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NCT02601625 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects

A Phase 1 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target

NCT02601625: Completed Phase 1 study, sponsored by AstraZeneca.

NCT02601625 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02601625, a Phase 1 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

This is a Phase I, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Pharmacokinetics and Safety of anifrolumab following Single-Dose administration to healthy subjects

Primary Outcome

To evaluate Cmax of anifrolumab after single administration of two doses subcutaneously and one dose intravenously. Up to 13 blood samples were collected in total.

Interventions

  • DRUG Anifrolumab SC injection (300mg)
  • DRUG Anifrolumab IV infusion (300mg)
  • DRUG Anifrolumab SC infusion (600mg)
  • DRUG Anifrolumab placebo SC injection (300mg)
  • DRUG Anifrolumab placebo IV infusion (300mg)

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2015-11-16
Est. Completion 2016-05-25
Phase Phase 1
AstraZeneca

1,285 total trials

What the finished NCT02601625 record still lists

NCT02601625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 5 interventions - of which Anifrolumab SC injection (300mg) is the first listed.

NCT02601625 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02601625 about?

NCT02601625 is a clinical study titled "A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects". This is a Phase I, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Pharmacokinetics and Safety of anifrolumab following Single-Dose administration to healthy subjects

What is the current status of trial NCT02601625?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2015-11-16. Estimated completion is 2016-05-25.

What interventions are being tested in trial NCT02601625?

The interventions under investigation include: Anifrolumab SC injection (300mg) (DRUG), Anifrolumab IV infusion (300mg) (DRUG), Anifrolumab SC infusion (600mg) (DRUG), Anifrolumab placebo SC injection (300mg) (DRUG), Anifrolumab placebo IV infusion (300mg) (DRUG).

Who is sponsoring clinical trial NCT02601625?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02601625's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 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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Source: ClinicalTrials.gov NCT02601625, the US trial registry maintained by the National Library of Medicine. NCT02601625 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.