Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Sanofi.
NCT06114238 is a Phase 1 study that has completed, run by Sanofi. The registered enrollment target is 90 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher). According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
Maximum plasma concentration of itepekimab
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 |
What the finished NCT06114238 record still lists
NCT06114238 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% higher).
The record links to 0 conditions, and to 2 interventions - of which Itepekimab AI is the first listed.
NCT06114238 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06114238's enrollment target sits among peer trials
90 628th of 2000 higher than 1,352 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02521311 · 90 participants · Phase 2
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
- NCT02939573 · 90 participants · Phase 2
A Randomized Multicenter Study for Isolated Skin Vasculitis
- NCT03128879 · 90 participants · Phase 2
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
- NCT03184038 · 90 participants · NA
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI