Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06979518 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of GSK3862995B Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and European Ancestry | PHASE1 | NOT YET_RECRUITING | 30 | — | — | May 20, 2025 | Apr 27, 2026 | May 20, 2025 | - | — |
| NCT06154837 | A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease | PHASE1 | ACTIVE NOT_RECRUITING | 127 | — | — | Nov 27, 2023 | Dec 17, 2026 | May 29, 2026 | 32 | United States, Germany +1 |
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, meets one or more of the criteria: 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 in the offspring of a study participant, or abnormal pregnancy outcomes (such as, spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy).
Number of Participants with clinically significant changes in clinical laboratory values (hematology, chemistry and urinalysis) will be assessed.
Number of Participants with clinically significant changes in vital signs will be assessed.
Number of Participants with clinically significant changes in 12-lead ECG will be assessed.
Blood samples will be collected to determine the pharmacokinetic profile of GSK3862995B.
Blood samples will be collected to determine the pharmacokinetic profile of GSK3862995B.
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.
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.
Number of Participants with clinically significant changes in laboratory values (haematology, chemistry, and urinalysis) will be assessed.
Number of participants with clinically significant change in vital signs (tympanic temperature, pulse rate, respiratory rate, and blood pressure) will be assessed.
Number of participants with clinically significant change in 12-lead ECG parameters will be assessed.
Number of Participants with clinically significant changes in laboratory values (haematology, chemistry and urinalysis) will be assessed.
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.
Number of participants with clinically significant change in 12-lead ECG parameters will be assessed.
| Arm | Type | Description |
|---|---|---|
| GSK3862995B | EXPERIMENTAL | Participants of Chinese, Japanese, or European ancestries will receive GSK3862995B. |
| Placebo | EXPERIMENTAL | Participants of Chinese, Japanese, or European ancestries will receive matching placebo. |
| Part A Dose Level 1: Single dose of GSK3862995B | EXPERIMENTAL | Healthy participants will receive single dose of GSK3862995B. |
| Part A Dose Level 2: Single dose of GSK3862995B | EXPERIMENTAL | Healthy participants will receive single dose of GSK3862995B. |
| Part A Dose Level 3: Single dose of GSK3862995B | EXPERIMENTAL | Healthy participants will receive single dose of GSK3862995B. |
| Part A Dose Level 4: Single dose of GSK3862995B | EXPERIMENTAL | Healthy participants will receive single dose of GSK3862995B. |
| Part A Dose Level 5: Single dose of GSK3862995B | EXPERIMENTAL | Healthy participants will receive single dose of GSK3862995B. |
| Part A Dose Level 6: Single dose of GSK3862995B | EXPERIMENTAL | Healthy participants will receive single dose of GSK3862995B. |
| Part A: Placebo | PLACEBO_COMPARATOR | Healthy participants will receive single dose of placebo. |
| Part B: Repeat dose of GSK3862995B | EXPERIMENTAL | Participants with COPD will receive repeat doses of GSK3862995B. |
| Part B: Placebo | PLACEBO_COMPARATOR | Participants with COPD will receive repeat doses of placebo. |
| Name | Type | Description |
|---|---|---|
| GSK3862995B | DRUG | GSK3862995B will be administered. |
| Placebo | DRUG | Matching placebo will be administered. |
Inclusion Criteria: * Participant must be 18 to 50 years of age inclusive * Participants who are generally healthy as determined by medical evaluation based on screening medical history, physical examination, laboratory tests, and cardiac monitoring * Body weight of at least 50.0 kilogram (kg) for ...