HealthyPhase 1NCT05254613
A Study of Single and Multiple SC Doses of ALXN1830 in Healthy Adult Participants
A Phase 1 study testing ALXN1830 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United Kingdom.
Trial summary
This study will evaluate the effects of single ascending doses (SAD) and multiple ascending doses (MAD) of ALXN1830 administered subcutaneously (SC) to healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ALXN1830
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Nov 2019to 22 Jan 2021
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Satisfactory medical assessment.
- Participants must have had vaccination against pneumococcus (Pneumovax 23 [PPSV23]) at least 28 days, and maximally 4 years prior to Day 1.
- Participants must have had seasonal influenza vaccination for the current season at least 28 days prior to Day 1.
- Body weight within 50 to 90 kg, inclusive, and body mass index (BMI) within the range of 18 to 24.9 kg/m^2, inclusive.
- Must be willing to follow protocol-specified contraception guidance during the study and for up to 3 months after last dose of study drug.
Who cannot join
- Current/recurrent diseases or relevant medical history.
- Known exposure to therapeutic proteins, such as monoclonal antibodies, including marketed drugs prior to dosing.
- Participants who have prior exposure to ALXN1830.
- Exposure to more than 4 new (small molecule) investigational compounds within 12 months prior to dosing.
- Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study.
- Presence of hepatitis B surface antigen (HBsAg) at Screening.
Show all 9Show fewer
- Positive hepatitis C antibody test result at Screening.
- Positive human immunodeficiency virus (HIV) antibody test at Screening.
- Participants who are either immunocompromised or have one of the following underlying medical conditions: anatomic or functional asplenia (including sickle cell disease); primary antibody deficiencies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants
This study will evaluate the effects of single ascending doses (SAD) and multiple ascending doses (MAD) of ALXN1830 administered subcutaneously (SC) to healthy adult participants.
Read the detailed description
This Phase 1 study will consist of 3 SAD (Cohorts 1 to 3) and 4 MAD (Cohorts 4 to 7) cohorts. Participants will be randomly assigned in a 6:2 ratio to each of the 7 cohorts to receive either single or multiple doses of ALXN1830 (n = 6 per cohort) or single or multiple doses of placebo (n = 2 per cohort).
- Conditions
- Healthy
- Being tested
- ALXN1830, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN1830Drug
ALXN1830 will be administered as SC infusion(s).
PlaceboDrug
Placebo will be administered as SC infusion(s).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive a single SC dose of ALXN1830 or placebo (750 mg). Receives: Drug: ALXN1830; Drug: Placebo |
| Cohort 2 | Experimental | Participants will receive a single SC dose of ALXN1830 or placebo (1500 mg). Receives: Drug: ALXN1830; Drug: Placebo |
| Cohort 3 | Experimental | Participants will receive a single SC dose of ALXN1830 or placebo (2250 mg). Receives: Drug: ALXN1830; Drug: Placebo |
| Cohort 4 | Experimental | Participants will receive multiple SC doses of ALXN1830 or placebo (300 mg twice weekly; 8 doses total). Receives: Drug: ALXN1830; Drug: Placebo |
| Cohort 5 | Experimental | Participants will receive multiple SC doses of ALXN1830 or placebo (750 mg once weekly; 12 doses total). Receives: Drug: ALXN1830; Drug: Placebo |
| Cohort 6 | Experimental | Participants will receive multiple SC doses of ALXN1830 or placebo (1500 mg once weekly; 4 doses total). Receives: Drug: ALXN1830; Drug: Placebo |
| Cohort 7 | Experimental | Participants will receive multiple SC doses of ALXN1830 or placebo (2250 mg once weekly; 4 doses total). Receives: Drug: ALXN1830; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
A TEAE was defined as any adverse event (AE) that commences after the start of administration of study drug. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An AE was considered serious if, in the view of the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. A summary of all serious AEs and other AEs (nonserious) regardless of causality is located in 'Adverse events' Section.
Measured: Baseline up to Day 64
Secondary outcomes (4)
Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To The Last Quantifiable Concentration (AUC0-t) of ALXN1830
Measured: Predose, end of infusion, and 0.5, 2, 4, 8, and 12 hours postdose on Day 1; and Days 2 to 8
Percent Change From Baseline in Immunoglobulin G (IgG) Levels at Day 10
Measured: Baseline, Day 10
Number of Participants With Positive Anti-Drug Antibodies (ADA)
Measured: Baseline up to Day 64
Number of Participants With Positive Neutralizing Antibodies (NAbs)
All samples that are confirmed positive for ADA were evaluated for the presence of neutralizing antibodies.
