HealthyPhase 1NCT04730804
A Study of ALXN1830 in Healthy Adult Participants
A Phase 1 study testing ALXN1830 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 2 sites in New Zealand.
Trial summary
This trial will study the effects of single and multiple doses of ALXN1830 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
- 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
- 34 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 17 Mar 2021to 4 Jan 2022
- 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
- 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 60 to 90 kilograms (kg), inclusive, and body mass index within 18 to 30 kg/meter squared, inclusive.
- Must be willing to follow protocol-specified contraception guidance during the study and for 3 months after last dose of study drug.
Who cannot join
- Current/recurrent diseases or relevant medical history.
- Known exposure to investigational or marketed therapeutic proteins, such as monoclonal antibodies, fusion proteins, bispecific molecules, or antibody drug conjugates, within 60 days or 5 half-lives (whichever is longer) prior to dosing.
- Participants who have prior exposure to ALXN1830.
- Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study.
- Participants with hepatitis B or C, or human immunodeficiency virus.
- 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
2 sites in 1 country.
New Zealand2 sites
Clinical Trial Site
Auckland
Research Site
Grafton, 1010
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 trial will study the effects of single and multiple doses of ALXN1830 in healthy adult participants.
Read the detailed description
This is a Phase 1 study in healthy adult participants. The study will consist of 2 single ascending dose (Cohorts 1 and 2) and 4 multiple ascending dose cohorts (Cohorts 3 to 6). Participants will be randomly assigned to each of the 6 cohorts to receive either single or multiple doses of ALXN1830 subcutaneous (SC) or single or multiple doses of placebo SC. Cohort 6 will enroll only healthy participants of Japanese descent who will be dosed according to the highest tolerated dose (HTD) established in the non-Japanese cohorts.
- Conditions
- Healthy
- Being tested
- ALXN1830, Placebo
- Keywords
- ALXN1830, Autoimmune Disease, Pharmacokinetics, Pharmacodynamics
- Medical subject headings
- Autoimmune Diseases
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
Also called Normal Saline
Placebo will be administered as SC infusion(s).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: ALXN1830 Single Dose 1/Placebo | Experimental | Participants will receive a single SC dose of ALXN1830 or placebo. Receives: Drug: ALXN1830; Drug: Placebo |
| Cohort 2: ALXN1830 Single Dose 2/Placebo | Experimental | Participants will receive a single SC dose of ALXN1830 or placebo. Receives: Drug: ALXN1830; Drug: Placebo |
| Cohort 3: ALXN1830 Multiple Dose 1/Placebo | Experimental | Participants will receive multiple SC doses of ALXN1830 or placebo. Receives: Drug: ALXN1830; Drug: Placebo |
| Cohort 4: ALXN1830 Multiple Dose 2/Placebo | Experimental | Participants will receive multiple SC doses of ALXN1830 or placebo. Receives: Drug: ALXN1830; Drug: Placebo |
| Cohort 5: ALXN1830 Multiple Dose 3/Placebo | Experimental | Participants will receive multiple SC doses of ALXN1830 or placebo. Receives: Drug: ALXN1830; Drug: Placebo |
| Cohort 6: ALXN1830 /Placebo in Japanese Population | Experimental | Japanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo. 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)
An AE was any untoward medical occurrence in a participant administered the study drug and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with a start date or time on or after the first dose of the study intervention. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Day 1 (postdose) through follow-up (up to approximately 141 days)
Secondary outcomes (7)
Single-Dose Cohorts: Area Under the Serum Concentration-time Curve From Time 0 (Dosing) To Time Infinity (AUC0-inf) of ALXN1830
Serum total drug concentrations were measured using a validated liquid chromatography/mass spectrometry (LC/MS) assay.
Measured: Day 1 (predose) up to Day 64 (postdose)
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 1
Serum total drug concentrations were measured using a validated LC/MS assay.
Measured: Day 1 (predose up to 12 hours postdose)
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 22
Serum total drug concentrations were measured using a validated LC/MS assay.
Measured: Day 22 (predose up to 12 hours postdose)
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 78
Serum total drug concentrations were measured using a validated LC/MS assay.
Measured: Day 78 (predose up to 12 hours postdose)
Change From Baseline in Serum Immunoglobulin G (IgG) at Early Termination Visit (up to Day 141)
Serum concentration of IgG was measured using validated nephelometric assays.
Measured: Baseline, early termination visit (up to Day 141)
Percent FcRN Receptor Occupancy at Day 120
Measured: Day 120
Number of Participants With Antidrug Antibodies (ADA) and Neutralizing Antibodies (NAb) to ALXN1830
Measured: Day 1 (postdose) through follow-up (up to approximately 141 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start17 Mar 2021
- Primary completion14 Dec 2021
- Study completion4 Jan 2022
Why it stopped: Sponsor decision to terminate program
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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730804
- Sponsor's protocol ID
- ALXN1830-HV-108
- Status last verified
- Sep 2024
- First submitted
- 26 Jan 2021
- Last updated
- 19 Sep 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 19 Sep 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
- NCT04730804
- Acronym / sponsor ID
- ALXN1830-HV-108
- Conditions
- Healthy
- Keywords
- ALXN1830, Autoimmune Disease, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to terminate program
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 4 Jan 2022 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will study the effects of single and multiple doses of ALXN1830 in healthy adult participants.
