Healthy VolunteersPhase 1NCT04366349
A Study to Evaluate the Safety and Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Melrilimab (GSK3772847) in Healthy Participants
A Phase 1 study testing melrilimab (GSK3772847) 70 milligram (mg) and melrilimab (GSK3772847) 140 milligram (mg) in people with Healthy Volunteers and Asthma, run by GlaxoSmithKline at 1 site in United States.
Trial summary
GSK3772847, an anti-interleukin (IL) 33-receptor monoclonal antibody, is a novel treatment for asthma. The purpose of this study to evaluate the safety and tolerability, PK and PD of single ascending doses of GSK3772847 administered subcutaneously (SC) to healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Asthma
- What is being tested?
- melrilimab (GSK3772847) 70 milligram (mg) and melrilimab (GSK3772847) 140 milligram (mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2020to 21 Dec 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants age in between 18 to 65 years, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A participant with a clinical abnormality or laboratory parameters not specifically listed in the exclusion criteria that is outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor (if required), agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or results.
- Japanese participants are eligible based on meeting all of the following criteria: healthy male and female participants born in Japan; are descendants of four ethnic Japanese grandparents and two ethnic Japanese parents; holding a Japanese passport or identity papers; being able to speak Japanese; have lived outside Japan for less than 10 years at the time of screening.
- Chinese Participants are eligible based on meeting all of the following: healthy male and female participants born in mainland China; are descendants of four Chinese grandparents and two Chinese parents; holding a Chinese passport or identity papers; being able to speak Chinese; have lived outside China for less than 10 years at the time of screening; Body weight 35-150 kilogram (kg) and body mass index (BMI) within the range 18-32 kilogram per square meter (kg/m2) (inclusive).
- Female participant: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies; is not a woman of childbearing potential (WOCBP) or is a WOCBP and using an acceptable contraceptive method during the intervention period (at a minimum until after the last dose of study intervention); the investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention; a WOCBP must have a negative highly sensitive pregnancy test ([urine] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required,. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive; additional requirements for pregnancy testing during and after study intervention are located; The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Alanine transaminase (ALT) >2 times of (x) upper limit of normal (ULN).
- Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Ongoing or recurrent infections.
- QT interval corrected for heart rate by Fridericia's formula (QTcF) >450 millisecond (msec) or any of the following abnormal and clinically significant electrocardiogram (ECG) findings; sinus bradycardia <45 beats per minute (bpm); sinus tachycardia >=110 bpm; multifocal atrial tachycardia (wandering atrial pacemaker with rate >100 bpm); evidence of Mobitz II second degree or third degree atrioventricular (AV) block; pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolt (mV) (4 millimeter (mm) with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5 mV [5 mm with 10mm/mV setting], appearing in at least two contiguous leads; Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes; For participants without complete right bundle branch block: QT interval corrected for heart rate by Fridericia's formula (QTc[F]) >=450 msec or an ECG that is unsuitable for QT measurements (e.g., poor defined termination of the T wave); for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements (e.g., poor defined termination of the T wave); ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities); Clinically significant conduction abnormalities (e.g., Wolff-Parkinson-White syndrome or bifascicular block defined as complete left bundle branch block or complete right bundle branch block with concomitant left fascicular block); Clinically significant arrhythmias (e.g., atrial fibrillation with rapid ventricular response, ventricular tachycardia).
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including saint [St] John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) before the first dose of study medication and until study completion, unless in the opinion of the investigator and GlaxoSmithKline (GSK) Medical Monitor the medication will not interfere with the study procedures or compromise participant safety.
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- The participant has been in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Presence of Hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
- Positive Hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
- Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention.
- A positive test for human immunodeficiency virus (HIV) antibody.
- Where participation in the study would result in donation of blood or blood products in excess of 500 milliliter (mL) within 3 months.
- A positive pre-study drug/alcohol screen.
- Any history of substance abuse or a positive test for drugs of abuse at screening or admission.
- Known, pre-existing parasitic infestations within 6 months prior to Screening.
- Vaccinated with live or attenuated vaccines within 4 weeks prior to receiving investigational product (IP) and up to 6 months after dose administration of GSK3772847.
- A positive highly sensitive pregnancy test (urine or serum as required by local regulations) at screening.
- Positive urinary cotinine test indicative of smoking history at screening or each in-house admission to the clinical research unit or regular use of tobacco- or nicotine-containing products (e.g. nicotine patches or vaporizing devices) within 6 months prior to screening.
