Healthy ParticipantsPhase 1NCT05751642
Safety and Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN1920 in Healthy Participants
A Phase 1 study testing ALXN1920 in people with Healthy Participants, run by Alexion Pharmaceuticals, Inc. at 2 sites in New Zealand.
Trial summary
This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single ascending doses (SADs) of ALXN1920 subcutaneous (SC) and of a single dose of ALXN1920 intravenous (IV) in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- ALXN1920
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 19 Apr 2023to 4 Dec 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants
- Body mass index within 18.0 to 32.0 kg/m^2 (inclusive), with a minimum body weight of 50.0 kg.
- Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.
- For Cohort 6, participants of Japanese descent, defined as having both parents and 4 grandparents who are ethnically Japanese.
Who cannot join
- Significant history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
- History of significant allergic reaction.
- History of any Neisseria infection
- Active systemic bacterial, viral, or fungal infection.
- Participants who at Day -1 are either testing positive for coronavirus disease 2019 (COVID-19), or have not had at least 4 weeks elapse of recovery time (a negative test), or are experiencing long-term COVID-19-related sequelae.
- Any major surgery within 8 weeks of Screening.
Show all 10Show fewer
- Known or suspected history of drug or alcohol abuse.
- Current tobacco users or smokers.
- Positive Human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C viral infection.
- Female participant who are pregnant, breastfeeding, or intending to conceive during the course of the study.
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Research Site
Christchurch, 8011
Clinical Trial Site
Grafton, Auckland, 1010
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Subcutaneously and Intravenously Administered ALXN1920 in Healthy Adult Participants
This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single ascending doses (SADs) of ALXN1920 subcutaneous (SC) and of a single dose of ALXN1920 intravenous (IV) in healthy adult participants.
Read the detailed description
This is a first-in-human study in healthy adult participants.
Eligible participants will be randomly assigned in a 3:1 (ALXN1920:Placebo) ratio in each of the treatment cohorts. The first 2 participants randomized to each cohort will be dosed as a sentinel pair, with 1 participant on active treatment and 1 participant on placebo. At the discretion of the Investigator, up to 3 more participants will be added at least 48 hours after the dosing of the sentinel pair, followed by dosing of the remaining participants in the cohort no earlier than 72 hours after sentinel pair dosing.
The study will comprise:
A Screening Period of up to 28 days; A Dosing Period (single dose through to Follow-up Visit) of approximately 28 days; A Final Follow-up period and end of study Visit is planned on Day 29.
Each participant will be involved in the study for approximately 56 days.
- Conditions
- Healthy Participants
- Being tested
- ALXN1920, Placebo
- Keywords
- First-in-human, Single ascending dose, Sentinel dosing, ALXN1920, Safety, Pharmacokinetics, Pharmacodynamics, Japanese Descent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN1920Biological
Participants will receive a single dose of ALXN1920 by Subcutaneous (SC) injection.
PlaceboBiological
Participants will receive a single dose of Placebo by SC injection, SC infusion or IV infusion.
ALXN1920Biological
Participants will receive a single dose of ALXN1920 by SC infusion.
ALXN1920Biological
Participants will receive a single dose of ALXN1920 by Intravenous (IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive a single dose of ALXN1920. Receives: Biological: ALXN1920 |
| Cohort 2 | Experimental | Participants will receive a single dose of ALXN1920. Receives: Biological: ALXN1920 |
| Cohort 3 | Experimental | Participants will receive a single dose of ALXN1920. Receives: Biological: ALXN1920 |
| Cohort 4 | Experimental | Participants will receive a single dose of ALXN1920. Receives: Biological: ALXN1920 |
| Cohort 5 | Experimental | Participants will receive a single dose of ALXN1920. Receives: Biological: ALXN1920 |
| Cohort 6: Japanese Cohort | Experimental | Japanese participants will receive a single dose of ALXN1920. Receives: Biological: ALXN1920 |
| Pooled Placebo | Placebo comparator | Participants will receive Placebo. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse events (AEs)
To assess the safety and tolerability of single ascending doses of ALXN1920.
Measured: Up to End of study visit (Day 29)
Secondary outcomes (17)
Maximum observed concentration (Cmax)
To assess the Cmax of ALXN1920 following single ascending doses of ALXN1920.
Measured: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Time to maximum observed concentration (tmax)
To assess the tmax of ALXN1920 following single ascending doses of ALXN1920.
