XXB750 in Healthy ParticipantsPhase 1NCT06558097
Safety, Tolerability, and Pharmacokinetics of XXB750 in Healthy Participants
A Phase 1 study testing XXB750 in people with XXB750 in Healthy Participants, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study was a randomized, participant and investigator-blinded, placebo-controlled, single-ascending dose study, consisting of 9 sequential dose cohorts (1 mg, 3 mg, 10 mg, 30 mg, 60 mg, 120 mg, 240 mg, 450 mg and 600 mg) and a Japanese ethnic sensitivity cohort (240 mg dose) Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- XXB750 in Healthy Participants
- What is being tested?
- XXB750
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2020to 31 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female participants age 18 to 50 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 32 kg/m2. BMI = Body weight (kg) / [Height (m)]2
- For ethnic Japanese cohort: participants must be defined as being of first, second or third generation ethnic origin, with each set of parents qualifying as Japanese under the prior generation.
Who cannot join
- Any surgical or medical condition which significantly altered the distribution, metabolism, or excretion of drugs, or which jeopardized the participant's participation in the study.
- Known history or current clinically significant arrhythmias.
- Women of child-bearing potential were excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
Cypress, California, 90630
About this study
Official title: A First-in-human, Randomized, Sponsor Open-label, Participant and Investigator Blinded, Placebo-controlled, Single Ascending Dose Study to Explore the Safety, Tolerability and Pharmacokinetics of XXB750 in Healthy Participants
This study was a randomized, participant and investigator-blinded, placebo-controlled, single-ascending dose study, consisting of 9 sequential dose cohorts (1 mg, 3 mg, 10 mg, 30 mg, 60 mg, 120 mg, 240 mg, 450 mg and 600 mg) and a Japanese ethnic sensitivity cohort (240 mg dose)
Read the detailed description
Eligible healthy participants with normal blood pressure (SBP: 110-139 mmHg; DBP: 70-89 mmHg) were randomized into dose cohorts 1 - 240 mg. Eligible healthy participants with elevated blood pressure (SBP: 139 - 159 mmHg; DBP: 75 - 95 mmHg) were randomized into dose cohorts 450 and 600 mg. Each participant received a subcutaneous single dose of either XXB750 or placebo. In total, the duration of the study was 151 days, including the full Screening period of up to 28 days, safety, pharmacokinetics and pharmacodynamics assessments over a period of 91 days, and a 30-day safety follow up call after the end of study visit.
Sentinel dosing will be applied in this FIH study at each new dose level to ensure participant's safety and minimize the number of participants that may experience symptomatic hypotension, especially for sustained periods of time attributing to the long acting nature of XXB750 and the sustained pharmacological effects on BP at higher doses. The 10-day safety monitoring for the sentinel cohort is considered sufficient based on the predicted mean Tmax (4.5 days) in humans.
- Conditions
- XXB750 in Healthy Participants
- Being tested
- XXB750, Placebo
- Keywords
- XXB750, healthy participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XXB750Drug
Single SC dose of XXB750 (administered by single or multiple injections)
PlaceboOther
Single SC dose of matching placebo (administered by single or multiple injections)
| Study group | Role | What they receive |
|---|---|---|
| XXB750 s.c 1 mg | Experimental | Single SC dose of XXB750 1 mg Receives: Drug: XXB750 |
| XXB750 s.c 3 mg | Experimental | Single SC dose of XXB750 3 mg Receives: Drug: XXB750 |
| XXB750 s.c 10 mg | Experimental | Single SC dose of XXB750 10 mg Receives: Drug: XXB750 |
| XXB750 s.c 30 mg | Experimental | Single SC dose of XXB750 30 mg Receives: Drug: XXB750 |
| XXB750 s.c 60 mg | Experimental | Single SC dose of XXB750 60 mg Receives: Drug: XXB750 |
| XXB750 s.c 120 mg | Experimental | Single SC dose of XXB750 120 mg Receives: Drug: XXB750 |
| XXB750 s.c 240 mg | Experimental | Single SC dose of XXB750 240 mg Receives: Drug: XXB750 |
| Placebo | Placebo comparator | Placebo to XXB750 Receives: Other: Placebo |
| XXB750 s.c 240 mg Japanese cohort | Experimental | Single SC dose of XXB750 240 mg in the Japanese cohort Receives: Drug: XXB750 |
| Placebo for Japanese cohort | Placebo comparator | Placebo to XXB750 in the Japanese cohort Receives: Other: Placebo |
| XXB750 s.c 450 mg (HBP) | Experimental | Single SC dose of XXB750 450 mg (High Blood Pressure Cohort) Receives: Drug: XXB750 |
| XXB750 s.c 600 mg (HBP) | Experimental | Single SC dose of XXB750 600 mg (High Blood Pressure Cohort) Receives: Drug: XXB750 |
| Placebo to High Blood Pressure cohort | Placebo comparator | Placebo to XXB750 in High Blood Pressure cohorts 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
To evaluate the safety and tolerability of single ascending SC doses of XXB750 in healthy participants.
Adverse events may include abnormal vital signs, safety laboratory tests, physical exam tests and ECG parameters that include clinical signs or symptoms, are considered clinically significant or require therapy.
Measured: Up to 121 days
Secondary outcomes (7)
Pharmacokinetics parameters: Tmax
To evaluate the pharmacokinetics: Time to maximum concentation (Tmax) of XXB750 in healthy participants following a single SC dose of XXB750.
Measured: Up to 91 days
Pharmacokinetics parameters: Cmax
To evaluate the pharmacokinetics: Peak plasma concentration (Cmax) of XXB750 in healthy participants following a single SC dose of XXB750.
Measured: Up to 91 days
Pharmacokinetics parameters: AUClast
To evaluate the pharmacokinetics: Area under the plasma concentration curve (AUClast) of XXB750 in healthy participants following a single SC dose of XXB750.
Measured: Up to 91 days
Pharmacokinetics parameters: AUCinf
To evaluate the pharmacokinetics: Area under the curve (AUCinf) of XXB750 in healthy participants following a single SC dose of XXB750.
Measured: Up to 91 days
Pharmacokinetics parameters: T1/2
To evaluate the pharmacokinetics: Half-life (T1/2) of XXB750 in healthy participants following a single SC dose of XXB750.
Measured: Up to 91 days
Pharmacokinetics parameters: Vz/F
To evaluate the pharmacokinetics: Vd/F of XXB750 in healthy participants following a single SC dose of XXB750.
Measured: Up to 91 days
Pharmacokinetics parameters: CL/F
To evaluate the pharmacokinetics: Apparent clearance (CL/F) of XXB750 in healthy participants following a single SC dose of XXB750.
Measured: Up to 91 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start29 Jul 2020
- Primary completion2 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for XXB750 in Healthy ParticipantsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 77 participants (actual)
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
- NCT06558097
- Sponsor's protocol ID
- CXXB750A02101
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Randomized, Sponsor Open-label, Participant and Investigator Blinded, Placebo-controlled, Single Ascending Dose Study to Explore the Safety, Tolerability and Pharmacokinetics of XXB750 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06558097
- Acronym / sponsor ID
- CXXB750A02101
- Conditions
- XXB750 in Healthy Participants
- Keywords
- XXB750, healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 16 Aug 2024 (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.
This study was a randomized, participant and investigator-blinded, placebo-controlled, single-ascending dose study, consisting of 9 sequential dose cohorts (1 mg, 3 mg, 10 mg, 30 mg, 60 mg, 120 mg, 240 mg, 450 mg and 600 mg) and a Japanese ethnic sensitivity cohort (240 mg dose)
Detailed description
Eligible healthy participants with normal blood pressure (SBP: 110-139 mmHg; DBP: 70-89 mmHg) were randomized into dose cohorts 1 - 240 mg. Eligible healthy participants with elevated blood pressure (SBP: 139 - 159 mmHg; DBP: 75 - 95 mmHg) were randomized into dose cohorts 450 and 600 mg. Each participant received a subcutaneous single dose of either XXB750 or placebo. In total, the duration of the study was 151 days, including the full Screening period of up to 28 days, safety, pharmacokinetics and pharmacodynamics assessments over a period of 91 days, and a 30-day safety follow up call after the end of study visit.
