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NCT06558097 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of XXB750 in Healthy Participants
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
NCT06558097: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT06558097 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 77 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06558097, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
Study 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)
Primary Outcome
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.
Interventions
- OTHER Placebo
- DRUG XXB750
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 1 |
What the finished NCT06558097 record still lists
NCT06558097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06558097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06558097 about?
NCT06558097 is a clinical study titled "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)
What is the current status of trial NCT06558097?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2020-07-29. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT06558097?
The interventions under investigation include: Placebo (OTHER), XXB750 (DRUG).
Who is sponsoring clinical trial NCT06558097?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06558097's enrollment target sits among peer trials
77 703rd of 2000 higher than 1,296 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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