Measured: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Area under the concentration-time curve from time 0 (dosing) to the last quantifiable concentration (AUC0-t)
To assess the AUC0-t of ALXN1920 following single ascending doses of ALXN1920.
Measured: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Area under the concentration-time curve from time 0 (dosing) to time infinity (AUCinf)
To assess the AUCinf of ALXN1920 following single ascending doses of ALXN1920.
Measured: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Terminal elimination half-life (t½)
To assess the t½ of ALXN1920 following single ascending doses of ALXN1920.
Measured: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Terminal-phase elimination rate constant (λz)
To assess the λz of ALXN1920 following single ascending doses of ALXN1920.
Measured: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Total body clearance (CL)
To assess the CL of ALXN1920 following single ascending doses of ALXN1920.
Measured: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Apparent clearance (CL/F)
To assess the CL/F of ALXN1920 following single ascending doses of ALXN1920.
Measured: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Volume of distribution (Vd)
To assess the Vd of ALXN1920 following single ascending doses of ALXN1920.
Measured: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Apparent volume of distribution (Vd/F)
To assess the Vd/F of ALXN1920 following single ascending doses of ALXN1920.
Measured: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Renal clearance (CLR)
To assess the CLR of ALXN1920 following single ascending doses of ALXN1920.
Measured: Day 1 through Day 5 (Pre-dose and up to 96 hours post-dose)
Amount of unchanged drug excreted in urine (Ae)
To assess the Ae of ALXN1920 following single ascending doses of ALXN1920.
Measured: Day 1 through Day 5 (Pre-dose and up to 96 hours post-dose)
Fraction of dose excreted in urine (fe)
To assess the fe of ALXN1920 following single ascending doses of ALXN1920.
Measured: Day 1 through Day 5 (Pre-dose and up to 96 hours post-dose)
Change in complement alternative pathway (CAP) activity
To explore the Pharmacodynamic (PD) effects of single ascending doses of ALXN1920. CAP activity will be assessed using the CAP hemolytic assay.
Measured: Day 1 (Pre-dose, 0.5, 1 and 2 hours post-dose), post-dose on Day 2, 3, 4, 5, 8, 15, 22, and 29
Change in factor H
To explore the PD effects of single ascending doses of ALXN1920. Change in factor H will be assessed using the factor H assay.
Measured: Day 1 (Pre-dose, 0.5, 1 and 2 hours post-dose), post-dose on Day 2, 3, 4, 5, 8, 15, 22, and 29
Number of Participants With Positive Antidrug Antibodies (ADAs) to ALXN1920
To assess the immunogenicity to ALXN1920.
Measured: Day 1 pre-dose and Day 29 post-dose
Geometric Mean Ratio (GMR) of Area Under the Curve (AUC) Values of Subcutaneous (SC) Versus Intravenous (IV) Serum Concentration of ALXN1920
To assess the absolute bioavailability of ALXN1920 SC.
Measured: Day 29 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start19 Apr 2023
- Primary completion4 Dec 2023
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751642
- Sponsor's protocol ID
- ALXN1920-HV-101
- Status last verified
- Nov 2024
- First submitted
- 21 Feb 2023
- Last updated
- 27 Nov 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. All request 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 shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Subcutaneously and Intravenously Administered ALXN1920 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05751642
- Acronym / sponsor ID
- ALXN1920-HV-101
- Conditions
- Healthy Participants
- Keywords
- First-in-human, Single ascending dose, Sentinel dosing, ALXN1920, Safety, Pharmacokinetics, Pharmacodynamics, Japanese Descent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 2 Mar 2023 (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 assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single ascending doses (SADs) of ALXN1920 subcutaneous (SC) and of a single dose of ALXN1920 intravenous (IV) in healthy adult participants.
Detailed description
This is a first-in-human study in healthy adult participants.
Eligible participants will be randomly assigned in a 3:1 (ALXN1920:Placebo) ratio in each of the treatment cohorts. The first 2 participants randomized to each cohort will be dosed as a sentinel pair, with 1 participant on active treatment and 1 participant on placebo. At the discretion of the Investigator, up to 3 more participants will be added at least 48 hours after the dosing of the sentinel pair, followed by dosing of the remaining participants in the cohort no earlier than 72 hours after sentinel pair dosing.
The study will comprise:
A Screening Period of up to 28 days; A Dosing Period (single dose through to Follow-up Visit) of approximately 28 days; A Final Follow-up period and end of study Visit is planned on Day 29.
