Elevated Blood PressurePhase 1NCT07644364
HJB647 Phase 1b Study in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension
A Phase 1 study testing HJB647 in people with Elevated Blood Pressure and Hypertension, run by Novartis Pharmaceuticals at 1 site in Japan.
Trial summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacokinetics, and pharmacodynamics of HJB647 following single dose administration in Japanese healthy participants with elevated blood pressure and multiple dose administration with up titration in Japanese patients with… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Elevated Blood Pressure, Hypertension
- What is being tested?
- HJB647
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteJapan
- Study dates
- 2 Jul 2026to 25 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 30.0 kg/m²
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- Axillary body temperature: 35.0-37.5 °C
- Heart rate: 50-90 bpm
- Blood pressure criteria are as follows:
- Part 1: Healthy Participants with Elevated Blood Pressure Screening: Systolic Blood Pressure (SBP): 120 ≤ SBP ≤ 139 mmHg; Diastolic Blood Pressure (DBP): 60 ≤ DBP ≤ 94 mmHg Baseline (Day -1): SBP: 120 ≤ SBP ≤ 179 mmHg; DBP: 60 ≤ DBP ≤ 109 mmHg
- Part 2: Patients with Hypertension Screening and Baseline (Day -1): SBP: 140 ≤ SBP ≤ 179 mmHg; DBP: 60 ≤ DBP ≤ 109 mmHg
Who cannot join
- Significant illness, including infectious diseases that have not resolved within 30 days prior to baseline
- History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants such as:
- Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker.
- History of familial long QT syndrome or known family history of Torsades de Pointes
- Resting QT interval corrected by Fridericia's formula (QTcF) ≥ 450 msec (male) or ≥ 460 msec (female) at screening
- At screening, hypokalemia or hypomagnesemia defined as potassium or magnesium values below the LLN on repeat measurement, or laboratory abnormalities indicating hypothyroidism, as determined at the discretion of the investigator
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- HbA1c ≥ 7.0% or LDL cholesterol ≥ 180 mg/dL or triglycerides ≥ 250 mg/dL
- Use of any prescription drugs or herbal supplements within 4 weeks prior to initial dosing, and/or OTC medication or dietary supplements (vitamins included) within 2 weeks prior to initial dosing
- Women of childbearing potential
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
Japan1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Sumida Ku, Tokyo, 1300004
About this study
Official title: A Phase 1b, Randomized, Participant- and Investigator- Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HJB647 Following Single Ascending Dose and Up-titration Multiple Dose Administration in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacokinetics, and pharmacodynamics of HJB647 following single dose administration in Japanese healthy participants with elevated blood pressure and multiple dose administration with up titration in Japanese patients with hypertension, to support future clinical development of HJB647
Read the detailed description
Randomized, placebo-controlled, participant- and investigator-blind study consisting of two parts:
- Part 1 (SAD part): Single oral dose in healthy participants. Sentinel dosing will be applied in each cohort.
- Part 2 (MAD part): Multiple oral doses in patients with hypertension. Safety reviews will guide dose escalation and up-titration.
