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HealthyPhase 1NCT04631562

Study of ALXN1820 in Healthy Adult Participants

A Phase 1 study testing ALXN1820 SC and ALXN1820 IV in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1820 administered subcutaneously (SC) (ALXN1820 SC) and intravenously (IV) (ALXN1820 IV). Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
ALXN1820 SC and ALXN1820 IV
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
3 sitesin 2 countries
Study dates
13 Jan 2021to 1 Sep 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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Body weight 50 to 100 kilograms (kg); body mass index 17 to 32 kg/meter squared.
  • Cohort 9 only: Japanese participants (defined as those participants whose parents and grandparents are both Japanese and who have spent less than 5 years outside of Japan).
  • Satisfactory medical assessment.
  • Must follow protocol-specified contraception guidance while on treatment and for up to 6 months after last dose.
  • Vaccination requirement:
  • Vaccination with tetravalent meningococcal conjugate vaccine at least 56 days and not more than 2 years, 6 months prior to dosing;
  • Vaccination with serogroup B meningococcal vaccine at least 56 days prior to dosing, with a booster at least 28 days prior to dosing, with at least 28 days between the first and second injections.

Who cannot join

  • Current/recurrent diseases or relevant medical history.
  • History of any Neisseria infection.
  • Hepatitis B/C, human immunodeficiency virus.
  • History of latent or active tuberculosis (TB), or positive TB test.
  • Active systemic infection within 14 days of dosing.
  • Risk of meningococcal infections due to living/working conditions.
Show all 10Show fewer
  • History of complement deficiency or complement activity below the reference range.
  • Participation in a clinical study within 90 days or 5 half lives of the investigational agent (whichever is longer) before initiation of dosing on Day 1.
  • Participation in more than 1 clinical study of a monoclonal antibody (mAb), or participation in a clinical study of a mAb within the 6 months or 5 half lives of the mAb (whichever is longer) prior to screening.
  • Acquired complement deficiencies (for example, those receiving eculizumab).

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United Kingdom2 sites

  • Research Site

    London, SE1 1YR

  • Research Site

    London, SE5 9RS

Other trials in United Kingdom

Australia1 site

  • Research Site

    Herston, 4006

Other trials in Australia

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of Subcutaneous and Intravenous ALXN1820 in Healthy Participants

This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1820 administered subcutaneously (SC) (ALXN1820 SC) and intravenously (IV) (ALXN1820 IV).

Read the detailed description

This study will include up to 10 different dosing cohorts, with each cohort consisting of 2 groups (ALXN1820 group, placebo group). Participants will be randomly assigned in a 3:1 ratio to each of these 2 groups, respectively, within all 10 cohorts, to receive either a single or multiple doses of ALXN1820 SC, a single dose of ALXN1820 IV, or a single or multiple doses of placebo.

The study will be conducted in healthy adult participants and will also include a multiple SC dose cohort in healthy participants of Japanese descent.

Conditions
Healthy
Being tested
ALXN1820 SC, ALXN1820 IV, Placebo SC, Placebo IV
Keywords
ALXN1820, Properdin, Pharmacodynamics, Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALXN1820 SCDrug

    ALXN1820 SC will be administered as a manual SC push or SC infusion via a syringe pump. Doses will range from 12.5 milligrams (mg) to a maximum of 2250 mg. Multiple dosing duration will range from 3 to 5 weeks.

  • ALXN1820 IVDrug

    ALXN1820 IV (450 mg) will be administered as an IV infusion.

  • Placebo SCDrug

    Placebo SC will be administered as a manual SC push or SC infusion via a syringe pump.

  • Placebo IVDrug

    Placebo IV will be administered as an IV infusion.

