Pulmonary Disease, Chronic ObstructivePhase 1NCT06154837
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
A Phase 1 study testing GSK3862995B in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 31 sites in 3 countries.
Trial summary
The primary objective of the study is to investigate the safety and tolerability of ascending doses of GSK3862995B following single dose in healthy participants and repeat doses in participants with Chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- GSK3862995B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 31 sitesin 3 countries
- Study dates
- 27 Nov 2023to 16 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants (Part A)
- Participant must be 18 to 65 years of age inclusive.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Body weight within the range 50-110 kilogram (kg) (inclusive)
- Body mass index (BMI) within the range 19.5-32 kilogram per square meter (kg/m^2)
- Male and/or female of non-childbearing potential
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- Participants with Chronic Obstructive Pulmonary Disorder (COPD) (Part B)
- Participant must be 40 to 75 years of age inclusive.
- Body weight within the range 50-110 kg (inclusive)
- BMI within the range 19.5-32 kg/m^2
- Participant has a confirmed diagnosis of COPD for greater than (>)12 months
- Participants must present with a measured post-salbutamol Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio of less than (<) 0.70 at screening to confirm the diagnosis of COPD and a measured post-salbutamol FEV1 greater than or equal to (>=) 40% of predicted normal values.
- Participants must have a well-documented requirement for optimized standard of care background therapy that includes daily inhaled medication.
- A peripheral blood eosinophil count of >=150 cells/microliter (mcL) at screening
- Former cigarette smokers with a history of cigarette smoking of >=10 pack-years at screening current smokers (includes the use of any type of nicotine containing product), or non-smokers are permitted
- Male and/or female of non-childbearing potential.
Who cannot join
- Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgement of the Investigator, may affect participant safety or affect study endpoints.
- A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug, including both serious local infection (for example, cellulitis, abscess) or systemic infection (for example, pneumonia, tuberculosis, hepatitis B, shingles).
- Significant allergies to humanized monoclonal antibodies.
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Breast cancer within the past 10 years
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- Alanine transaminase (ALT) >1x upper limit of normal (ULN)
- Total bilirubin >1.5xULN (isolated total bilirubin >1.5xULN is acceptable if total bilirubin is fractionated and direct bilirubin less than (<) 35%).
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A clinically significant abnormality in 12-lead ECG readings performed at screening
- A clinically significant abnormality in the Holter monitor performed at screening (IV cohorts only).
Trial locations and contacts
31 sites in 3 countries.
31 sites in 3 countries
Germany13 sites
GSK Investigational Site
Ahrensburg, 22926
GSK Investigational Site
Berlin, 10117
GSK Investigational Site
Berlin, 10119
GSK Investigational Site
Berlin, 14050
GSK Investigational Site
Dresden, 01069
GSK Investigational Site
Frankfurt, 60596
GSK Investigational Site
Hamburg, 20253
GSK Investigational Site
Hamburg, Hamburg
GSK Investigational Site
Hanover, Lower Saxony, 30159
GSK Investigational Site
Leipzig, 04207
GSK Investigational Site
Lübeck, 23552
GSK Investigational Site
Mainz, 55128
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055
United States10 sites
GSK Investigational Site
Austin, Texas, 78744
GSK Investigational Site
Columbus, Georgia, 31904
GSK Investigational Site
Hialeah, Florida, 33016
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Orange City, Florida, 32763
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Plantation, Florida, 33324-7006
GSK Investigational Site
Rock Hill, South Carolina, 29732
GSK Investigational Site
Shelby, North Carolina, 28150
GSK Investigational Site
Yuma, Arizona, 85365
United Kingdom8 sites
GSK Investigational Site
Barnsley, S75 3DL
GSK Investigational Site
Blackpool, Lancashire, FY2 0JH
GSK Investigational Site
Cambridge, CB2 0GG
GSK Investigational Site
Cannock, WS11 0BN
GSK Investigational Site
Harrow, Middlesex, HA1 3UJ
GSK Investigational Site
London
GSK Investigational Site
Manchester, M23 9QZ
GSK Investigational Site
West Yorkshire, LS10 1DU
About this study
Official title: A Two-part Phase 1 Randomized, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of GSK3862995B Following Single Ascending Doses in Healthy Participants and Repeat Doses in Participants With Chronic Obstructive Pulmonary Disease
The primary objective of the study is to investigate the safety and tolerability of ascending doses of GSK3862995B following single dose in healthy participants and repeat doses in participants with Chronic obstructive pulmonary disease (COPD).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- GSK3862995B, Placebo
- Keywords
- GSK3862995B, Chronic Obstructive Pulmonary Disease, Phase 1
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK3862995BDrug
GSK3862995B will be administered.
