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

Completed · Phase 1 · Has a placebo group

Conditions studied: Safety, Pharmacokinetics, Healthy Subjects

In brief

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

Key facts

Study ID

NCT02601625

Run by

AstraZeneca

People needed

30

Starts

2015-11-16

Expected to finish

2016-05-25

Last updated by the study team

2019-02-26

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Healthy male and/or female subjects aged 18 - 55 years.
• Females must have a negative pregnancy test at screening.
• Females with an intact cervix must have documentation of a Pap smear with no documented malignancy.
• Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive, and weigh at least 50 kg.
• Must have adequate abdominal adipose tissue for SC injection.
• No history of latent or active TB prior to screening.
• A chest radiograph with no evidence of current active infection or old active TB, malignancy, or clinically significant abnormalities within 6 months prior to screening.

You may not qualify if…

• History of any clinically significant disease or disorder which may put the subject at risk .
• History or presence of hepatic or renal disease.
• Any clinically significant illness, medical/surgical procedure, or trauma within 8 weeks of participation .
• Any clinically significant chronic or recent infection requiring hospitalization or treatment with anti-infectives.
• History of cancer, apart from squamous or basal cell carcinoma of the skin.
• Any clinically significant lab, vital sign or ECG abnormalities as judged by the investigator.
• Known history of a primary immunodeficiency,HIV splenectomy or an underlying condition.
• Any positive result on screening for hepatitis B, hepatitis C or HIV antibody.
• History of drug abuse within 1 year of participation.
• Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 4 weeks or 5 half-lives prior to participation.
• Previous receipt of:
• Anifrolumab;
• B cell-depleting therapy (including but not limited to epratuzumab, ocrelizumab, or rituximab) ≤ 52 weeks prior to screening.
• History of allergy/hypersensitivity to drugs with a similar chemical structure or class to anifrolumab or to any human gamma globulin therapy.
• Any live or attenuated vaccine within 8 weeks prior to participation.

Where it is running

• Research Site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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