HealthyPhase 1NCT05501717
Safety, PK/PD, and Immunogenicity Study of SC ALXN2030 in Healthy Participants
A Phase 1 study testing ALXN2030 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United Kingdom.
Trial summary
The primary purpose of this study is to assess the safety and tolerability of single ascending doses of ALXN2030 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ALXN2030
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Aug 2022to 14 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants
- QTcF ≤ 450 msec at Screening and on admission (ie, on Day -1).
- Participants of Japanese descent are defined as: First generation (born to 2 Japanese parents and 4 Japanese grandparents).
- Participants of Japanese descent must be between 20 and 60 years of age.
- BMI within the range 18-32kg/m2 (inclusive) at Screening.
Who cannot join
- Current or recurrent disease
- Current or relevant history of physical or psychiatric illness.
- Any other significant disease or disorder that, in the opinion of the Investigator, may put the participant at risk.
- Female participants who are pregnant or breastfeeding.
- Major surgery or hospitalization within 90 days prior to dosing on Day1.
- History of allergy or hypersensitivity to an oligonucleotide or GalNAc moiety or any excipients of ALXN2030.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Subcutaneous ALXN2030 in Healthy Participants
The primary purpose of this study is to assess the safety and tolerability of single ascending doses of ALXN2030 in healthy participants.
Read the detailed description
Approximately 48 healthy adult participants (36 participants will be on ALXN2030 and 12 participants will be on placebo) are expected to be enrolled.
- Conditions
- Healthy
- Being tested
- ALXN2030, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN2030Drug
ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.
PlaceboDrug
Placebo will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.
| Study group | Role | What they receive |
|---|---|---|
| ALXN2030 Dose A | Experimental | ALXN2030 will be administered as a single dose. Receives: Drug: ALXN2030 |
| ALXN2030 Dose B | Experimental | ALXN2030 will be administered as a single dose. Receives: Drug: ALXN2030 |
| ALXN2030 Dose C | Experimental | ALXN2030 will be administered as a single dose. Receives: Drug: ALXN2030 |
| ALXN2030 Dose D | Experimental | ALXN2030 will be administered as a single dose. Receives: Drug: ALXN2030 |
| ALXN2030 Dose E | Experimental | ALXN2030 will be administered as a single dose. Receives: Drug: ALXN2030 |
| Placebo | Placebo comparator | Placebo will be administered as a single dose. Receives: 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) and Treatment-Emergent Serious Adverse Events (TESAEs)
Measured: Day 1 through through study completion, an average of 1 year
Secondary outcomes (6)
Maximum Observed Plasma Concentration (Cmax)
Measured: Days 1 (predose; end of infusion (EOI); and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127
Time to Maximum Observed Plasma Concentration (Tmax)
Measured: Days 1 (predose; EOI; and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127
Area Under the Plasma Concentration Versus Time Curve From Time 0 (Dosing) to the Last Quantifiable Concentration (AUCt)
Measured: Days 1 (predose; EOI; and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127
Change from Baseline in Plasma Concentration of Complement Component 3 (C3) Protein
Measured: Baseline (Day 1) and study completion, an average of 1 year
Change from Baseline in Serum Complement Functional Activity
Measured: Baseline (Day 1) and Day 127
Number of Participants With Treatment-Emergent Antidrug Antibodies (ADAs)
Measured: Days 1 through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start16 Aug 2022
- Primary completion9 Oct 2025
- Study completion14 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
- NCT05501717
- Sponsor's protocol ID
- ALXN2030-HV-101
- Status last verified
- Apr 2026
- First submitted
- 12 Aug 2022
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. 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 Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Subcutaneous ALXN2030 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05501717
- Acronym / sponsor ID
- ALXN2030-HV-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 9 Oct 2025 (actual)
- Study completion
- 14 Oct 2026 (estimated)
- First posted
- 15 Aug 2022 (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.
The primary purpose of this study is to assess the safety and tolerability of single ascending doses of ALXN2030 in healthy participants.
Detailed description
Approximately 48 healthy adult participants (36 participants will be on ALXN2030 and 12 participants will be on placebo) are expected to be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ALXN2030 Dose A | Experimental | Drug: ALXN2030ALXN2030 will be administered as a single dose. |
| ALXN2030 Dose B | Experimental | Drug: ALXN2030ALXN2030 will be administered as a single dose. |
| ALXN2030 Dose C | Experimental | Drug: ALXN2030ALXN2030 will be administered as a single dose. |
| ALXN2030 Dose D | Experimental | Drug: ALXN2030ALXN2030 will be administered as a single dose. |
| ALXN2030 Dose E | Experimental | Drug: ALXN2030ALXN2030 will be administered as a single dose. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered as a single dose. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy participants
- QTcF ≤ 450 msec at Screening and on admission (ie, on Day -1).
- Participants of Japanese descent are defined as: First generation (born to 2 Japanese parents and 4 Japanese grandparents).
- Participants of Japanese descent must be between 20 and 60 years of age.
- BMI within the range 18-32kg/m2 (inclusive) at Screening.
Key exclusion criteria (6 listed)
- Current or recurrent disease
- Current or relevant history of physical or psychiatric illness.
- Any other significant disease or disorder that, in the opinion of the Investigator, may put the participant at risk.
- Female participants who are pregnant or breastfeeding.
- Major surgery or hospitalization within 90 days prior to dosing on Day1.
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 |
|---|---|---|
| ALXN2030ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump. | Drug | ALXN2030 Dose A, ALXN2030 Dose B, ALXN2030 Dose C, ALXN2030 Dose D, ALXN2030 Dose E |
| PlaceboPlacebo will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump. | Drug | Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 through through study completion, an average of 1 year
6 secondary outcomes
Maximum Observed Plasma Concentration (Cmax)
Time frame: Days 1 (predose; end of infusion (EOI); and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127
Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: Days 1 (predose; EOI; and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127
Area Under the Plasma Concentration Versus Time Curve From Time 0 (Dosing) to the Last Quantifiable Concentration (AUCt)
Time frame: Days 1 (predose; EOI; and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127
Change from Baseline in Plasma Concentration of Complement Component 3 (C3) Protein
Time frame: Baseline (Day 1) and study completion, an average of 1 year
Change from Baseline in Serum Complement Functional Activity
Time frame: Baseline (Day 1) and Day 127
Number of Participants With Treatment-Emergent Antidrug Antibodies (ADAs)
Time frame: Days 1 through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
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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 ALXN2030 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 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: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
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) and Treatment-Emergent Serious Adverse Events (TESAEs) (time frame: Day 1 through through study completion, an average of 1 year). 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 9 Apr 2026.