PlaceboDrug
Placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose Level 1: Single dose of GSK3862995B | Experimental | Healthy participants will receive single dose of GSK3862995B. Receives: Drug: GSK3862995B |
| Part A Dose Level 2: Single dose of GSK3862995B | Experimental | Healthy participants will receive single dose of GSK3862995B. Receives: Drug: GSK3862995B |
| Part A Dose Level 3: Single dose of GSK3862995B | Experimental | Healthy participants will receive single dose of GSK3862995B. Receives: Drug: GSK3862995B |
| Part A Dose Level 4: Single dose of GSK3862995B | Experimental | Healthy participants will receive single dose of GSK3862995B. Receives: Drug: GSK3862995B |
| Part A Dose Level 5: Single dose of GSK3862995B | Experimental | Healthy participants will receive single dose of GSK3862995B. Receives: Drug: GSK3862995B |
| Part A Dose Level 6: Single dose of GSK3862995B | Experimental | Healthy participants will receive single dose of GSK3862995B. Receives: Drug: GSK3862995B |
| Part A: Placebo | Placebo comparator | Healthy participants will receive single dose of placebo. Receives: Drug: Placebo |
| Part B: Repeat dose of GSK3862995B | Experimental | Participants with COPD will receive repeat doses of GSK3862995B. Receives: Drug: GSK3862995B |
| Part B: Placebo | Placebo comparator | Participants with COPD will receive repeat doses of placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: 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 treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
Measured: Up to 36 weeks
Part B: Number of Participants with AEs and SAEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
Measured: Up to 48 weeks
Part A: Number of Participants with Clinically significant changes in laboratory values
Number of Participants with clinically significant changes in laboratory values (haematology, chemistry, and urinalysis) will be assessed.
Measured: Up to 28 weeks
Part A: Number of Participants with Clinically Significant Change in vital signs
Number of participants with clinically significant change in vital signs (tympanic temperature, pulse rate, respiratory rate, and blood pressure) will be assessed.
Measured: Up to 28 weeks
Part A: Number of Participants with Clinically Significant Change in 12-lead Electrocardiogram (ECG) Parameters
Number of participants with clinically significant change in 12-lead ECG parameters will be assessed.
Measured: Up to 28 weeks
Part B: Number of Participants with Clinically significant changes in laboratory values (haematology, chemistry and urinalysis)
Number of Participants with clinically significant changes in laboratory values (haematology, chemistry and urinalysis) will be assessed.
Measured: Up to 42 weeks
Part B: Number of Participants with Clinically Significant Change in vital signs
Number of participants with clinically significant change in vital signs (tympanic temperature, pulse rate, respiratory rate, and blood pressure) up to end of intervention period will be assessed.
Measured: Up to 42 weeks
Part B: Number of Participants with Clinically Significant Change in 12-lead Electrocardiogram (ECG) Parameters
Number of participants with clinically significant change in 12-lead ECG parameters will be assessed.
Measured: Up to 42 weeks
Secondary outcomes (9)
Part A: Area Under the Concentration-time Curve to the Last Quantifiable Concentration [AUC(0-t)]
Blood samples were collected at the indicated time points for pharmacokinetic (PK) analysis. PK parameters were calculated by standard non-compartmental analysis.