Each participant will be involved in the study for approximately 56 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: ALXN1920Participants will receive a single dose of ALXN1920. |
| Cohort 2 | Experimental | Biological: ALXN1920Participants will receive a single dose of ALXN1920. |
| Cohort 3 | Experimental | Biological: ALXN1920Participants will receive a single dose of ALXN1920. |
| Cohort 4 | Experimental | Biological: ALXN1920Participants will receive a single dose of ALXN1920. |
| Cohort 5 | Experimental | Biological: ALXN1920Participants will receive a single dose of ALXN1920. |
| Cohort 6: Japanese Cohort | Experimental | Biological: ALXN1920Japanese participants will receive a single dose of ALXN1920. |
| Pooled Placebo | Placebo comparator | Biological: PlaceboParticipants will receive Placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy participants
- Body mass index within 18.0 to 32.0 kg/m^2 (inclusive), with a minimum body weight of 50.0 kg.
- Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.
- For Cohort 6, participants of Japanese descent, defined as having both parents and 4 grandparents who are ethnically Japanese.
Key exclusion criteria (10 listed)
- Significant history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
- History of significant allergic reaction.
- History of any Neisseria infection
- Active systemic bacterial, viral, or fungal infection.
- Participants who at Day -1 are either testing positive for coronavirus disease 2019 (COVID-19), or have not had at least 4 weeks elapse of recovery time (a negative test), or are experiencing long-term COVID-19-related sequelae.
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 |
|---|---|---|
| ALXN1920Participants will receive a single dose of ALXN1920 by Subcutaneous (SC) injection. | Biological | Cohort 1, Cohort 2 |
| PlaceboParticipants will receive a single dose of Placebo by SC injection, SC infusion or IV infusion. | Biological | Pooled Placebo |
| ALXN1920Participants will receive a single dose of ALXN1920 by SC infusion. | Biological | Cohort 3, Cohort 4, Cohort 6: Japanese Cohort |
| ALXN1920Participants will receive a single dose of ALXN1920 by Intravenous (IV) infusion. | Biological | Cohort 5 |
Primary outcome
Number of participants with Adverse events (AEs)
Time frame: Up to End of study visit (Day 29)
To assess the safety and tolerability of single ascending doses of ALXN1920.
17 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Time to maximum observed concentration (tmax)
Time frame: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Area under the concentration-time curve from time 0 (dosing) to the last quantifiable concentration (AUC0-t)
Time frame: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Area under the concentration-time curve from time 0 (dosing) to time infinity (AUCinf)
Time frame: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Terminal elimination half-life (t½)
Time frame: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Terminal-phase elimination rate constant (λz)
Time frame: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Total body clearance (CL)
Time frame: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Apparent clearance (CL/F)
Time frame: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Volume of distribution (Vd)
Time frame: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Apparent volume of distribution (Vd/F)
Time frame: Day 1 (Pre-dose, 0.5, 1, 2, 6 and 12 hours post-dose), post-dose on Day 2, 3, 4, 5, 6, 8, 15, 22, and 29
Renal clearance (CLR)
Time frame: Day 1 through Day 5 (Pre-dose and up to 96 hours post-dose)
Amount of unchanged drug excreted in urine (Ae)
Time frame: Day 1 through Day 5 (Pre-dose and up to 96 hours post-dose)
Fraction of dose excreted in urine (fe)
Time frame: Day 1 through Day 5 (Pre-dose and up to 96 hours post-dose)
Change in complement alternative pathway (CAP) activity
Time frame: Day 1 (Pre-dose, 0.5, 1 and 2 hours post-dose), post-dose on Day 2, 3, 4, 5, 8, 15, 22, and 29
Change in factor H
Time frame: Day 1 (Pre-dose, 0.5, 1 and 2 hours post-dose), post-dose on Day 2, 3, 4, 5, 8, 15, 22, and 29
Number of Participants With Positive Antidrug Antibodies (ADAs) to ALXN1920
Time frame: Day 1 pre-dose and Day 29 post-dose
Geometric Mean Ratio (GMR) of Area Under the Curve (AUC) Values of Subcutaneous (SC) Versus Intravenous (IV) Serum Concentration of ALXN1920
Time frame: Day 29 post-dose
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 27 Nov 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. All request 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 shared.
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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 ALXN1920 in people with Healthy Participants, run by Alexion Pharmaceuticals, Inc. at 2 sites in New Zealand.
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 4 inclusion and 10 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 27 Nov 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 New Zealand. 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?
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?
Number of participants with Adverse events (AEs) (time frame: Up to End of study visit (Day 29)). 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 27 Nov 2024.