Trial · NCT03487263
Dose-Escalation, Safety and Pharmacokinetic Study of IC14 in Motor Neurone Disease
NCT03487263, Phase 1, Completed, Implicit Bioscience
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose-Escalation, Safety and Pharmacokinetic Study of IC14 in Motor Neurone Disease. Trials, record NCT03487263. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03487263
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-Escalation, Safety and Pharmacokinetic Study of IC14 in Motor Neurone Disease
- NCT number
- NCT03487263
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- Implicit Bioscience
- Conditions
- Motor Neuron Disease, Amyotrophic Lateral Sclerosis
- Interventions
- IC14
- First posted
- 2018-04-04
- Last updated
- 2025-08-20
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of treatment-emergent adverse events (safety, tolerability) | one month | Number of participants with treatment-emergent adverse events (safety, tolerability) classified by MedDRA |
| Secondary | Treatment-related change in ALSFRS-R functional scale | one month | Treatment-related change in Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) \[0 (worst) to 48 (best)\] |
| Secondary | Respiratory function | one month | Treatment-related change in percent normal Forced Vital Capacity \[0% (worst) to 100% (best)\] |
| Secondary | Muscle function | one month | Treatment-related change in percent normal Sniff Nasal Pressure \[0% (worst) to 100% (best)\] |
| Secondary | Quality of life measured by ALSSQOL | one month | Treatment-related change in Amyotrophic Lateral Sclerosis Specific Quality of Life - Revised (ALSSQOL-R) \[0 (worst) to 460 (best)\] |
| Secondary | Patient-reported outcome | one month | Treatment-related change Edinburgh Cognitive and Behavioural Assessment Score (ECAS) \[0 (worst) to 136 (best)\] |
| Secondary | Maximum Plasma Concentration (Cmax) | one month | Maximum serum IC14 concentration (micrograms per milliliter) |
| Secondary | Area Under the Curve (AUC) | one month | Area Under the Curve for serum IC14 (microgram x hr/mL) |
| Secondary | Monocyte CD14 Receptor Occupancy | one month | Treatment-related change in percent monocyte CD14 receptor occupancy as a pharmacodynamic marker |
| Secondary | Urinary p75 neurotrophin receptor (biomarker) | one month | Treatment-related change in urinary concentration of urinary p75 neurotrophin receptor (NTR) (nanograms per milligram creatinine) |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34678870 | RESULT |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
GET https://conductscience.org/api/trials/v1/NCT03487263
GET https://conductscience.org/api/trials/v1/NCT03487263/registered