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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-16

Study Completion Date

2016-05-25

Brief Summary

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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

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Detailed Description

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This is a Phase I placebo-controlled study to assess the pharmacokinetics, safety and tolerability of 2 doses of anifrolumab via the subcutaneous (SC) route of administration and 1 dose of anifrolumab via intravenous (IV) route in healthy subjects

Conditions

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Safety Pharmacokinetics Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Anifrolumab 300 mg SC injections

300 mg single dose anifrolumab delivered as 2 separate 1 mL SC injections administered serially

Group Type EXPERIMENTAL

Anifrolumab SC injection (300mg)

Intervention Type DRUG

300 mg of anifrolumab delivered as 2 separate 1 mL SC injections administered serially on Day 1

Anifrolumab 300 mg IV infusion

300 mg single dose anifrolumab delivered as an IV infusion over 30 minutes

Group Type EXPERIMENTAL

Anifrolumab IV infusion (300mg)

Intervention Type DRUG

300 mg of anifrolumab delivered as an IV infusion over 30 minutes on Day 1

Anifrolumab 600 mg SC infusion

600 mg single dose anifrolumab or placebo delivered as 4 mL SC by infusion pump

Group Type EXPERIMENTAL

Anifrolumab SC infusion (600mg)

Intervention Type DRUG

600 mg of anifrolumab delivered as 4 mL SC by infusion pump on Day 1

Placebo 300 mg SC injections

300 mg single dose placebo delivered as 2 separate 1 mL SC injections administered serially

Group Type PLACEBO_COMPARATOR

Anifrolumab placebo SC injection (300mg)

Intervention Type DRUG

300mg of placebo delivered as 2 separate 1 mL SC injections administered serially on Day 1

Placebo 300 mg IV infusion

300 mg single dose placebo delivered as an IV infusion over 30 minutes

Group Type PLACEBO_COMPARATOR

Anifrolumab placebo IV infusion (300mg)

Intervention Type DRUG

600mg of placebo delivered as an IV infusion over 30 minutes on Day 1

Placebo 600mg SC infusion

600 mg single dose placebo delivered as 4 mL SC by infusion pump

Group Type PLACEBO_COMPARATOR

Anifrolumab placebo SC infusion (600mg)

Intervention Type DRUG

600 mg of placebo delivered as 4 mL SC by infusion pump on Day 1

Interventions

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Anifrolumab SC injection (300mg)

300 mg of anifrolumab delivered as 2 separate 1 mL SC injections administered serially on Day 1

Intervention Type DRUG

Anifrolumab IV infusion (300mg)

300 mg of anifrolumab delivered as an IV infusion over 30 minutes on Day 1

Intervention Type DRUG

Anifrolumab SC infusion (600mg)

600 mg of anifrolumab delivered as 4 mL SC by infusion pump on Day 1

Intervention Type DRUG

Anifrolumab placebo SC injection (300mg)

300mg of placebo delivered as 2 separate 1 mL SC injections administered serially on Day 1

Intervention Type DRUG

Anifrolumab placebo IV infusion (300mg)

600mg of placebo delivered as an IV infusion over 30 minutes on Day 1

Intervention Type DRUG

Anifrolumab placebo SC infusion (600mg)

600 mg of placebo delivered as 4 mL SC by infusion pump on Day 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Provision of signed and dated, written informed consent prior to any study specific procedures.
2. Healthy male and/or female subjects aged 18 - 55 years.
3. Females must have a negative pregnancy test at screening.
4. Females with an intact cervix must have documentation of a Pap smear with no documented malignancy.
5. Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive, and weigh at least 50 kg.
6. Must have adequate abdominal adipose tissue for SC injection.
7. No history of latent or active TB prior to screening.
8. 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.

Exclusion Criteria

1. History of any clinically significant disease or disorder which may put the subject at risk .
2. History or presence of hepatic or renal disease.
3. Any clinically significant illness, medical/surgical procedure, or trauma within 8 weeks of participation .
4. Any clinically significant chronic or recent infection requiring hospitalization or treatment with anti-infectives.
5. History of cancer, apart from squamous or basal cell carcinoma of the skin.
6. Any clinically significant lab, vital sign or ECG abnormalities as judged by the investigator.
7. Known history of a primary immunodeficiency,HIV splenectomy or an underlying condition.
8. Any positive result on screening for hepatitis B, hepatitis C or HIV antibody.
9. History of drug abuse within 1 year of participation.
10. 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.
11. Previous receipt of:

* Anifrolumab;
* B cell-depleting therapy (including but not limited to epratuzumab, ocrelizumab, or rituximab) ≤ 52 weeks prior to screening.
12. History of allergy/hypersensitivity to drugs with a similar chemical structure or class to anifrolumab or to any human gamma globulin therapy.
13. Any live or attenuated vaccine within 8 weeks prior to participation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes