Trial · NCT04015076
Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid
NCT04015076, Phase 1, Completed, Inflazome UK Ltd
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid. Trials, record NCT04015076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04015076
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid
- NCT number
- NCT04015076
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 80 participants, actual
- Lead sponsor
- Inflazome UK Ltd
- Conditions
- Healthy
- Interventions
- Inzomelid, Placebo
- First posted
- 2019-07-10
- Last updated
- 2020-03-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of treatment emergent advert events [Safety and Tolerability] | Day 1-8 for SAD, Day 1-16 for MAD | Incidence, frequency and severity of treatment emergent advert events |
| Primary | Peak Plasma Concentration (Cmax)-single dose | Day 1-3 | Peak plasma concentration following single dose administration |
| Primary | Area under the plasma concentration versus time curve (AUC)- single dose | Day 1-3 | AUC following single dose administration |
| Primary | Peak Plasma Concentration (Cmax)-multiple dose | Days 1-9 | Peak plasma concentration following multiple dose administration |
| Primary | Area under the plasma concentration versus time curve (AUC)- multiple dose | Days 1-9 | AUC following multiple dose administration |
| Primary | Peak Plasma Concentration (Cmax)-multiple dose | Days 1-16 | Peak plasma concentration following multiple dose administration |
| Primary | Area under the plasma concentration versus time curve (AUC)- multiple dose | Days 1-16 | AUC following multiple dose administration |
| Secondary | Pharmacodynamic activity | Day 1-3 for SAD and Day 1-9 for MAD | NLRP3 Inhibition in whole blood |
| Secondary | Reduction in CAPS symptom scores | Days 1-15 | Reduction in Physician Assessed CAPS scores based on 8 point questionnaire |
Source ClinicalTrials.gov
Outcomes0
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.
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 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/NCT04015076
GET https://conductscience.org/api/trials/v1/NCT04015076/registered