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Safety, Tolerability, and Pharmacokinetics of XXB750 in Healthy Participants

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 121 days

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)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 121 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 121 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with Adverse Events
Secondary study objectives
Pharmacokinetics parameters: AUCinf
Pharmacokinetics parameters: AUClast
Pharmacokinetics parameters: CL/F
+4 more

Trial Design

13Treatment groups
Experimental Treatment
Placebo Group
Group I: XXB750 s.c 600 mg (HBP)Experimental Treatment1 Intervention
Single SC dose of XXB750 600 mg (High Blood Pressure Cohort)
Group II: XXB750 s.c 60 mgExperimental Treatment1 Intervention
Single SC dose of XXB750 60 mg
Group III: XXB750 s.c 450 mg (HBP)Experimental Treatment1 Intervention
Single SC dose of XXB750 450 mg (High Blood Pressure Cohort)
Group IV: XXB750 s.c 30 mgExperimental Treatment1 Intervention
Single SC dose of XXB750 30 mg
Group V: XXB750 s.c 3 mgExperimental Treatment1 Intervention
Single SC dose of XXB750 3 mg
Group VI: XXB750 s.c 240 mg Japanese cohortExperimental Treatment1 Intervention
Single SC dose of XXB750 240 mg in the Japanese cohort
Group VII: XXB750 s.c 240 mgExperimental Treatment1 Intervention
Single SC dose of XXB750 240 mg
Group VIII: XXB750 s.c 120 mgExperimental Treatment1 Intervention
Single SC dose of XXB750 120 mg
Group IX: XXB750 s.c 10 mgExperimental Treatment1 Intervention
Single SC dose of XXB750 10 mg
Group X: XXB750 s.c 1 mgExperimental Treatment1 Intervention
Single SC dose of XXB750 1 mg
Group XI: Placebo for Japanese cohortPlacebo Group1 Intervention
Placebo to XXB750 in the Japanese cohort
Group XII: PlaceboPlacebo Group1 Intervention
Placebo to XXB750
Group XIII: Placebo to High Blood Pressure cohortPlacebo Group1 Intervention
Placebo to XXB750 in High Blood Pressure cohorts
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XXB750
2022
Completed Phase 1
~110

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,918 Previous Clinical Trials
4,254,246 Total Patients Enrolled
~14 spots leftby Dec 2025
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