SafetyPhase 1NCT02601625
A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects
A Phase 1 study testing Anifrolumab SC injection (300mg), Anifrolumab IV infusion (300mg) and Anifrolumab SC infusion (600mg) in people with Safety and Pharmacokinetics, run by AstraZeneca at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Pharmacokinetics, Healthy Subjects
- What is being tested?
- Anifrolumab SC injection (300mg), Anifrolumab IV infusion (300mg) and Anifrolumab SC infusion (600mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2015to 25 May 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
Read the detailed 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
- Conditions
- Safety, Pharmacokinetics, Healthy Subjects
- Being tested
- Anifrolumab SC injection (300mg), Anifrolumab IV infusion (300mg), Anifrolumab SC infusion (600mg), Anifrolumab placebo SC injection (300mg), Anifrolumab placebo IV infusion (300mg)
- Keywords
- Tolerability, Anifrolumab, Subcutaneous injection, Intravenous infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anifrolumab SC injection (300mg)Drug
300 mg of anifrolumab delivered as 2 separate 1 mL SC injections administered serially on Day 1
Anifrolumab IV infusion (300mg)Drug
300 mg of anifrolumab delivered as an IV infusion over 30 minutes on Day 1
Anifrolumab SC infusion (600mg)Drug
600 mg of anifrolumab delivered as 4 mL SC by infusion pump on Day 1
Anifrolumab placebo SC injection (300mg)Drug
300mg of placebo delivered as 2 separate 1 mL SC injections administered serially on Day 1
Anifrolumab placebo IV infusion (300mg)Drug
600mg of placebo delivered as an IV infusion over 30 minutes on Day 1
Anifrolumab placebo SC infusion (600mg)Drug
600 mg of placebo delivered as 4 mL SC by infusion pump on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Anifrolumab 300 mg SC injections | Experimental | 300 mg single dose anifrolumab delivered as 2 separate 1 mL SC injections administered serially Receives: Drug: Anifrolumab SC injection (300mg) |
| Anifrolumab 300 mg IV infusion | Experimental | 300 mg single dose anifrolumab delivered as an IV infusion over 30 minutes Receives: Drug: Anifrolumab IV infusion (300mg) |
| Anifrolumab 600 mg SC infusion | Experimental | 600 mg single dose anifrolumab or placebo delivered as 4 mL SC by infusion pump Receives: Drug: Anifrolumab SC infusion (600mg) |
| Placebo 300 mg SC injections | Placebo comparator | 300 mg single dose placebo delivered as 2 separate 1 mL SC injections administered serially Receives: Drug: Anifrolumab placebo SC injection (300mg) |
| Placebo 300 mg IV infusion | Placebo comparator | 300 mg single dose placebo delivered as an IV infusion over 30 minutes Receives: Drug: Anifrolumab placebo IV infusion (300mg) |
| Placebo 600mg SC infusion | Placebo comparator | 600 mg single dose placebo delivered as 4 mL SC by infusion pump Receives: Drug: Anifrolumab placebo SC infusion (600mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Observed Maximum Serum Concentration (Cmax) Following Single Dose of Anifrolumab.
To evaluate Cmax of anifrolumab after single administration of two doses subcutaneously and one dose intravenously.
Up to 13 blood samples were collected in total.
Measured: On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days
Pharmacokinetics: Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Following Single Dose of Anifrolumab
To evaluate AUC(0-t) of anifrolumab after single administration of two doses subcutaneously and one dose intravenously
Up to 13 blood samples were collected in total.
Measured: On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days
Pharmacokinetics: Area Under Serum Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) Following Single Dose of Anifrolumab
To evaluate AUC of anifrolumab after single administration of two doses subcutaneously and one dose intravenously.
Up to 13 blood samples were collected in total.
