A Phase 1 interventional study of XXB750 and Placebo in XXB750 in Healthy Participants, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-16.
Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Other
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)
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.
Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single SC dose of XXB750 1 mg
Drug: XXB750
Single SC dose of XXB750 3 mg
Drug: XXB750
Single SC dose of XXB750 10 mg
Drug: XXB750
Single SC dose of XXB750 30 mg
Drug: XXB750
Single SC dose of XXB750 60 mg
Drug: XXB750
Single SC dose of XXB750 120 mg
Drug: XXB750
Single SC dose of XXB750 240 mg
Drug: XXB750
Placebo to XXB750
Other: Placebo
Single SC dose of XXB750 240 mg in the Japanese cohort
Drug: XXB750
Placebo to XXB750 in the Japanese cohort
Other: Placebo
Single SC dose of XXB750 450 mg (High Blood Pressure Cohort)
Drug: XXB750
Single SC dose of XXB750 600 mg (High Blood Pressure Cohort)
Drug: XXB750
Placebo to XXB750 in High Blood Pressure cohorts
Other: Placebo
Single SC dose of XXB750 (administered by single or multiple injections)
Single SC dose of matching placebo (administered by single or multiple injections)
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.
Time frame: Up to 121 days
Pharmacokinetics parameters: Tmax
To evaluate the pharmacokinetics: Time to maximum concentation (Tmax) of XXB750 in healthy participants following a single SC dose of XXB750.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 91 days
Plan to share: No
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals