A study to assess the pharmacokinetics and safety of single doses of Anifrolumab in healthy subjects

Study identifier:D3461C00006

ClinicalTrials.gov identifier:NCT02601625

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomized, phase 1, placebo-controlled, double-blind, single-dose study to evaluate the safety, tolerability and pharmacokinetics of subcutaneously and intravenously delivered Anifrolumab in healthy subjects.

Medical condition

Safety, Healthy subjects

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Anifrolumab SC injection (300mg), Anifrolumab IV infusion (300mg), Anifrolumab SC infusion (600mg), Anifrolumab placebo SC injection (300mg), Anifrolumab placebo IV infusion (300mg), Anifrolumab placebo SC infusion (600mg)

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 16 Nov 2015

Primary Completion Date: 25 May 2016

Study Completion Date: 25 May 2016

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 Dec 2022 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

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.

No locations available

Arms	Assigned Interventions
Experimental: Anifrolumab 300 mg SC injections 300 mg single dose anifrolumab delivered as 2 separate 1 mL SC injections administered serially	Drug: Anifrolumab SC injection (300mg) 300 mg of anifrolumab delivered as 2 separate 1 mL SC injections administered serially on Day 1
Experimental: Anifrolumab 300 mg IV infusion 300 mg single dose anifrolumab delivered as an IV infusion over 30 minutes	Drug: Anifrolumab IV infusion (300mg) 300 mg of anifrolumab delivered as an IV infusion over 30 minutes on Day 1
Experimental: Anifrolumab 600 mg SC infusion 600 mg single dose anifrolumab or placebo delivered as 4 mL SC by infusion pump	Drug: Anifrolumab SC infusion (600mg) 600 mg of anifrolumab delivered as 4 mL SC by infusion pump on Day 1
Placebo Comparator: Placebo 300 mg SC injections 300 mg single dose placebo delivered as 2 separate 1 mL SC injections administered serially	Drug: Anifrolumab placebo SC injection (300mg) 300mg of placebo delivered as 2 separate 1 mL SC injections administered serially on Day 1
Placebo Comparator: Placebo 300 mg IV infusion 300 mg single dose placebo delivered as an IV infusion over 30 minutes	Drug: Anifrolumab placebo IV infusion (300mg) 600mg of placebo delivered as an IV infusion over 30 minutes on Day 1
Placebo Comparator: Placebo 600mg SC infusion 600 mg single dose placebo delivered as 4 mL SC by infusion pump	Drug: Anifrolumab placebo SC infusion (600mg) 600 mg of placebo delivered as 4 mL SC by infusion pump on Day 1

Documents available

d3461c00006-revised-study-protocol-1_REDACTED
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Ronald Goldwater

PAREXEL Early Phase Clinical Unit, Baltimore, United States of America