Measured: Up to 28 weeks
Part A: Area Under the Concentration-time Curve to the Infinity (inf) [AUC(0-inf)]
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
Measured: Up to 28 weeks
Part A: Maximum Concentration (Cmax)
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
Measured: Up to 28 weeks
Part B: Area Under the Concentration-time Curve Over the Dosing Interval [AUC(0-tau)]
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
Measured: Up to 42 weeks
Part B: Cmax
Blood samples were collected at the indicated time points for PK analysis. PK parameters were calculated by standard non-compartmental analysis.
Measured: Up to 42 weeks
Part A: Number of Participants with Anti-Drug Antibodies (ADA) against GSK3682995B
Blood samples were analyzed for the presence of anti-GSK3682995B antibodies by binding ADA assay.
Measured: Up to 28 weeks
Part B: Number of participants with Incidence of Anti-Drug Antibodies (ADA) against GSK3682995B
Blood samples were analyzed for the presence of anti-GSK3682995B antibodies by binding ADA assay.
Measured: Up to 42 weeks
Part A: Ratio to Baseline in Absolute and Relative Blood Eosinophil Count
Ratio to baseline in absolute and relative blood eosinophil count will be assessed.
Measured: Baseline and up to 28 weeks
Part B: Ratio to Baseline in Absolute and Relative Blood Eosinophil Count
Ratio to baseline in absolute and relative blood eosinophil count will be assessed.
Measured: Baseline and up to 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start27 Nov 2023
- Primary completion16 Dec 2026 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Sequential
- Model description
- The primary purpose of the study is to evaluate the safety, and tolerability of GSK3862995B following single dose in healthy participants and repeat doses in participants with Chronic obstructive pulmonary disorder (COPD).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 127 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
- NCT06154837
- Sponsor's protocol ID
- 221531
- Other IDs
- 2023-506880-32, 2023-506880-32-00, 2023-506880-32, 2023
- Status last verified
- Nov 2026
- First submitted
- 26 Nov 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part Phase 1 Randomized, Double-blind, Placebo-controlled Study to Investigate Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of GSK3862995B Following Single Ascending Doses in Healthy Participants and Repeat Doses in Participants With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06154837
- Acronym / sponsor ID
- 221531
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- GSK3862995B, Chronic Obstructive Pulmonary Disease, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 127 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 16 Dec 2026 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to investigate the safety and tolerability of ascending doses of GSK3862995B following single dose in healthy participants and repeat doses in participants with Chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
- Model description
- The primary purpose of the study is to evaluate the safety, and tolerability of GSK3862995B following single dose in healthy participants and repeat doses in participants with Chronic obstructive pulmonary disorder (COPD).
| Arm | Type | Receives |
|---|---|---|
| Part A Dose Level 1: Single dose of GSK3862995B | Experimental | Drug: GSK3862995BHealthy participants will receive single dose of GSK3862995B. |
| Part A Dose Level 2: Single dose of GSK3862995B | Experimental | Drug: GSK3862995BHealthy participants will receive single dose of GSK3862995B. |
| Part A Dose Level 3: Single dose of GSK3862995B | Experimental | Drug: GSK3862995BHealthy participants will receive single dose of GSK3862995B. |
| Part A Dose Level 4: Single dose of GSK3862995B | Experimental | Drug: GSK3862995BHealthy participants will receive single dose of GSK3862995B. |
| Part A Dose Level 5: Single dose of GSK3862995B | Experimental | Drug: GSK3862995BHealthy participants will receive single dose of GSK3862995B. |
| Part A Dose Level 6: Single dose of GSK3862995B | Experimental | Drug: GSK3862995BHealthy participants will receive single dose of GSK3862995B. |
| Part A: Placebo | Placebo comparator | Drug: PlaceboHealthy participants will receive single dose of placebo. |
| Part B: Repeat dose of GSK3862995B | Experimental | Drug: GSK3862995BParticipants with COPD will receive repeat doses of GSK3862995B. |
| Part B: Placebo | Placebo comparator | Drug: PlaceboParticipants with COPD will receive repeat doses of placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Healthy participants (Part A)
- Participant must be 18 to 65 years of age inclusive.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Body weight within the range 50-110 kilogram (kg) (inclusive)
- Body mass index (BMI) within the range 19.5-32 kilogram per square meter (kg/m^2)
Key exclusion criteria (11 listed)
- Participant has a past or current medical condition(s) or disease(s) that is/are not well controlled and, which in the judgement of the Investigator, may affect participant safety or affect study endpoints.
