Phase 1
N=30
A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects
Safety · Pharmacokinetics · Healthy Subjects
Bottom Line
View on ClinicalTrials.gov: NCT02601625 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Pharmacokinetics: Observed Maximum Serum Concentration (Cmax) Following Single Dose of Anifrolumab. — 36.22; 82.44; 63.86 ug/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 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); Anifrolumab placebo SC infusion (600mg) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Observed Maximum Serum Concentration (Cmax) Following Single Dose of Anifrolumab. |
36.22; 82.44; 63.86 | — |
| PRIMARY Pharmacokinetics: Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Following Single Dose of Anifrolumab |
769.1; 902.9; 1639 | — |
| PRIMARY Pharmacokinetics: Area Under Serum Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) Following Single Dose of Anifrolumab |
784.6; 906.5; 1828 | — |
| PRIMARY Safety: Number of Participants With Adverse Events (AEs) |
3; 2; 4; 4; 1; 2 | — |
| PRIMARY Safety: Summary of Local Injection Site Pain (SC Cohorts) Assessed in Participants |
1.2; 0.0; 8.0; 0.0; 0.5; 0.0 | — |
| PRIMARY Safety: Summary of Local Injection Site Pruritus (SC Cohorts) Assessed in Participants |
1.3; 14.0; 1.3; 0.8; 0.7; 6.3 | — |
| PRIMARY Safety: Summary of Erythema Injection Site Reaction (SC Cohorts) Assessed in Participants |
0.3; 17.0; 11.5; 20.0; 2.0; 17.5 | — |
| PRIMARY Safety: Summary of the Induration Injection Site Reaction (SC Cohorts) Assessed in Participants |
4.2; 22.5; 0.0; 12.5; 0.8; 17.3 | — |
| SECONDARY Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA). |
0; 0; 0; 0; 0; 6 | — |
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
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02601625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.