Study groups in NCT04631562
Study groupRoleWhat they receive
ALXN1820ExperimentalParticipants will receive ALXN1820 SC or ALXN1820 IV according to their assigned cohort. ALXN1820 SC will be evaluated in single and multiple ascending doses while ALXN1820 IV will be evaluated in a single dose cohort only.
Receives: Drug: ALXN1820 SC; Drug: ALXN1820 IV
PlaceboPlacebo comparatorParticipants will receive Placebo SC or Placebo IV according to their assigned cohort.
Receives: Drug: Placebo SC; Drug: Placebo IV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-related Adverse Events (TEAEs) For ALXN1820 SC And ALXN1820 IV

    An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as any AEs that commenced after the start of administration of study intervention. Serious AEs (SAEs) were defined as any untoward medical occurrence that met at least 1 of the following serious criteria: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, other medically important serious event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported AEs' Section.

    Measured: Cohorts 1 to 6: Baseline up to Day 127; Cohorts 8 to 9: Baseline up to Day 155

Secondary outcomes (12)

  1. Area Under The Concentration-time Curve (AUC) From Time 0 (Dosing) To Time Infinity (AUC0-inf) And AUC During The Dosing Interval (AUCtau) of Serum ALXN1820 For Single Dose Cohorts

    Measured: Up to 126 days following the first day of dosing

  2. Area Under The Concentration-time Curve During The Dosing Interval (AUCtau) Of Serum ALXN1820 For Multiple Dose Cohorts

    Measured: Up to 154 days following the first day of dosing

  3. Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Single Dose Cohorts

    Measured: Up to 126 days following the first day of dosing

  4. Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Multiple Dose Cohorts

    Measured: Up to 154 days following the first day of dosing

  5. Change From Baseline in Serum Concentrations Of Total Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts

    Measured: Baseline, Day 127

  6. Change From Baseline in Serum Concentrations Of Free Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts

    Measured: Baseline, Day 127

  7. Change From Baseline In Serum Concentrations of Total Properdin For ALXN1820 SC- Multiple Dose Cohorts

    Measured: Baseline, Day 155

  8. Change From Baseline In Serum Concentrations of Free Properdin For ALXN1820 SC- Multiple Dose Cohorts

    Measured: Baseline, Day 155

  9. Change From Baseline In Complement Alternative Pathway (CAP) Activity Using The Wieslab Alternative Pathway (AP) Assay For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts

    Measured: Baseline, Day 127

  10. Change From Baseline In Complement Alternative Pathway Activity Using The Wieslab Alternative Pathway Assay For ALXN1820 SC- Multiple Dose Cohorts

    Measured: Baseline, Day 155

  11. Number Of Participants With Positive Antidrug Antibodies (ADAs) To ALXN1820 SC And ALXN1820 IV

    Measured: Baseline up to Day 155

  12. Absolute Bioavailability Of ALXN1820 SC

    The absolute bioavailability was expressed as ratio and was calculated as the geometric mean for the AUC[0-inf] for SC divided by the geometric mean for the AUC[0-inf] for IV. Least square means were calculated with cohort, treatment, and sequence as the fixed effects, and participant-participant (sequence) as a random effect.

    Measured: Baseline up to Day 127

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2020
  2. Study start13 Jan 2021
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2022

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04631562
Sponsor's protocol ID
ALXN1820-HV-101
Other IDs
2021-002472-39
Status last verified
Jul 2024
First submitted
13 Nov 2020
Last updated
20 Aug 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sandhu A, Shen T, Herrero PM, Yuan CX, Qureshi S, Jiang X, Sheng Y, Gasteyger C, Dai Y. Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN1820 (Tarperprumig) in Healthy Adults: Results of a Phase I Study. Clin Transl Sci. 2025 Apr;18(4):e70190. doi: 10.1111/cts.70190.

    PubMed 40134111

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ALXN1820 SC and ALXN1820 IV in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 3 sites in 2 countries.

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 7 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 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom, Australia. 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?

Yes. Results are posted in the registry (first posted 15 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-related Adverse Events (TEAEs) For ALXN1820 SC And ALXN1820 IV (time frame: Cohorts 1 to 6: Baseline up to Day 127; Cohorts 8 to 9: Baseline up to Day 155). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04631562, which also lists 1 linked publication.

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 20 Aug 2024.

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Study of ALXN1820 in Healthy Adult Participants | AzTrials