NCT01448239: Alirocumab single-dose safety and drug exposure

NCT01448239 is a separate early-phase alirocumab study of single-dose safety, tolerability, pharmacokinetics and pharmacodynamics. The registration records 24 actual healthy adult participants and subcutaneous dosing. Regeneron's official trial page confirms the study's identity and these pharmacology objectives. 1 2 3

The relevant information is how exposure and biological measurements were characterized after a single dose, rather than a long-term comparison of cardiovascular events. It should not be merged with the 36-participant formulation study NCT01443650 merely because both concern alirocumab. 2

The inspected protocol provides the population and measurement framework but not a verified numerical exposure ratio, LDL reduction or adverse-event comparison. A later alirocumab outcomes trial would need its own citation and identifier; it cannot supply missing results for these 24 volunteers. 2

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT01448239. Original registration; establishes the exact study identity and registered methods.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT01448239. Original registration; establishes the exact study identity and registered methods.

2. ICH GCP — ICH GCP — NCT01448239. Readable reproduction of the sponsor-submitted registration, including the design and dated status fields; not an independent outcome study.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.

3. Regeneron — Regeneron — NCT01448239, official sponsor page. Confirms this specific single-dose alirocumab pharmacology protocol.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.