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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05099133
The ClinicalTrials.gov registry entry for NCT05099133 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 609-participant average among 150 other Atopic Dermatitis trials with a reported enrollment target (96% lower). The listed sponsor is LEO Pharma, which has 65 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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