Measured: On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days
Safety: Number of Participants With Adverse Events (AEs)
To assess the safety and tolerability of single doses of anifrolumab
Measured: From screening to final follow-up visit, up to 16 weeks
Safety: Summary of Local Injection Site Pain (SC Cohorts) Assessed in Participants
Local injection site pain was assessed using a 100 mm participant rated Visual Analog Scale (VAS 0mm - 100mm ungraduated scale, where 0 = "no pain" to 100 = "worst imaginable pain"). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average VAS score (0mm-100mm) of the two injection sites were reported.
Measured: Immediately after dosing, at 10, 20 minutes and 1 hour after injection
Safety: Summary of Local Injection Site Pruritus (SC Cohorts) Assessed in Participants
Local injection site pruritus was assessed using a 100 mm participant rated Visual Analog Scale (VAS 0mm - 100mm ungraduated scale, where 0 = "no itching" to 100 = "worst imaginable itching"). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average VAS score (0mm-100mm) of the two injection sites were reported.
Measured: Immediately after dosing, at 10, 20 minutes and 1 hour after injection
Safety: Summary of Erythema Injection Site Reaction (SC Cohorts) Assessed in Participants
Erythema was measured as the largest diameter across the needle site on the skin in millimetres (mm). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average of the two injection site diameters (mm) were reported.
Measured: Immediately after dosing, at 10, 20 minutes and 1 hour after injection
Safety: Summary of the Induration Injection Site Reaction (SC Cohorts) Assessed in Participants
Induration was measured as the largest diameter across the needle site on the skin in millimetres (mm). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average of the two injection site diameters (mm) were reported.
Measured: Immediately after dosing, at 10, 20 minutes and 1 hour after injection
Secondary outcomes (1)
Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA).
Immunogenicity was assessed in all groups by the presence or absence of ADA, which was determined in serum samples using validated bioanalytical methods. The reported results are based on the confirmatory assay (positive/negative) of the ADA. The number of participants with positive, negative and missing results are reported for each time point using the safety analysis set.
Measured: Pre-dose and at Days 5 and Day 29, up to 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study start16 Nov 2015
- Primary completion25 May 2016
- Study completion25 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SafetyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Goldwater, Dr., Principal investigator, PAREXEL Early Phase Clinical Unit, Baltimore, United States of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601625
- Sponsor's protocol ID
- D3461C00006
- Status last verified
- Feb 2019
- First submitted
- 9 Nov 2015
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02601625
- Acronym / sponsor ID
- D3461C00006
- Conditions
- Safety, Pharmacokinetics, Healthy Subjects
- Keywords
- Tolerability, Anifrolumab, Subcutaneous injection, Intravenous infusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2015 (actual)
- Primary completion
- 25 May 2016 (actual)
- Study completion
- 25 May 2016 (actual)
- First posted
- 10 Nov 2015 (estimated)
- Results
- Posted 26 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Anifrolumab 300 mg SC injections | Experimental | Drug: Anifrolumab SC injection (300mg)300 mg single dose anifrolumab delivered as 2 separate 1 mL SC injections administered serially |
| Anifrolumab 300 mg IV infusion | Experimental | Drug: Anifrolumab IV infusion (300mg)300 mg single dose anifrolumab delivered as an IV infusion over 30 minutes |
| Anifrolumab 600 mg SC infusion | Experimental | Drug: Anifrolumab SC infusion (600mg)600 mg single dose anifrolumab or placebo delivered as 4 mL SC by infusion pump |
| Placebo 300 mg SC injections | Placebo comparator | Drug: Anifrolumab placebo SC injection (300mg)300 mg single dose placebo delivered as 2 separate 1 mL SC injections administered serially |
| Placebo 300 mg IV infusion | Placebo comparator | Drug: Anifrolumab placebo IV infusion (300mg)300 mg single dose placebo delivered as an IV infusion over 30 minutes |
| Placebo 600mg SC infusion | Placebo comparator | Drug: Anifrolumab placebo SC infusion (600mg)600 mg single dose placebo delivered as 4 mL SC by infusion pump |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anifrolumab SC injection (300mg)300 mg of anifrolumab delivered as 2 separate 1 mL SC injections administered serially on Day 1 | Drug | Anifrolumab 300 mg SC injections |
| Anifrolumab IV infusion (300mg)300 mg of anifrolumab delivered as an IV infusion over 30 minutes on Day 1 | Drug | Anifrolumab 300 mg IV infusion |
| Anifrolumab SC infusion (600mg)600 mg of anifrolumab delivered as 4 mL SC by infusion pump on Day 1 | Drug | Anifrolumab 600 mg SC infusion |
| Anifrolumab placebo SC injection (300mg)300mg of placebo delivered as 2 separate 1 mL SC injections administered serially on Day 1 | Drug | Placebo 300 mg SC injections |
| Anifrolumab placebo IV infusion (300mg)600mg of placebo delivered as an IV infusion over 30 minutes on Day 1 | Drug | Placebo 300 mg IV infusion |
| Anifrolumab placebo SC infusion (600mg)600 mg of placebo delivered as 4 mL SC by infusion pump on Day 1 | Drug | Placebo 600mg SC infusion |
Primary outcome
Pharmacokinetics: Observed Maximum Serum Concentration (Cmax) Following Single Dose of Anifrolumab.
