Trial · NCT05978544
Safety and Preliminary Clinical Activity of Itolizumab in ARDS
NCT05978544, Phase 1, Unknown, Biotech Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Preliminary Clinical Activity of Itolizumab in ARDS. Trials, record NCT05978544. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05978544
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Preliminary Clinical Activity of Itolizumab in ARDS
- NCT number
- NCT05978544
- Status
- Unknown
- Phases
- Phase 1
- Enrollment
- 38 participants, estimated
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.
- Conditions
- Acute Respiratory Distress Syndrome
- Interventions
- Itolizumab
- First posted
- 2023-08-07
- Last updated
- 2023-08-07
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment Emergent Adverse Events | Study Day 58 | Number of subjects with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) V5.0 |
| Secondary | Maximum serum concentration of Itolizumab, Cmax | Study Day 30 | Maximum serum concentration of Itolizumab |
| Secondary | Minimum serum concentration of Itolizumab, Cmin | Study Day 30 | Minimum serum concentration of Itolizumab |
| Secondary | Time to maximum serum concentration of Itolizumab, Tmax | Study Day 30 | Time to maximum serum concentration of Itolizumab |
| Secondary | Total Itolizumab exposure across time, AUC0-t | Study Day 30 | Total Itolizumab exposure across time |
| Secondary | Half life of Itolizumab, t1/2 | Study Day 30 | Half life of Itolizumab |
| Secondary | Inflammatory Markers,IL-6 | Study Day 30 | IL-6 |
| Secondary | Inflammatory Markers,TNF-α | Study Day 30 | TNF-α |
| Secondary | Inflammatory Markers, hs-CRP | Study Day 30 | hs-CRP |
| Secondary | Inflammatory Markers,Serum ferritin | Study Day 30 | Serum ferritin |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 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/NCT05978544
GET https://conductscience.org/api/trials/v1/NCT05978544/registered?page=2