Trial · NCT03287310
First Time in Human (FTIH) Study to Evaluate Safety, Tolerability, Immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3511294 Administered Subcutaneously (SC) in Subjects With Mild to Moderate Asthma
NCT03287310, Phase 1, Completed, GlaxoSmithKline; results first posted 2021-03-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. First Time in Human (FTIH) Study to Evaluate Safety, Tolerability, Immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3511294 Administered Subcutaneously (SC) in Subjects With Mild to Moderate Asthma. Trials, record NCT03287310. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03287310
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
First Time in Human (FTIH) Study to Evaluate Safety, Tolerability, Immunogenicity, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3511294 Administered Subcutaneously (SC) in Subjects With Mild to Moderate Asthma
- NCT number
- NCT03287310
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 50 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Asthma
- Interventions
- GSK3511294, Placebo, Salbutamol/albuterol
- First posted
- 2017-09-19
- Last updated
- 2021-03-01
- Other registries' IDs
- eudract:2016-004256-30
- Results first posted
- 2021-03-01
Source ClinicalTrials.gov
Registered outcomes59
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) and Serious AEs (SAE) | Up to Week 40 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; other important medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed before; is associated with liver injury and impaired liver function. |
| Primary | Number of Participants With Adverse Events of Special Interest (AESI) | Up to Week 40 | AESIs were defined as Hypersensitivity (narrow) and Injection site reactions like hematoma and swelling. |
| Primary | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Blood samples were collected at indicated time-points for analysis of hematology parameters like platelet count, neutrophils, lymphocytes, monocytes, eosinophils and basophils. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Primary | Change From Baseline in Red Blood Cell Count (RBC) | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Blood samples were collected at indicated time-points for analysis of hematology parameters like RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Primary | Change From Baseline in Mean Corpuscle Volume (MCV) | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Blood samples were collected at indicated time-points for analysis of hematology parameters like MCV. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Primary | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Blood samples were collected at indicated time-points for analysis of hematology parameters like MCH. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Primary | Change From Baseline in Hemoglobin | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Blood samples were collected at indicated time-points for analysis of hematology parameters like hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Primary | Change From Baseline in Hematocrit | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Blood samples were collected at indicated time-points for analysis of hematology parameters like hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Primary | Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP) | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Blood samples were collected at indicated time-points for analysis of clinical parameters like hsCRP. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Primary | Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Blood samples were collected at indicated time-points for analysis of clinical parameters like total protein and albumin. Baseline was defined as latest pre-dose assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 registered outcomesOutcomes59
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious AEs (SAE) | Up to Week 40 | Safety Population comprised of all randomized participants who received at least one dose of the study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Events of Special Interest (AESI) | Up to Week 40 | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Giga cells per liter | MEAN |
| PRIMARY | Change From Baseline in Red Blood Cell Count (RBC) | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Trillion cells per liter | MEAN |
| PRIMARY | Change From Baseline in Mean Corpuscle Volume (MCV) | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Femtoliters | MEAN |
| PRIMARY | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Picograms | MEAN |
| PRIMARY | Change From Baseline in Hemoglobin | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Grams per liter | MEAN |
| PRIMARY | Change From Baseline in Hematocrit | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Proportion of red blood cells in blood | MEAN |
| PRIMARY | Change From Baseline in Clinical Chemistry Parameter: High Sensitivity C-reactive Protein (hsCRP) | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Milligrams per liter | MEAN |
| PRIMARY | Change From Baseline in Clinical Chemistry Parameter of Total Protein and Albumin | Baseline and at Days 2, 3, 4 and 5, Weeks 1, 2, 4, 8, 12, 18, 24, 26, 32, 36 and 40 | Safety Population. Only those participants with planned assessments at that particular time point has been presented (represented by n= X in the category titles). | Grams per liter | MEAN |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 outcomesResults by group3,509
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAE) | Placebo | Any AE | 11 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAE) | GSK3511294 2mg | Any AE | 2 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAE) | GSK3511294 10mg | Any AE | 6 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAE) | GSK3511294 30mg | Any AE | 8 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAE) | GSK3511294 100mg | Any AE | 9 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAE) | GSK3511294 300mg | Any AE | 4 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAE) | Placebo | Any SAE | 0 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAE) | GSK3511294 2mg | Any SAE | 0 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAE) | GSK3511294 10mg | Any SAE | 0 | Participants | |
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAE) | GSK3511294 30mg | Any SAE | 0 | Participants |
1 to 10 of 3,509Source ClinicalTrials.gov
See all 3,509 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | STARTED | GSK3511294 2 mg | 6 | |
| Overall Study | STARTED | GSK3511294 10 mg | 6 | |
| Overall Study | STARTED | GSK3511294 30 mg | 9 | |
| Overall Study | STARTED | GSK3511294 100 mg | 9 | |
| Overall Study | STARTED | GSK3511294 300 mg | 6 | |
| Overall Study | COMPLETED | Placebo | 12 | |
| Overall Study | COMPLETED | GSK3511294 2 mg | 6 | |
| Overall Study | COMPLETED | GSK3511294 10 mg | 6 | |
| Overall Study | COMPLETED | GSK3511294 30 mg | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events402
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 | Nasopharyngitis | Infections and infestations | Placebo | 2 | 12 | 3 |
| other | Nasopharyngitis | Infections and infestations | GSK3511294 2mg | 2 | 6 | 4 |
| other | Nasopharyngitis | Infections and infestations | GSK3511294 10mg | 1 | 6 | 1 |
| other | Nasopharyngitis | Infections and infestations | GSK3511294 30mg | 3 | 9 | 3 |
| other | Nasopharyngitis | Infections and infestations | GSK3511294 100mg | 5 | 9 | 5 |
| other | Nasopharyngitis | Infections and infestations | GSK3511294 300mg | 2 | 6 | 2 |
| other | Rhinitis | Infections and infestations | Placebo | 3 | 12 | 3 |
| other | Rhinitis | Infections and infestations | GSK3511294 2mg | 0 | 6 | 0 |
| other | Rhinitis | Infections and infestations | GSK3511294 10mg | 1 | 6 | 1 |
| other | Rhinitis | Infections and infestations | GSK3511294 30mg | 1 | 9 | 1 |
1 to 10 of 402Source ClinicalTrials.gov
See all 402 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 12 |
| Total, all-cause mortality | GSK3511294 2mg | 0 | 6 |
| Total, all-cause mortality | GSK3511294 10mg | 0 | 6 |
| Total, all-cause mortality | GSK3511294 30mg | 0 | 9 |
| Total, all-cause mortality | GSK3511294 100mg | 0 | 9 |
| Total, all-cause mortality | GSK3511294 300mg | 0 | 6 |
| Total, other adverse events | Placebo | 11 | 12 |
| Total, other adverse events | GSK3511294 2mg | 2 | 6 |
| Total, other adverse events | GSK3511294 10mg | 6 | 6 |
| Total, other adverse events | GSK3511294 30mg | 8 | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34292606 | DERIVED |
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/NCT03287310
GET https://conductscience.org/api/trials/v1/NCT03287310/registered?page=2