Time frame: On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days
To evaluate Cmax of anifrolumab after single administration of two doses subcutaneously and one dose intravenously. Up to 13 blood samples were collected in total.
Pharmacokinetics: Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Following Single Dose of Anifrolumab
Time frame: On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days
To evaluate AUC(0-t) of anifrolumab after single administration of two doses subcutaneously and one dose intravenously Up to 13 blood samples were collected in total.
Pharmacokinetics: Area Under Serum Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) Following Single Dose of Anifrolumab
Time frame: On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days
To evaluate AUC of anifrolumab after single administration of two doses subcutaneously and one dose intravenously. Up to 13 blood samples were collected in total.
Safety: Number of Participants With Adverse Events (AEs)
Time frame: From screening to final follow-up visit, up to 16 weeks
To assess the safety and tolerability of single doses of anifrolumab
Safety: Summary of Local Injection Site Pain (SC Cohorts) Assessed in Participants
Time frame: Immediately after dosing, at 10, 20 minutes and 1 hour after injection
Local injection site pain was assessed using a 100 mm participant rated Visual Analog Scale (VAS 0mm - 100mm ungraduated scale, where 0 = "no pain" to 100 = "worst imaginable pain"). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average VAS score (0mm-100mm) of the two injection sites were reported.
Safety: Summary of Local Injection Site Pruritus (SC Cohorts) Assessed in Participants
Time frame: Immediately after dosing, at 10, 20 minutes and 1 hour after injection
Local injection site pruritus was assessed using a 100 mm participant rated Visual Analog Scale (VAS 0mm - 100mm ungraduated scale, where 0 = "no itching" to 100 = "worst imaginable itching"). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average VAS score (0mm-100mm) of the two injection sites were reported.
Safety: Summary of Erythema Injection Site Reaction (SC Cohorts) Assessed in Participants
Time frame: Immediately after dosing, at 10, 20 minutes and 1 hour after injection
Erythema was measured as the largest diameter across the needle site on the skin in millimetres (mm). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average of the two injection site diameters (mm) were reported.
Safety: Summary of the Induration Injection Site Reaction (SC Cohorts) Assessed in Participants
Time frame: Immediately after dosing, at 10, 20 minutes and 1 hour after injection
Induration was measured as the largest diameter across the needle site on the skin in millimetres (mm). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average of the two injection site diameters (mm) were reported.
1 secondary outcome
Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA).
Time frame: Pre-dose and at Days 5 and Day 29, up to 85 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- d3461c00006-revised-study-protocol-1\_REDACTEDLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Goldwater, Dr. principal investigator
PAREXEL Early Phase Clinical Unit, Baltimore, United States of America
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anifrolumab SC injection (300mg), Anifrolumab IV infusion (300mg) and Anifrolumab SC infusion (600mg) in people with Safety and Pharmacokinetics, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics: Observed Maximum Serum Concentration (Cmax) Following Single Dose of Anifrolumab. (time frame: On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.