Safety, Tolerability, and Pharmacokinetics of XXB750 in Healthy Participants

Completed · Phase 1 · Has a placebo group

Conditions studied: XXB750 in Healthy Participants

In brief

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)

Key facts

Study ID

NCT06558097

Run by

Novartis Pharmaceuticals

People needed

77

Starts

2020-07-29

Expected to finish

2023-03-31

Last updated by the study team

2024-08-16

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Cypress, California, United States

Full record on ClinicalTrials.gov

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