Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as HJB647 low dose
HJB647 · 2 trials · 3 indications
Cmax: The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)
Tmax: The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)
AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)
AUCinf: The AUC from time zero to infinity (mass x time x volume-1)
T1/2: The elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time). Use qualifier for other half-lives
Number of participants with adverse events (AEs) including abnormal vital signs, ECG, and safety laboratory parameters
Number of participants with AEs as a measure of safety and tolerability
Number of participants with clinically significant changes in Systolic Blood Pressure, Diastolic Blood Pressure, Heart Rate, Electrocardiogram and hyposensitive events as a measure of adverse events
| Arm | Type | Description |
|---|---|---|
| Part 1-1: HJB647 low dose | EXPERIMENTAL | Single dose Day 1 in Part 1 |
| Part 1-2: HJB647 mid-dose | EXPERIMENTAL | Single dose Day 1 in Part 1 |
| Part 1-3: HJB647 high dose | EXPERIMENTAL | Single dose Day 1 in Part 1 |
| Part 1: Placebo | PLACEBO_COMPARATOR | Single dose Day 1 in Part 1 |
| Part 2-1: HJB647 multiple oral doses | EXPERIMENTAL | Multiple oral doses of HJB647 with adaptive up-titration in Part 2 |
| Part 2-2: HJB647 multiple oral doses (optional cohort) | EXPERIMENTAL | Multiple oral doses of HJB647 with adaptive up-titration in Part 2 |
| Part 2-3: HJB647 multiple oral doses (optional cohort) | EXPERIMENTAL | Multiple oral doses of HJB647 with adaptive up-titration in Part 2 |
| Part 2-4: HJB647 multiple oral doses (optional cohort) | EXPERIMENTAL | Multiple oral doses of HJB647 with adaptive up-titration in Part 2 |
| Part 2-5: HJB647 multiple oral doses (optional cohort) | EXPERIMENTAL | Multiple oral doses of HJB647 with adaptive up-titration in Part 2 |
| Part 2: Placebo | PLACEBO_COMPARATOR | Multiple oral doses of placebo with adaptive up-titration in Part 2 |
| Placebo | PLACEBO_COMPARATOR | Taken by mouth as capsules |
| HJB647 low dose | EXPERIMENTAL | Taken by mouth as capsule |
| HJB647 high dose | EXPERIMENTAL | Taken by mouth as capsule |
| Name | Type | Description |
|---|---|---|
| HJB647 | DRUG | HJB647 oral capsule |
| Placebo | DRUG | Matching oral placebo |
| HJB647 low dose | DRUG | Study drug low dose in capsule form |
| HJB647 high dose | DRUG | Study drug high dose in capsule form |
Inclusion Criteria: * Japanese healthy participants with elevated blood pressure (Part 1) and patients with mild-to-moderate hypertension (Part 2) * Age: 18 to 55 years (Part 1) and 18 to 60 years (Part 2) * Body weight: * Male: ≥ 50.0 kg * Female: ≥ 45.0 kg * Body Mass Index (BMI): 18.0 to 30...
HJB647 is an investigational small molecule being developed for cardiovascular conditions, specifically heart failure with reduced ejection fraction and elevated blood pressure. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
HJB647 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting early-stage clinical trials to evaluate the drug's safety and tolerability.
HJB647 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies and is still undergoing early-stage testing in human participants to assess safety, tolerability, and other key parameters.
HJB647 is being studied in two Phase 1 trials. NCT07465653 is evaluating safety and tolerability in heart failure patients with reduced ejection fraction in the United States and Canada. NCT07644364 is a Phase 1b study in Japanese healthy participants and patients with elevated blood pressure or hypertension.
Yes, HJB647 is also known as HJB647 low dose. This alternative name may be used in certain contexts to distinguish the specific dosing regimen being evaluated in clinical studies.