Detailed description
This is a Phase 1 study in healthy adult participants. The study will consist of 2 single ascending dose (Cohorts 1 and 2) and 4 multiple ascending dose cohorts (Cohorts 3 to 6). Participants will be randomly assigned to each of the 6 cohorts to receive either single or multiple doses of ALXN1830 subcutaneous (SC) or single or multiple doses of placebo SC. Cohort 6 will enroll only healthy participants of Japanese descent who will be dosed according to the highest tolerated dose (HTD) established in the non-Japanese cohorts.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: ALXN1830 Single Dose 1/Placebo | Experimental | Drug: ALXN1830, Drug: PlaceboParticipants will receive a single SC dose of ALXN1830 or placebo. |
| Cohort 2: ALXN1830 Single Dose 2/Placebo | Experimental | Drug: ALXN1830, Drug: PlaceboParticipants will receive a single SC dose of ALXN1830 or placebo. |
| Cohort 3: ALXN1830 Multiple Dose 1/Placebo | Experimental | Drug: ALXN1830, Drug: PlaceboParticipants will receive multiple SC doses of ALXN1830 or placebo. |
| Cohort 4: ALXN1830 Multiple Dose 2/Placebo | Experimental | Drug: ALXN1830, Drug: PlaceboParticipants will receive multiple SC doses of ALXN1830 or placebo. |
| Cohort 5: ALXN1830 Multiple Dose 3/Placebo | Experimental | Drug: ALXN1830, Drug: PlaceboParticipants will receive multiple SC doses of ALXN1830 or placebo. |
| Cohort 6: ALXN1830 /Placebo in Japanese Population | Experimental | Drug: ALXN1830, Drug: PlaceboJapanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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 60 to 90 kilograms (kg), inclusive, and body mass index within 18 to 30 kg/meter squared, inclusive.
- Must be willing to follow protocol-specified contraception guidance during the study and for 3 months after last dose of study drug.
Key exclusion criteria (6 listed)
- Current/recurrent diseases or relevant medical history.
- Known exposure to investigational or marketed therapeutic proteins, such as monoclonal antibodies, fusion proteins, bispecific molecules, or antibody drug conjugates, within 60 days or 5 half-lives (whichever is longer) prior to dosing.
- Participants who have prior exposure to ALXN1830.
- Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study.
- Participants with hepatitis B or C, or human immunodeficiency virus.
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: ALXN1830 Single Dose 1/Placebo, Cohort 2: ALXN1830 Single Dose 2/Placebo, Cohort 3: ALXN1830 Multiple Dose 1/Placebo, Cohort 4: ALXN1830 Multiple Dose 2/Placebo, Cohort 5: ALXN1830 Multiple Dose 3/Placebo, Cohort 6: ALXN1830 /Placebo in Japanese Population |
| PlaceboAlso: Normal SalinePlacebo will be administered as SC infusion(s). | Drug | Cohort 1: ALXN1830 Single Dose 1/Placebo, Cohort 2: ALXN1830 Single Dose 2/Placebo, Cohort 3: ALXN1830 Multiple Dose 1/Placebo, Cohort 4: ALXN1830 Multiple Dose 2/Placebo, Cohort 5: ALXN1830 Multiple Dose 3/Placebo, Cohort 6: ALXN1830 /Placebo in Japanese Population |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 (postdose) through follow-up (up to approximately 141 days)
An AE was any untoward medical occurrence in a participant administered the study drug and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with a start date or time on or after the first dose of the study intervention. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
7 secondary outcomes
Single-Dose Cohorts: Area Under the Serum Concentration-time Curve From Time 0 (Dosing) To Time Infinity (AUC0-inf) of ALXN1830
Time frame: Day 1 (predose) up to Day 64 (postdose)
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 1
Time frame: Day 1 (predose up to 12 hours postdose)
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 22
Time frame: Day 22 (predose up to 12 hours postdose)
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 78
Time frame: Day 78 (predose up to 12 hours postdose)
Change From Baseline in Serum Immunoglobulin G (IgG) at Early Termination Visit (up to Day 141)
Time frame: Baseline, early termination visit (up to Day 141)
Percent FcRN Receptor Occupancy at Day 120
Time frame: Day 120
Number of Participants With Antidrug Antibodies (ADA) and Neutralizing Antibodies (NAb) to ALXN1830
Time frame: Day 1 (postdose) through follow-up (up to approximately 141 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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 ALXN1830 in people with Healthy, 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 5 inclusion and 6 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 19 Sep 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. 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 19 Sep 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: Day 1 (postdose) through follow-up (up to approximately 141 days)). 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 19 Sep 2024.