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NCT05796479 · ClinicalTrials.gov registry record · Phase 1
A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT05796479 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 32 participants.
The verdict
NCT05796479, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This is a 2-part, Phase 1 study, with 1 arm in Part 1 and a randomized parallel design in Part 2. The purpose of this study is to evaluate the comparability of pharmacokinetics, safety and tolerability of two different amlitelimab drug products (DPs) after administration of a single subcutaneus (SC) dose in healthy adult participants. Study details include: The study duration for a participant will be approximately 17 weeks. The study includes a screening period of up to 28 days, a 4-day institutionalization period, and a follow up period for approximately 89 days (9 visits).
Interventions
- DRUG Amlitelimab DP1
- DRUG Amlitelimab DP2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2022-04-28 |
| Est. Completion | 2023-05-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05796479
The ClinicalTrials.gov registry entry for NCT05796479 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Amlitelimab DP1 is the first listed.
NCT05796479 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05796479 about?
NCT05796479 is a clinical study titled "A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants". This is a 2-part, Phase 1 study, with 1 arm in Part 1 and a randomized parallel design in Part 2. The purpose of this study is to evaluate the comparability of pharmacokinetics, safety and tolerability of two different amlitelimab drug products (DPs) after administration of a single subcutaneus (SC)...
What is the current status of trial NCT05796479?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2022-04-28. Estimated completion is 2023-05-22.
What interventions are being tested in trial NCT05796479?
The interventions under investigation include: Amlitelimab DP1 (DRUG), Amlitelimab DP2 (DRUG).
Who is sponsoring clinical trial NCT05796479?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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