- Participants with allergy or intolerance to a monoclonal antibody or biologic or to any components of the formulation used in this study.
- A vulnerable participant. defined as individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
- Participants who work for the Sponsor, contract research organization (CRO), or one of the study centers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Single Ascending Dose Study to Determine the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3772847 Administered Subcutaneously in Healthy Participants
GSK3772847, an anti-interleukin (IL) 33-receptor monoclonal antibody, is a novel treatment for asthma. The purpose of this study to evaluate the safety and tolerability, PK and PD of single ascending doses of GSK3772847 administered subcutaneously (SC) to healthy participants. This study will also establish the bioavailability of SC formulation and evaluate the safety in particular injection site tolerability of route. Participants will either receive a single dose of 70 milligram (mg) GSK3772847 or placebo in (Cohort 1) and 140 mg GSK3772847 or placebo in Cohorts 2, 3 (Japanese participants) and 4 (Chinese participants). The site of injection will be upper arm; abdomen or thigh for cohorts 1 and 2 with cohorts 3 and 4 will receive injections in the upper arm only. Approximately, the total duration of study will be up to 89 days.
- Conditions
- Healthy Volunteers, Asthma
- Being tested
- melrilimab (GSK3772847) 70 milligram (mg), melrilimab (GSK3772847) 140 milligram (mg), Placebo
- Keywords
- Pharmacokinetics, Pharmacodynamics, Safety, GSK3772847, Tolerability
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
melrilimab (GSK3772847) 70 milligram (mg)Biological
melrilimab (GSK3772837) will be available at a dose strength of 70 milligram per milliliter (mg/mL) in a 3 milliliter (mL) glass vial.
melrilimab (GSK3772847) 140 milligram (mg)Biological
Two doses of melrilimab (GSK3772837) 70 milligram per milliliter (mg/mL) will be administered to achieve a dose strength of 140 milligram per milliliter (mg/mL)
PlaceboOther
Placebo to match melrilimab (GSK3772847) will be available in the form of solution for injection in a 3 milliliter (mL) glass vial.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving melrilimab (GSK3772847) 70 milligram (mg) | Experimental | Participants will receive a single dose of melrilimab (GSK3772847) 70 milligram (mg) subcutaneously (SC) injection by an health care professional (HCP). Receives: Biological: melrilimab (GSK3772847) 70 milligram (mg) |
| Participants receiving melrilimab (GSK3772847) 140 milligram (mg) | Experimental | Participants will receive a single dose of melrilimab (GSK3772847) 140 milligram (mg) subcutaneously (SC) injection by an health care professional (HCP). Receives: Biological: melrilimab (GSK3772847) 140 milligram (mg) |
| Participants receiving Placebo | Placebo comparator | Participants will receive a single dose of placebo subcutaneously (SC) injection by an health care professional (HCP). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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. A 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 or significant disability/incapacity, is a congenital anomaly/birth defect, and other situations which involve medical or scientific judgment.
Measured: Up to Day 85
Area Under the Plasma Concentration Time Curve From 0 to t (AUC[0-t]) of GSK3772847
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847. Pharmacokinetic Population consisted of all randomized participants who received at least one dose of study treatment, and for whom at least one pharmacokinetic sample was obtained, analyzed and measurable.
Measured: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85
Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC[0-infinity]) of GSK3772847
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
Measured: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85
Maximum Observed Plasma Concentration (Cmax) of GSK3772847
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
Measured: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85
Time to Cmax (Tmax) of GSK3772847
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
Measured: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85
Apparent Terminal Half-life (t1/2) of GSK3772847
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
Measured: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85
Secondary outcomes (4)
Maximal Decrease in Ratio to Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration
Blood samples were collected to measure free soluble ST2 concentration. Maximal decrease from Baseline was the largest decrease calculated across all time points post dose. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Baseline was the most recent recorded value before dosing on Day 1 (Pre-dose). Pharmacodynamic Population consisted of all randomized participants who received at least one dose of study treatment, and for whom at least one pharmacokinetic sample was obtained, analyzed and measurable.
Measured: Baseline and up to Day 85/early withdrawal
Maximal Increase in Ratio to Baseline in Total Soluble ST2 Concentration
Blood samples were collected to measure total soluble ST2 concentration. Maximal increase from Baseline was the largest increase calculated across all timepoints post dose. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Baseline was the most recent recorded value before dosing on Day 1 (Pre-dose).
