Trial · NCT07903337
A Phase 1, Open-Label, Two-Stage, Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-1071 Under Fasted or Fed Conditions in Healthy Volunteers
NCT07903337, Phase 1, Not yet recruiting, Elixiron Immunotherapeutics Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 1, Open-Label, Two-Stage, Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-1071 Under Fasted or Fed Conditions in Healthy Volunteers. Trials, record NCT07903337. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07903337
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1, Open-Label, Two-Stage, Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-1071 Under Fasted or Fed Conditions in Healthy Volunteers
- NCT number
- NCT07903337
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 25 participants, estimated
- Lead sponsor
- Elixiron Immunotherapeutics Inc.
- Conditions
- Food Effect in Healthy Volunteers
- Interventions
- EI-1071
- First posted
- 2026-10-29
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Stage 1 Area under the curve [AUC] from time 0 to the last quantifiable time [AUC0-t] | Day 1 to Day 4 of each single dose period | |
| Primary | Stage 1 AUC from time 0 to infinity [AUC0-∞], and maximum concentration [Cmax] | Day 1 to Day 4 of each single dose period | |
| Primary | Stage 1 Time to Cmax (Tmax) | Day 1 to Day 4 of each single dose period | |
| Primary | Stage 1 Half-life (t1/2) | Day 1 to Day 4 of each single dose period | |
| Primary | Stage 1 Apparent clearance (CL/F) | Day 1 to Day 4 of each single dose period | |
| Primary | Stage 1 Apparent volume of distribution (Vz/F) | Day 1 to Day 4 of each single dose period | |
| Primary | Stage 2 Incidence and severity of TEAEs and TESAEs, | From Day 1 to Day 21 (EOS visit) | |
| Primary | Stage 2 Physical examination | Screening, Day -1, Day 21 | |
| Primary | Stage 2 Vital signs | Screening, Day -1 to Day 21 | |
| Primary | Stage 2 Laboratory tests | Screening, Day -1, Day 7, Day 14, Day 21 | Hematology, biochemistry, urinalysis, and coagulation |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 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.
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/NCT07903337
GET https://conductscience.org/api/trials/v1/NCT07903337/registered?page=2