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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: Completed Phase 1 study, sponsored by Sanofi.
NCT05796479 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Cmax after administration of a single SC dose of amlitelimab DP 1
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 |
What the finished NCT05796479 record still lists
NCT05796479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Amlitelimab DP1 is the first listed.
NCT05796479 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05796479's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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