- A history of recurrent infections, or treatment of a chronic infection within 3 months prior to the first dose of study drug, including both serious local infection (for example, cellulitis, abscess) or systemic infection (for example, pneumonia, tuberculosis, hepatitis B, shingles).
- Significant allergies to humanized monoclonal antibodies.
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
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 |
|---|---|---|
| GSK3862995BGSK3862995B will be administered. | Drug | Part A Dose Level 1: Single dose of GSK3862995B, Part A Dose Level 2: Single dose of GSK3862995B, Part A Dose Level 3: Single dose of GSK3862995B, Part A Dose Level 4: Single dose of GSK3862995B, Part A Dose Level 5: Single dose of GSK3862995B, Part A Dose Level 6: Single dose of GSK3862995B, Part B: Repeat dose of GSK3862995B |
| PlaceboPlacebo will be administered. | Drug | Part A: Placebo, Part B: Placebo |
Primary outcome
Part A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 36 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
Part B: Number of Participants with AEs and SAEs
Time frame: Up to 48 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment is categorized as SAE.
Part A: Number of Participants with Clinically significant changes in laboratory values
Time frame: Up to 28 weeks
Number of Participants with clinically significant changes in laboratory values (haematology, chemistry, and urinalysis) will be assessed.
Part A: Number of Participants with Clinically Significant Change in vital signs
Time frame: Up to 28 weeks
Number of participants with clinically significant change in vital signs (tympanic temperature, pulse rate, respiratory rate, and blood pressure) will be assessed.
Part A: Number of Participants with Clinically Significant Change in 12-lead Electrocardiogram (ECG) Parameters
Time frame: Up to 28 weeks
Number of participants with clinically significant change in 12-lead ECG parameters will be assessed.
Part B: Number of Participants with Clinically significant changes in laboratory values (haematology, chemistry and urinalysis)
Time frame: Up to 42 weeks
Number of Participants with clinically significant changes in laboratory values (haematology, chemistry and urinalysis) will be assessed.
Part B: Number of Participants with Clinically Significant Change in vital signs
Time frame: Up to 42 weeks
Number of participants with clinically significant change in vital signs (tympanic temperature, pulse rate, respiratory rate, and blood pressure) up to end of intervention period will be assessed.
Part B: Number of Participants with Clinically Significant Change in 12-lead Electrocardiogram (ECG) Parameters
Time frame: Up to 42 weeks
Number of participants with clinically significant change in 12-lead ECG parameters will be assessed.
9 secondary outcomes
Part A: Area Under the Concentration-time Curve to the Last Quantifiable Concentration [AUC(0-t)]
Time frame: Up to 28 weeks
Part A: Area Under the Concentration-time Curve to the Infinity (inf) [AUC(0-inf)]
Time frame: Up to 28 weeks
Part A: Maximum Concentration (Cmax)
Time frame: Up to 28 weeks
Part B: Area Under the Concentration-time Curve Over the Dosing Interval [AUC(0-tau)]
Time frame: Up to 42 weeks
Part B: Cmax
Time frame: Up to 42 weeks
Part A: Number of Participants with Anti-Drug Antibodies (ADA) against GSK3682995B
Time frame: Up to 28 weeks
Part B: Number of participants with Incidence of Anti-Drug Antibodies (ADA) against GSK3682995B
Time frame: Up to 42 weeks
Part A: Ratio to Baseline in Absolute and Relative Blood Eosinophil Count
Time frame: Baseline and up to 28 weeks
Part B: Ratio to Baseline in Absolute and Relative Blood Eosinophil Count
Time frame: Baseline and up to 42 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
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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
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GSK3862995B in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 31 sites in 3 countries.
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 16 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Germany, United States, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Part A: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 36 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.