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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects; Pharmacokinetics; Safety

Treatments: Drug: Anifrolumab SC injection (300mg); Drug: Anifrolumab placebo SC infusion (600mg); Drug: Anifrolumab IV infusion (300mg); Drug: Anifrolumab SC infusion (600mg); Drug: Anifrolumab placebo SC injection (300mg); Drug: Anifrolumab placebo IV infusion (300mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02601625

D3461C00006

Details and patient eligibility

About

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

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 6 patient groups, including a placebo group

Anifrolumab 300 mg SC injections

Experimental group

Description:

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

Treatment:

Drug: Anifrolumab SC injection (300mg)

Anifrolumab 300 mg IV infusion

Experimental group

Description:

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

Treatment:

Drug: Anifrolumab IV infusion (300mg)

Anifrolumab 600 mg SC infusion

Experimental group

Description:

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

Treatment:

Drug: Anifrolumab SC infusion (600mg)

Placebo 300 mg SC injections

Placebo Comparator group

Description:

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

Treatment:

Drug: Anifrolumab placebo SC injection (300mg)

Placebo 300 mg IV infusion

Placebo Comparator group

Description:

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

Treatment:

Drug: Anifrolumab placebo IV infusion (300mg)

Placebo 600mg SC infusion

Placebo Comparator group

Description:

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

Treatment:

Drug: Anifrolumab placebo SC infusion (600mg)