- Conditions
- Elevated Blood Pressure, Hypertension
- Being tested
- HJB647, Placebo
- Keywords
- HJB647, safety, tolerability, pharmacokinetics, Japanese participants with elevated blood pressure, Japanese patients with hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HJB647Drug
HJB647 oral capsule
PlaceboDrug
Matching oral placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1-1: HJB647 low dose | Experimental | Single dose Day 1 in Part 1 Receives: Drug: HJB647 |
| Part 1-2: HJB647 mid-dose | Experimental | Single dose Day 1 in Part 1 Receives: Drug: HJB647 |
| Part 1-3: HJB647 high dose | Experimental | Single dose Day 1 in Part 1 Receives: Drug: HJB647 |
| Part 1: Placebo | Placebo comparator | Single dose Day 1 in Part 1 Receives: Drug: Placebo |
| Part 2-1: HJB647 multiple oral doses | Experimental | Multiple oral doses of HJB647 with adaptive up-titration in Part 2 Receives: Drug: HJB647 |
| Part 2-2: HJB647 multiple oral doses (optional cohort) | Experimental | Multiple oral doses of HJB647 with adaptive up-titration in Part 2 Receives: Drug: HJB647 |
| Part 2-3: HJB647 multiple oral doses (optional cohort) | Experimental | Multiple oral doses of HJB647 with adaptive up-titration in Part 2 Receives: Drug: HJB647 |
| Part 2-4: HJB647 multiple oral doses (optional cohort) | Experimental | Multiple oral doses of HJB647 with adaptive up-titration in Part 2 Receives: Drug: HJB647 |
| Part 2-5: HJB647 multiple oral doses (optional cohort) | Experimental | Multiple oral doses of HJB647 with adaptive up-titration in Part 2 Receives: Drug: HJB647 |
| Part 2: Placebo | Placebo comparator | Multiple oral doses of placebo with adaptive up-titration in Part 2 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Cmax
Cmax: The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)
Measured: Part 1 on Day 1
Part 1: Tmax
Tmax: The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)
Measured: Part 1 on Day 1
Part 1: AUClast
AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)
Measured: Part 1 on Day 1
Part 1: AUCinf
AUCinf: The AUC from time zero to infinity (mass x time x volume-1)
Measured: Part 1 on Day 1
Part 1: T1/2
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
Measured: Part 1 on Day 1
Part 2: Number of participants with AEs
Number of participants with adverse events (AEs) including abnormal vital signs, ECG, and safety laboratory parameters
Measured: Up to 51 days
Secondary outcomes (9)
Part 1: Number of participants with AEs
Number of participants with adverse events (AEs) including abnormal vital signs, ECG, and safety laboratory parameters
Measured: Up to 31 days
Part 2: Cmax
Cmax: The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)
Measured: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: Tmax
Tmax: The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)
Measured: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: AUClast
AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)
Measured: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: AUCinf
AUCinf: The AUC from time zero to infinity (mass x time x volume-1)
Measured: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: AUCtau
AUCtau: The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1)
Measured: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: T1/2
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
Measured: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: Office blood pressure change from baseline
Change in office blood pressure from baseline
Measured: Baseline to Day 27 of part 2
Part 2: Heart rate change from baseline
Change in heart rate from baseline
Measured: Baseline to Day 27 of part 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start2 Jul 2026
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood PressureStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644364
- Sponsor's protocol ID
- CHJB647A11101
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomized, Participant- and Investigator- Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HJB647 Following Single Ascending Dose and Up-titration Multiple Dose Administration in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension
- ClinicalTrials.gov ID
- NCT07644364
- Acronym / sponsor ID
- CHJB647A11101
- Conditions
- Elevated Blood Pressure, Hypertension
- Keywords
- HJB647, safety, tolerability, pharmacokinetics, Japanese participants with elevated blood pressure, Japanese patients with hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 12 Jun 2026 (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 purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacokinetics, and pharmacodynamics of HJB647 following single dose administration in Japanese healthy participants with elevated blood pressure and multiple dose administration with up titration in Japanese patients with hypertension, to support future clinical development of HJB647
Detailed description
Randomized, placebo-controlled, participant- and investigator-blind study consisting of two parts:
- Part 1 (SAD part): Single oral dose in healthy participants. Sentinel dosing will be applied in each cohort.
- Part 2 (MAD part): Multiple oral doses in patients with hypertension. Safety reviews will guide dose escalation and up-titration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part 1-1: HJB647 low dose | Experimental | Drug: HJB647Single dose Day 1 in Part 1 |
| Part 1-2: HJB647 mid-dose | Experimental | Drug: HJB647Single dose Day 1 in Part 1 |
| Part 1-3: HJB647 high dose | Experimental | Drug: HJB647Single dose Day 1 in Part 1 |
| Part 1: Placebo | Placebo comparator | Drug: PlaceboSingle dose Day 1 in Part 1 |
| Part 2-1: HJB647 multiple oral doses | Experimental | Drug: HJB647Multiple oral doses of HJB647 with adaptive up-titration in Part 2 |
| Part 2-2: HJB647 multiple oral doses (optional cohort) | Experimental | Drug: HJB647Multiple oral doses of HJB647 with adaptive up-titration in Part 2 |
| Part 2-3: HJB647 multiple oral doses (optional cohort) | Experimental | Drug: HJB647Multiple oral doses of HJB647 with adaptive up-titration in Part 2 |
| Part 2-4: HJB647 multiple oral doses (optional cohort) | Experimental | Drug: HJB647Multiple oral doses of HJB647 with adaptive up-titration in Part 2 |
| Part 2-5: HJB647 multiple oral doses (optional cohort) | Experimental | Drug: HJB647Multiple oral doses of HJB647 with adaptive up-titration in Part 2 |
| Part 2: Placebo | Placebo comparator | Drug: PlaceboMultiple oral doses of placebo with adaptive up-titration in Part 2 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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:
- Body Mass Index (BMI): 18.0 to 30.0 kg/m²
- Axillary body temperature: 35.0-37.5 °C
Key exclusion criteria (10 listed)
- Significant illness, including infectious diseases that have not resolved within 30 days prior to baseline
- History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants such as:
- At screening, hypokalemia or hypomagnesemia defined as potassium or magnesium values below the LLN on repeat measurement, or laboratory abnormalities indicating hypothyroidism, as determined at the discretion of the investigator
- HbA1c ≥ 7.0% or LDL cholesterol ≥ 180 mg/dL or triglycerides ≥ 250 mg/dL
- Use of any prescription drugs or herbal supplements within 4 weeks prior to initial dosing, and/or OTC medication or dietary supplements (vitamins included) within 2 weeks prior to initial dosing
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 |
|---|---|---|
| HJB647HJB647 oral capsule | Drug | Part 1-1: HJB647 low dose, Part 1-2: HJB647 mid-dose, Part 1-3: HJB647 high dose, Part 2-1: HJB647 multiple oral doses, Part 2-2: HJB647 multiple oral doses (optional cohort), Part 2-3: HJB647 multiple oral doses (optional cohort), Part 2-4: HJB647 multiple oral doses (optional cohort), Part 2-5: HJB647 multiple oral doses (optional cohort) |
| PlaceboMatching oral placebo | Drug | Part 1: Placebo, Part 2: Placebo |
Primary outcome
Part 1: Cmax
Time frame: Part 1 on Day 1
Cmax: The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)
Part 1: Tmax
Time frame: Part 1 on Day 1
Tmax: The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)
Part 1: AUClast
Time frame: Part 1 on Day 1
AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)
Part 1: AUCinf
Time frame: Part 1 on Day 1
AUCinf: The AUC from time zero to infinity (mass x time x volume-1)
Part 1: T1/2
Time frame: Part 1 on Day 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
Part 2: Number of participants with AEs
Time frame: Up to 51 days
Number of participants with adverse events (AEs) including abnormal vital signs, ECG, and safety laboratory parameters
9 secondary outcomes
Part 1: Number of participants with AEs
Time frame: Up to 31 days
Part 2: Cmax
Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: Tmax
Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: AUClast
Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: AUCinf
Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: AUCtau
Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: T1/2
Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: Office blood pressure change from baseline
Time frame: Baseline to Day 27 of part 2
Part 2: Heart rate change from baseline
Time frame: Baseline to Day 27 of part 2
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 22 Jul 2026.
- Individual participant dataSharing planned: No. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 HJB647 in people with Elevated Blood Pressure and Hypertension, run by Novartis Pharmaceuticals at 1 site in Japan.
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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. 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 Japan. 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?
Contact Novartis Pharmaceuticals (+81337978748, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Cmax (time frame: Part 1 on Day 1). 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?
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 22 Jul 2026.