Sentinel dosing will be applied in this FIH study at each new dose level to ensure participant's safety and minimize the number of participants that may experience symptomatic hypotension, especially for sustained periods of time attributing to the long acting nature of XXB750 and the sustained pharmacological effects on BP at higher doses. The 10-day safety monitoring for the sentinel cohort is considered sufficient based on the predicted mean Tmax (4.5 days) in humans.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| XXB750 s.c 1 mg | Experimental | Drug: XXB750Single SC dose of XXB750 1 mg |
| XXB750 s.c 3 mg | Experimental | Drug: XXB750Single SC dose of XXB750 3 mg |
| XXB750 s.c 10 mg | Experimental | Drug: XXB750Single SC dose of XXB750 10 mg |
| XXB750 s.c 30 mg | Experimental | Drug: XXB750Single SC dose of XXB750 30 mg |
| XXB750 s.c 60 mg | Experimental | Drug: XXB750Single SC dose of XXB750 60 mg |
| XXB750 s.c 120 mg | Experimental | Drug: XXB750Single SC dose of XXB750 120 mg |
| XXB750 s.c 240 mg | Experimental | Drug: XXB750Single SC dose of XXB750 240 mg |
| Placebo | Placebo comparator | Other: PlaceboPlacebo to XXB750 |
| XXB750 s.c 240 mg Japanese cohort | Experimental | Drug: XXB750Single SC dose of XXB750 240 mg in the Japanese cohort |
| Placebo for Japanese cohort | Placebo comparator | Other: PlaceboPlacebo to XXB750 in the Japanese cohort |
| XXB750 s.c 450 mg (HBP) | Experimental | Drug: XXB750Single SC dose of XXB750 450 mg (High Blood Pressure Cohort) |
| XXB750 s.c 600 mg (HBP) | Experimental | Drug: XXB750Single SC dose of XXB750 600 mg (High Blood Pressure Cohort) |
| Placebo to High Blood Pressure cohort | Placebo comparator | Other: PlaceboPlacebo to XXB750 in High Blood Pressure cohorts |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female participants age 18 to 50 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 32 kg/m2. BMI = Body weight (kg) / [Height (m)]2
- For ethnic Japanese cohort: participants must be defined as being of first, second or third generation ethnic origin, with each set of parents qualifying as Japanese under the prior generation.
Key exclusion criteria (3 listed)
- Any surgical or medical condition which significantly altered the distribution, metabolism, or excretion of drugs, or which jeopardized the participant's participation in the study.
- Known history or current clinically significant arrhythmias.
- Women of child-bearing potential were excluded from this study.
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 |
|---|---|---|
| XXB750Single SC dose of XXB750 (administered by single or multiple injections) | Drug | XXB750 s.c 1 mg, XXB750 s.c 10 mg, XXB750 s.c 120 mg, XXB750 s.c 240 mg, XXB750 s.c 240 mg Japanese cohort, XXB750 s.c 3 mg, XXB750 s.c 30 mg, XXB750 s.c 450 mg (HBP), XXB750 s.c 60 mg, XXB750 s.c 600 mg (HBP) |
| PlaceboSingle SC dose of matching placebo (administered by single or multiple injections) | Other | Placebo, Placebo for Japanese cohort, Placebo to High Blood Pressure cohort |
Primary outcome
Number of participants with Adverse Events
Time frame: Up to 121 days
To evaluate the safety and tolerability of single ascending SC doses of XXB750 in healthy participants. Adverse events may include abnormal vital signs, safety laboratory tests, physical exam tests and ECG parameters that include clinical signs or symptoms, are considered clinically significant or require therapy.
7 secondary outcomes
Pharmacokinetics parameters: Tmax
Time frame: Up to 91 days
Pharmacokinetics parameters: Cmax
Time frame: Up to 91 days
Pharmacokinetics parameters: AUClast
Time frame: Up to 91 days
Pharmacokinetics parameters: AUCinf
Time frame: Up to 91 days
Pharmacokinetics parameters: T1/2
Time frame: Up to 91 days
Pharmacokinetics parameters: Vz/F
Time frame: Up to 91 days
Pharmacokinetics parameters: CL/F
Time frame: Up to 91 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: No
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.
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 XXB750 in people with XXB750 in Healthy Participants, run by Novartis Pharmaceuticals 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 3 inclusion and 3 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 16 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Up to 121 days). 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 16 Aug 2024.