Healthy Adult ParticipantsPhase 1NCT06208488
A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants
A Phase 1 study testing Gefurulimab PFS-SD and Gefurulimab AI in people with Healthy Adult Participants, run by Alexion Pharmaceuticals, Inc. at 2 sites in Canada.
Trial summary
This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, immunogenicity, and device performance of gefurulimab. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Gefurulimab PFS-SD and Gefurulimab AI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 2 sitesCanada
- Study dates
- 22 Nov 2023to 28 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Body weight within ≥ 50 to < 110 kg and body mass index (BMI) within the range 18.5 to 30 kg/m2 (inclusive)
- Participants who are healthy as determined by medical evaluation with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluation.
- QT interval corrected using Fridericia's formula (QTcF) ≤ 450 msec for male participants and ≤ 460 msec for female participants at Screening and prior to dosing on Day 1.
- Documented vaccination against meningococcal infection from serogroups A, C, W, and Y and serogroup B.
- Male and female participants should adhere to study-specific contraceptive methods.
Who cannot join
- History of any Neisseria meningitidis infection.
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
- Abnormal blood pressure as determined by the Investigator.
- History of latent or active TB (Tuberculosis) or exposure to endemic areas.
- Allergy to monoclonal antibodies.
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe posttreatment hypersensitivity reactions.
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- Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Current or chronic history of liver disease.
- Known hepatic or biliary abnormalities.
- Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing.
- History of allergy or intolerance to penicillin or cephalosporin.
- History of clinically significant allergic reaction (eg, anaphylaxis or angioedema) to any product.
- Live vaccine(s) within 1 month prior to Screening or plans to receive such vaccines during the study.
- Evidence of human immunodeficiency virus (HIV) infection (positive HIV type 1 or type 2 antibody).
- Evidence of hepatitis B infection (positive hepatitis B surface antigen [HBsAg] or positive total hepatitis B core antibody [HBcAb] with negative surface antibody [anti-HBs]), or hepatitis C viral infection (positive HCV RNA).
- Female participants who have a positive pregnancy test at Screening or Admission.
- Positive prestudy drug/alcohol screen; positive result may be repeated once.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Research Site
Laval, Quebec, h7v 4bc
Research Site
Toronto, Ontario, M9L 3A2
About this study
Official title: A Phase 1, Open-label, Randomized, Parallel-group Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Immunogenicity, and Device Performance of ALXN1720 (Gefurulimab) Administered Subcutaneously Using Prefilled Syringe Versus Autoinjector in Adult Healthy Participants
This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, immunogenicity, and device performance of gefurulimab.
Read the detailed description
This is an open-label, randomized, parallel-group study.
The study consists of 2 periods: a Screening Period (up to 70 days), and an Evaluation Period of 92 days.
Separate randomization lists will be produced for each weight stratum (50 to < 70 kg, 70 to < 90 kg, and 90 to < 110 kg) and within each of the three weight strata, participants will be randomized 1:1:1:1:1:1 to one of the six combinations of device (prefilled syringe with needle safety device [PFS-SD] or autoinjector [AI]) and injection site (abdomen, thigh, or upper arm),
Participants will receive a single dose of 600 mg gefurulimab on Day 1, will be residential at the clinical unit until Day 5, will have visits on Day 8, quaque week (once a week) [qw] thereafter until Day 50, and quaque 2 week (once every two weeks) [q2w] from Day 50 until Day 92 during the Evaluation Period.
The total study duration is up to 162 days.
- Conditions
- Healthy Adult Participants
- Being tested
- Gefurulimab PFS-SD, Gefurulimab AI
- Keywords
- Pharmacokinetics, Pharmacodynamics, Safety, Immunogenicity, Device Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gefurulimab PFS-SDDrug
Also called ALXN1720
Participants will receive a single 600 mg dose of Gefurulimab PFS-SD subcutaneously (SC) on Day 1.
Gefurulimab AIDrug
Also called ALXN1720
Participants will receive a single 600 mg dose of Gefurulimab AI subcutaneously (SC) on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Gefurulimab PFS-SD | Experimental | Participants will be administered gefurulimab as a single dose of 600 mg by PFS-SD on the abdomen, thigh, or upper arm. Receives: Drug: Gefurulimab PFS-SD |
| Gefurulimab AI | Experimental | Participants will be administered gefurulimab as a single dose of 600 mg by AI on the abdomen, thigh, or upper arm. Receives: Drug: Gefurulimab AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum concentration-time curve from time zero to the last measurable concentration (AUClast)
The AUClast exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed.
