is represented by randomized subjects who received a dose of study medication in at least one eye. All 30 randomized subjects were included in the Safety population | mmHg | MEAN |
| SECONDARY | Change From Baseline in Visual Acuity Score for the Study Eye Over All Visits | On Day 1 (single dose scheme), Days 2,3,6 (multiple dose scheme), Day 7 (Follow-up [FU] 1), Day 8 (FU 2); Day 16 (FU 3) | The safety population is represented by randomized subjects who received a dose of study medication in at least one eye. All 30 randomized subjects were included in the Safety population. | Letters | MEAN |
| SECONDARY | Change in Baseline in LogMAR [Derived as - Log (Snellen Equivalent Result)] for the Study Eye Over All Visits. | On Day 1 (single dose scheme), Days 2,3,6 (multiple dose scheme), Day 7 (Follow-up [FU] 1), Day 8 (FU 2); Day 16 (FU 3) | The safety population is represented by randomized subjects who received a dose of study medication in at least one eye. All 30 randomized subjects were included in the Safety population. | LogMAR | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group240
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs). | rhNGF 20μg/mL | 27 | events | ||
| Number of Treatment Emergent Adverse Events (TEAEs). | Placebo | 9 | events | ||
| Number of Treatment Emergent Adverse Events During First Dose Schedule (TEAEs Dose 1). | rhNGF 20μg/mL | 3 | events | ||
| Number of Treatment Emergent Adverse Events During First Dose Schedule (TEAEs Dose 1). | Placebo | 2 | events | ||
| Number of Treatment Emergent Adverse Events During Second Dose Schedule (TEAEs Dose 2). | rhNGF 20μg/mL | 16 | events | ||
| Number of Treatment Emergent Adverse Events During Second Dose Schedule (TEAEs Dose 2). | Placebo | 4 | events | ||
| Change From Baseline in Visual Analogue Scale (VAS) Ocular Tolerability Score in Study Eye: Single Dose | rhNGF 20μg/mL | 0.36 | Standard Deviation 1.325 | score on a scale | |
| Change From Baseline in Visual Analogue Scale (VAS) Ocular Tolerability Score in Study Eye: Single Dose | Placebo | 0.24 | Standard Deviation 0.410 | score on a scale | |
| Change From Baseline in Visual Analogue Scale (VAS) Ocular Tolerability Score in Study Eye: Multiple Dose | rhNGF 20μg/mL | Day 2 - 8h | 0.14 | Standard Deviation 0.882 | score on a scale |
| Change From Baseline in Visual Analogue Scale (VAS) Ocular Tolerability Score in Study Eye: Multiple Dose | Placebo | Day 2 - 8h | -0.09 | Standard Deviation 0.376 | score on a scale |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | rhNGF 20μg/mL | 20 | |
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | COMPLETED | rhNGF 20μg/mL | 20 | |
| Overall Study | COMPLETED | Placebo | 10 | |
| Overall Study | NOT COMPLETED | rhNGF 20μg/mL | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | rhNGF 20μg/mL | 2 | 20 | 2 |
| other | Alanine aminotransferase increased | Investigations | Placebo | 1 | 10 | 1 |
| other | Aspartate aminotransferase incresed | Investigations | rhNGF 20μg/mL | 2 | 20 | 2 |
| other | Aspartate aminotransferase incresed | Investigations | Placebo | 1 | 10 | 1 |
| other | Vital dye staining corneal present | Investigations | rhNGF 20μg/mL | 5 | 20 | 9 |
| other | Vital dye staining corneal present | Investigations | Placebo | 3 | 10 | 4 |
| other | Conjunctivitis | Infections and infestations | rhNGF 20μg/mL | 6 | 20 | 6 |
| other | Conjunctivitis | Infections and infestations | Placebo | 0 | 10 | 0 |
| other | Eye pain | Eye disorders | rhNGF 20μg/mL | 2 | 20 | 2 |
| other | Eye pain | Eye disorders | Placebo | 0 | 10 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | rhNGF 20μg/mL | 0 | 20 |
| Total, all-cause mortality | Placebo | 0 | 10 |
| Total, other adverse events | rhNGF 20μg/mL | 10 | 20 |
| Total, other adverse events | Placebo | 5 | 10 |
| Total, serious adverse events | rhNGF 20μg/mL | 0 | 20 |
| Total, serious adverse events | Placebo | 0 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| rhNGF 20μg/mL vs Placebo: deaths from any cause | Trial comparisons |
| rhNGF 20μg/mL vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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