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NCT05099133 · ClinicalTrials.gov registry record · Phase 1
A Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects
A Phase 1 study of Atopic Dermatitis, sponsored by LEO Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05099133: Completed Phase 1 study of Atopic Dermatitis, sponsored by LEO Pharma.
NCT05099133 is a Phase 1 study of Atopic Dermatitis that has completed, run by LEO Pharma. The registered enrollment target is 24 participants, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05099133, a Phase 1 study of Atopic Dermatitis, has completed, sponsored by LEO Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This trial will investigate the pharmacokinetics, immunogenicity, safety, and tolerability of LEO 138559 in healthy Japanese subjects. The trial consists of a screening period of up to 4 weeks, a single treatment with either LEO 138559 or placebo, and 8 follow-up visits to Day 85. A total of 24 healthy subjects will be enrolled in 3 dose groups (n=8 per dose group) and randomized to either LEO 138559 or placebo in a ratio of 6:2.
Primary Outcome
Pharmacokinetic endpoint to be determined from serum concentrations
Conditions Studied
Interventions
- DRUG LEO 138559
- DRUG LEO 138559 Placebo
Study Locations (1)
California
- LEO Investigational Site - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-11-03 |
| Est. Completion | 2022-06-28 |
| Phase | Phase 1 |
What the finished NCT05099133 record still lists
NCT05099133 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Atopic Dermatitis appearing as the primary indexed condition, and to 2 interventions - of which LEO 138559 is the first listed.
NCT05099133 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05099133 about?
NCT05099133 is a clinical study titled "A Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects". This trial will investigate the pharmacokinetics, immunogenicity, safety, and tolerability of LEO 138559 in healthy Japanese subjects. The trial consists of a screening period of up to 4 weeks, a single treatment with either LEO 138559 or placebo, and 8 follow-up visits to Day 85. A total of 24 he...
What is the current status of trial NCT05099133?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-11-03. Estimated completion is 2022-06-28.
What conditions does trial NCT05099133 study?
This clinical trial studies the following conditions: Atopic Dermatitis.
What interventions are being tested in trial NCT05099133?
The interventions under investigation include: LEO 138559 (DRUG), LEO 138559 Placebo (DRUG).
Who is sponsoring clinical trial NCT05099133?
This trial is sponsored by LEO Pharma, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05099133 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05099133's enrollment target sits among peer trials
24 129th of 150 higher than 20 of 150 other Atopic Dermatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atopic Dermatitis 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.
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