Measured: Day 1 up to early discontinuation or Day 92
Area under the serum concentration-time curve from time zero to time infinity (AUCinf)
The AUClinf exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed.
Measured: Day 1 up to early discontinuation or Day 92
Maximum (peak) concentration observed after study intervention administration (Cmax)
The Cmax exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed.
Measured: Day 1 up to early discontinuation or Day 92
Secondary outcomes (9)
Time to maximum observed serum concentration (tmax)
The tmax of gefurulimab SC in healthy participants across devices, and injection sites will be assessed.
Measured: Day 1 to Day 92
Terminal elimination half-life (t½)
The t½ of gefurulimab SC in healthy participants across devices, and injection sites will be assessed.
Measured: Day 1 to Day 92
Apparent total body clearance of the study intervention from serum (CL/F)
The CL/F of gefurulimab SC in healthy participants across devices, and injection sites will be assessed.
Measured: Day 1 to Day 92
Apparent volume of distribution (Vd/F)
The Vd/F of gefurulimab SC in healthy participants across devices, and injection sites will be assessed.
Measured: Day 1 to Day 92
Serum free C5 (complement component 5) concentrations
The serum free C5 concentrations of gefurulimab SC in healthy participants across devices and injection sites will be assessed.
Measured: Day 1 to Day 92
Number of subjects with TEAEs (treatment-emergent adverse event) and TESAEs (treatment-emergent serious adverse event)
The safety and tolerability of gefurulimab SC in healthy participants across devices and injection sites will be evaluated.
Measured: From Admission (Day-1) to Day 92
Incidence of antidrug antibody (ADA) to gefurulimab category of immune-response and titer
The immunogenicity of gefurulimab SC administered with either PFS-SD or AI in healthy participants will be assessed.
Measured: Day 1, Day 92
Number of reported outcome of attempted full-dose administration via AI (autoinjector) or PFS-SD (prefilled syringe with needle safety device)
The performance of the AI and PFS-SD in the administration of gefurulimab SC in healthy participants will be assessed.
Measured: Day 1
Number of reported device deficiencies/complaints and associated device investigations
The performance of the AI and PFS-SD in the administration of gefurulimab SC in healthy participants will be assessed.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start22 Nov 2023
- Primary completion17 Sep 2024
- Study completion28 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Separate randomization lists will be produced for each weight stratum (ie, 50 to \< 70 kg, 70 to \< 90 kg, and 90 to \< 110 kg) and within each of the three weight strata, participants will be randomized 1:1:1:1:1:1 to one of the six combinations of device (PFS-SD or AI) and injection site (abdomen, thigh, or upper arm).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208488
- Sponsor's protocol ID
- ALXN1720-HV-103
- Status last verified
- Oct 2024
- First submitted
- 6 Nov 2023
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Parallel-group Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Immunogenicity, and Device Performance of ALXN1720 (Gefurulimab) Administered Subcutaneously Using Prefilled Syringe Versus Autoinjector in Adult Healthy Participants
- ClinicalTrials.gov ID
- NCT06208488
- Acronym / sponsor ID
- ALXN1720-HV-103
- Conditions
- Healthy Adult Participants
- Keywords
- Pharmacokinetics, Pharmacodynamics, Safety, Immunogenicity, Device Performance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 17 Sep 2024 (actual)
- Study completion
- 28 Sep 2024 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, immunogenicity, and device performance of gefurulimab.
Detailed description
This is an open-label, randomized, parallel-group study.
The study consists of 2 periods: a Screening Period (up to 70 days), and an Evaluation Period of 92 days.
