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NCT06114238 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe
A Phase 1 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 1
- Development phase
- 90
- Enrollment target
NCT06114238 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 90 participants.
The verdict
NCT06114238, a Phase 1 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 90 participants
- Enrollment target
Study Summary
This Phase 1, single-center study will be conducted in an open-label, randomized, parallel design. Healthy male and female participants aged 18 to 65 years will receive a single dose of itepekimab subcutaneous (SC) administered by either a prefilled syringe (PFS) or an autoinjector (AI). Itepekimab will be administered by a trained healthcare professional (HCP). Female and male participants will have a body weight between 50.0 and 100.0 kg and body mass index (BMI) \>18.5 and ≤30 kg/m2. Participants who satisfy the inclusion criteria will be randomized to one of the 2 study intervention groups: * Itepekimab administered via AI (test) * Itepekimab administered via PFS (reference) The randomization will be stratified by weight category (\<70 kg, ≥70 to \<80 kg and ≥80 kg) and injection site (abdomen, thigh, and arm). Study duration for each participant is up to approximately 162 days, including: * Screening period: up to 21 days * Institutionalization: 2 days including 1 treatment day (Day 1) * Follow-up period: 140 days (±5 days) * End of study (EOS): Day 141 (± 5 days)
Interventions
- DRUG Itepekimab AI
- DRUG Itepekimab PFS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2021-09-16 |
| Est. Completion | 2022-03-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06114238
The ClinicalTrials.gov registry entry for NCT06114238 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 90 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 Itepekimab AI is the first listed.
NCT06114238 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06114238 about?
NCT06114238 is a clinical study titled "Pharmacokinetic Study to Compare Itepekimab Exposure When Administered With an Autoinjector Versus Prefilled Syringe". This Phase 1, single-center study will be conducted in an open-label, randomized, parallel design. Healthy male and female participants aged 18 to 65 years will receive a single dose of itepekimab subcutaneous (SC) administered by either a prefilled syringe (PFS) or an autoinjector (AI). Itepekimab ...
What is the current status of trial NCT06114238?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 90 participants. The study started on 2021-09-16. Estimated completion is 2022-03-08.
What interventions are being tested in trial NCT06114238?
The interventions under investigation include: Itepekimab AI (DRUG), Itepekimab PFS (DRUG).
Who is sponsoring clinical trial NCT06114238?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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