Measured: Baseline up to Day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start12 Nov 2019
- Primary completion22 Jan 2021
- Study completion22 Jan 2021
Why it stopped: The justification of the early termination of the trial: the study is early terminated due to the Coronavirus 2019 epidemic.
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 HealthyStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 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
- NCT05254613
- Sponsor's protocol ID
- ALXN1830-HV-105
- Other IDs
- 2019-003496-18, 2019
- Status last verified
- Mar 2024
- First submitted
- 15 Feb 2022
- Last updated
- 22 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 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 and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05254613
- Acronym / sponsor ID
- ALXN1830-HV-105
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The justification of the early termination of the trial: the study is early terminated due to the Coronavirus 2019 epidemic.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Posted 22 Mar 2024
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 effects of single ascending doses (SAD) and multiple ascending doses (MAD) of ALXN1830 administered subcutaneously (SC) to healthy adult participants.
Detailed description
This Phase 1 study will consist of 3 SAD (Cohorts 1 to 3) and 4 MAD (Cohorts 4 to 7) cohorts. Participants will be randomly assigned in a 6:2 ratio to each of the 7 cohorts to receive either single or multiple doses of ALXN1830 (n = 6 per cohort) or single or multiple doses of placebo (n = 2 per cohort).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: ALXN1830, Drug: PlaceboParticipants will receive a single SC dose of ALXN1830 or placebo (750 mg). |
| Cohort 2 | Experimental | Drug: ALXN1830, Drug: PlaceboParticipants will receive a single SC dose of ALXN1830 or placebo (1500 mg). |
| Cohort 3 | Experimental | Drug: ALXN1830, Drug: PlaceboParticipants will receive a single SC dose of ALXN1830 or placebo (2250 mg). |
| Cohort 4 | Experimental | Drug: ALXN1830, Drug: PlaceboParticipants will receive multiple SC doses of ALXN1830 or placebo (300 mg twice weekly; 8 doses total). |
| Cohort 5 | Experimental | Drug: ALXN1830, Drug: PlaceboParticipants will receive multiple SC doses of ALXN1830 or placebo (750 mg once weekly; 12 doses total). |
| Cohort 6 | Experimental | Drug: ALXN1830, Drug: PlaceboParticipants will receive multiple SC doses of ALXN1830 or placebo (1500 mg once weekly; 4 doses total). |
| Cohort 7 | Experimental | Drug: ALXN1830, Drug: PlaceboParticipants will receive multiple SC doses of ALXN1830 or placebo (2250 mg once weekly; 4 doses total). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Satisfactory medical assessment.
- Participants must have had vaccination against pneumococcus (Pneumovax 23 [PPSV23]) at least 28 days, and maximally 4 years prior to Day 1.
- Participants must have had seasonal influenza vaccination for the current season at least 28 days prior to Day 1.
- Body weight within 50 to 90 kg, inclusive, and body mass index (BMI) within the range of 18 to 24.9 kg/m^2, inclusive.
- Must be willing to follow protocol-specified contraception guidance during the study and for up to 3 months after last dose of study drug.
Key exclusion criteria (9 listed)
- Current/recurrent diseases or relevant medical history.
- Known exposure to therapeutic proteins, such as monoclonal antibodies, including marketed drugs prior to dosing.
- Participants who have prior exposure to ALXN1830.
- Exposure to more than 4 new (small molecule) investigational compounds within 12 months prior to dosing.
- Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study.
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 |
|---|---|---|
| ALXN1830ALXN1830 will be administered as SC infusion(s). | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
| PlaceboPlacebo will be administered as SC infusion(s). | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 64
A TEAE was defined as any adverse event (AE) that commences after the start of administration of study drug. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An AE was considered serious if, in the view of the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. A summary of all serious AEs and other AEs (nonserious) regardless of causality is located in 'Adverse events' Section.
4 secondary outcomes
Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To The Last Quantifiable Concentration (AUC0-t) of ALXN1830
Time frame: Predose, end of infusion, and 0.5, 2, 4, 8, and 12 hours postdose on Day 1; and Days 2 to 8
Percent Change From Baseline in Immunoglobulin G (IgG) Levels at Day 10
Time frame: Baseline, Day 10
Number of Participants With Positive Anti-Drug Antibodies (ADA)
Time frame: Baseline up to Day 64
Number of Participants With Positive Neutralizing Antibodies (NAbs)
Time frame: Baseline up to Day 64
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- CSR SynopsisLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
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 ALXN1830 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United Kingdom.
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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 22 Mar 2024. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 22 Mar 2024). 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?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline up to Day 64). 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 22 Mar 2024.