Measured: Baseline and up to Day 85/early withdrawal
Number of Participants With Confirmed Positive Anti-GSK3772847 Antibodies
Serum samples were collected at indicated time points and analyzed for the presence of anti-GSK3772847 antibodies using a tiered approach including a screening assay, a confirmation assay and calculation of titer.
Measured: Days 1, 15, 29, 57 and 85/early withdrawal
Ratio to Baseline in Plasma 4 Beta-hydroxy (4BetaOH) Cholesterol/Cholesterol
Blood samples were collected at indicated time points to measure 4BetaOH cholesterol/cholesterol. Ratio to Baseline is defined as post-dose visit value divided by Baseline value. Baseline value was the latest pre-dose assessment (Day 1 Pre-dose).
Measured: Baseline, Days 5, 15, 29 and 85/early withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start21 Jul 2020
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This is a single arm study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366349
- Sponsor's protocol ID
- 209635
- Status last verified
- Sep 2021
- First submitted
- 27 Apr 2020
- Last updated
- 5 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Pefani E, Stone S, Zhu CQ, Nunn C, Fairman D. Safety, tolerability, and pharmacokinetics of a single ascending subcutaneous dose of GSK3772847 in healthy participants. Pharmacol Res Perspect. 2023 Apr;11(2):e01054. doi: 10.1002/prp2.1054.
PubMed 36846967
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single Ascending Dose Study to Determine the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of GSK3772847 Administered Subcutaneously in Healthy Participants
- ClinicalTrials.gov ID
- NCT04366349
- Acronym / sponsor ID
- 209635
- Conditions
- Healthy Volunteers, Asthma
- Keywords
- Pharmacokinetics, Pharmacodynamics, Safety, GSK3772847, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Posted 5 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GSK3772847, an anti-interleukin (IL) 33-receptor monoclonal antibody, is a novel treatment for asthma. The purpose of this study to evaluate the safety and tolerability, PK and PD of single ascending doses of GSK3772847 administered subcutaneously (SC) to healthy participants. This study will also establish the bioavailability of SC formulation and evaluate the safety in particular injection site tolerability of route. Participants will either receive a single dose of 70 milligram (mg) GSK3772847 or placebo in (Cohort 1) and 140 mg GSK3772847 or placebo in Cohorts 2, 3 (Japanese participants) and 4 (Chinese participants). The site of injection will be upper arm; abdomen or thigh for cohorts 1 and 2 with cohorts 3 and 4 will receive injections in the upper arm only. Approximately, the total duration of study will be up to 89 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This is a single arm study.
| Arm | Type | Receives |
|---|---|---|
| Participants receiving melrilimab (GSK3772847) 70 milligram (mg) | Experimental | Biological: melrilimab (GSK3772847) 70 milligram (mg)Participants will receive a single dose of melrilimab (GSK3772847) 70 milligram (mg) subcutaneously (SC) injection by an health care professional (HCP). |
| Participants receiving melrilimab (GSK3772847) 140 milligram (mg) | Experimental | Biological: melrilimab (GSK3772847) 140 milligram (mg)Participants will receive a single dose of melrilimab (GSK3772847) 140 milligram (mg) subcutaneously (SC) injection by an health care professional (HCP). |
| Participants receiving Placebo | Placebo comparator | Other: PlaceboParticipants will receive a single dose of placebo subcutaneously (SC) injection by an health care professional (HCP). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants age in between 18 to 65 years, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A participant with a clinical abnormality or laboratory parameters not specifically listed in the exclusion criteria that is outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor (if required), agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures or results.
- Japanese participants are eligible based on meeting all of the following criteria: healthy male and female participants born in Japan; are descendants of four ethnic Japanese grandparents and two ethnic Japanese parents; holding a Japanese passport or identity papers; being able to speak Japanese; have lived outside Japan for less than 10 years at the time of screening.
- Chinese Participants are eligible based on meeting all of the following: healthy male and female participants born in mainland China; are descendants of four Chinese grandparents and two Chinese parents; holding a Chinese passport or identity papers; being able to speak Chinese; have lived outside China for less than 10 years at the time of screening; Body weight 35-150 kilogram (kg) and body mass index (BMI) within the range 18-32 kilogram per square meter (kg/m2) (inclusive).
- Female participant: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies; is not a woman of childbearing potential (WOCBP) or is a WOCBP and using an acceptable contraceptive method during the intervention period (at a minimum until after the last dose of study intervention); the investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention; a WOCBP must have a negative highly sensitive pregnancy test ([urine] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required,. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive; additional requirements for pregnancy testing during and after study intervention are located; The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Key exclusion criteria (22 listed)
- Alanine transaminase (ALT) >2 times of (x) upper limit of normal (ULN).
- Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Ongoing or recurrent infections.
- QT interval corrected for heart rate by Fridericia's formula (QTcF) >450 millisecond (msec) or any of the following abnormal and clinically significant electrocardiogram (ECG) findings; sinus bradycardia <45 beats per minute (bpm); sinus tachycardia >=110 bpm; multifocal atrial tachycardia (wandering atrial pacemaker with rate >100 bpm); evidence of Mobitz II second degree or third degree atrioventricular (AV) block; pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 millivolt (mV) (4 millimeter (mm) with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5 mV [5 mm with 10mm/mV setting], appearing in at least two contiguous leads; Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes; For participants without complete right bundle branch block: QT interval corrected for heart rate by Fridericia's formula (QTc[F]) >=450 msec or an ECG that is unsuitable for QT measurements (e.g., poor defined termination of the T wave); for participants with complete right bundle branch block: QTc(F) >=480 msec or an ECG that is unsuitable for QT measurements (e.g., poor defined termination of the T wave); ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities); Clinically significant conduction abnormalities (e.g., Wolff-Parkinson-White syndrome or bifascicular block defined as complete left bundle branch block or complete right bundle branch block with concomitant left fascicular block); Clinically significant arrhythmias (e.g., atrial fibrillation with rapid ventricular response, ventricular tachycardia).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| melrilimab (GSK3772847) 70 milligram (mg)melrilimab (GSK3772837) will be available at a dose strength of 70 milligram per milliliter (mg/mL) in a 3 milliliter (mL) glass vial. | Biological | Participants receiving melrilimab (GSK3772847) 70 milligram (mg) |
| melrilimab (GSK3772847) 140 milligram (mg)Two doses of melrilimab (GSK3772837) 70 milligram per milliliter (mg/mL) will be administered to achieve a dose strength of 140 milligram per milliliter (mg/mL) | Biological | Participants receiving melrilimab (GSK3772847) 140 milligram (mg) |
| PlaceboPlacebo to match melrilimab (GSK3772847) will be available in the form of solution for injection in a 3 milliliter (mL) glass vial. | Other | Participants receiving Placebo |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 85
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. A 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 or significant disability/incapacity, is a congenital anomaly/birth defect, and other situations which involve medical or scientific judgment.
Area Under the Plasma Concentration Time Curve From 0 to t (AUC[0-t]) of GSK3772847
Time frame: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847. Pharmacokinetic Population consisted of all randomized participants who received at least one dose of study treatment, and for whom at least one pharmacokinetic sample was obtained, analyzed and measurable.
Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC[0-infinity]) of GSK3772847
Time frame: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
Maximum Observed Plasma Concentration (Cmax) of GSK3772847
Time frame: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
Time to Cmax (Tmax) of GSK3772847
Time frame: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
Apparent Terminal Half-life (t1/2) of GSK3772847
Time frame: Day 1: Pre-dose, 2, 4, 8 hours post-dose; Days 2, 3, 4, 5, 6, 9, 15, 29, 43, 57, 71 and 85
Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3772847.
4 secondary outcomes
Maximal Decrease in Ratio to Baseline in Free Soluble Suppressor of Tumorigenicity 2 (ST2) Concentration
Time frame: Baseline and up to Day 85/early withdrawal
Maximal Increase in Ratio to Baseline in Total Soluble ST2 Concentration
Time frame: Baseline and up to Day 85/early withdrawal
Number of Participants With Confirmed Positive Anti-GSK3772847 Antibodies
Time frame: Days 1, 15, 29, 57 and 85/early withdrawal
Ratio to Baseline in Plasma 4 Beta-hydroxy (4BetaOH) Cholesterol/Cholesterol
Time frame: Baseline, Days 5, 15, 29 and 85/early withdrawal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36846967Pefani E, Stone S, Zhu CQ, Nunn C, Fairman D. Safety, tolerability, and pharmacokinetics of a single ascending subcutaneous dose of GSK3772847 in healthy participants. Pharmacol Res Perspect. 2023 Apr;11(2):e01054. doi: 10.1002/prp2.1054.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing melrilimab (GSK3772847) 70 milligram (mg) and melrilimab (GSK3772847) 140 milligram (mg) in people with Healthy Volunteers and Asthma, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to Day 85). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04366349, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021; AzTrials last refreshed its copy on 1 Nov 2026.