Separate randomization lists will be produced for each weight stratum (50 to < 70 kg, 70 to < 90 kg, and 90 to < 110 kg) and within each of the three weight strata, participants will be randomized 1:1:1:1:1:1 to one of the six combinations of device (prefilled syringe with needle safety device [PFS-SD] or autoinjector [AI]) and injection site (abdomen, thigh, or upper arm),
Participants will receive a single dose of 600 mg gefurulimab on Day 1, will be residential at the clinical unit until Day 5, will have visits on Day 8, quaque week (once a week) [qw] thereafter until Day 50, and quaque 2 week (once every two weeks) [q2w] from Day 50 until Day 92 during the Evaluation Period.
The total study duration is up to 162 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Separate randomization lists will be produced for each weight stratum (ie, 50 to < 70 kg, 70 to < 90 kg, and 90 to < 110 kg) and within each of the three weight strata, participants will be randomized 1:1:1:1:1:1 to one of the six combinations of device (PFS-SD or AI) and injection site (abdomen, thigh, or upper arm).
| Arm | Type | Receives |
|---|---|---|
| Gefurulimab PFS-SD | Experimental | Drug: Gefurulimab PFS-SDParticipants will be administered gefurulimab as a single dose of 600 mg by PFS-SD on the abdomen, thigh, or upper arm. |
| Gefurulimab AI | Experimental | Drug: Gefurulimab AIParticipants will be administered gefurulimab as a single dose of 600 mg by AI on the abdomen, thigh, or upper arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- Body weight within ≥ 50 to < 110 kg and body mass index (BMI) within the range 18.5 to 30 kg/m2 (inclusive)
- Participants who are healthy as determined by medical evaluation with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluation.
- QT interval corrected using Fridericia's formula (QTcF) ≤ 450 msec for male participants and ≤ 460 msec for female participants at Screening and prior to dosing on Day 1.
- Documented vaccination against meningococcal infection from serogroups A, C, W, and Y and serogroup B.
Key exclusion criteria (17 listed)
- History of any Neisseria meningitidis infection.
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
- Abnormal blood pressure as determined by the Investigator.
- History of latent or active TB (Tuberculosis) or exposure to endemic areas.
- Allergy to monoclonal antibodies.
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 |
|---|---|---|
| Gefurulimab PFS-SDAlso: ALXN1720Participants will receive a single 600 mg dose of Gefurulimab PFS-SD subcutaneously (SC) on Day 1. | Drug | Gefurulimab PFS-SD |
| Gefurulimab AIAlso: ALXN1720Participants will receive a single 600 mg dose of Gefurulimab AI subcutaneously (SC) on Day 1. | Drug | Gefurulimab AI |
Primary outcome
Area under the serum concentration-time curve from time zero to the last measurable concentration (AUClast)
Time frame: Day 1 up to early discontinuation or Day 92
The AUClast exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed.
Area under the serum concentration-time curve from time zero to time infinity (AUCinf)
Time frame: Day 1 up to early discontinuation or Day 92
The AUClinf exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed.
Maximum (peak) concentration observed after study intervention administration (Cmax)
Time frame: Day 1 up to early discontinuation or Day 92
The Cmax exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed.
9 secondary outcomes
Time to maximum observed serum concentration (tmax)
Time frame: Day 1 to Day 92
Terminal elimination half-life (t½)
Time frame: Day 1 to Day 92
Apparent total body clearance of the study intervention from serum (CL/F)
Time frame: Day 1 to Day 92
Apparent volume of distribution (Vd/F)
Time frame: Day 1 to Day 92
Serum free C5 (complement component 5) concentrations
Time frame: Day 1 to Day 92
Number of subjects with TEAEs (treatment-emergent adverse event) and TESAEs (treatment-emergent serious adverse event)
Time frame: From Admission (Day-1) to Day 92
Incidence of antidrug antibody (ADA) to gefurulimab category of immune-response and titer
Time frame: Day 1, Day 92
Number of reported outcome of attempted full-dose administration via AI (autoinjector) or PFS-SD (prefilled syringe with needle safety device)
Time frame: Day 1
Number of reported device deficiencies/complaints and associated device investigations
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gefurulimab PFS-SD and Gefurulimab AI in people with Healthy Adult Participants, run by Alexion Pharmaceuticals, Inc. at 2 sites in Canada.
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 6 inclusion and 17 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 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the serum concentration-time curve from time zero to the last measurable concentration (AUClast) (time frame: Day 1 up to early discontinuation or Day 92). The study lists 3 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 23 Oct 2024.