A Study of ALXN1830 in Healthy Adult Participants

Sponsor
Alexion Pharmaceuticals (Industry)
Overall Status
Suspended
CT.gov ID
NCT04730804
Collaborator
Syneos Health (Other)
48
Enrollment
1
Location
6
Arms
9.5
Anticipated Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial will study the effects of single and multiple doses of ALXN1830 in healthy adult participants.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

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

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants
Actual Study Start Date :
Mar 17, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Cohort 1: ALXN1830 Single Dose 1/Placebo

Participants will receive a single SC dose of ALXN1830 or placebo.

Drug: ALXN1830
ALXN1830 will be administered as SC infusion(s).

Drug: Placebo
Placebo will be administered as SC infusion(s).
Other Names:
  • Normal Saline
  • Experimental: Cohort 2: ALXN1830 Single Dose 2/Placebo

    Participants will receive a single SC dose of ALXN1830 or placebo.

    Drug: ALXN1830
    ALXN1830 will be administered as SC infusion(s).

    Drug: Placebo
    Placebo will be administered as SC infusion(s).
    Other Names:
  • Normal Saline
  • Experimental: Cohort 3: ALXN1830 Multiple Dose 1/Placebo

    Participants will receive multiple SC doses of ALXN1830 or placebo.

    Drug: ALXN1830
    ALXN1830 will be administered as SC infusion(s).

    Drug: Placebo
    Placebo will be administered as SC infusion(s).
    Other Names:
  • Normal Saline
  • Experimental: Cohort 4: ALXN1830 Multiple Dose 2/Placebo

    Participants will receive multiple SC doses of ALXN1830 or placebo.

    Drug: ALXN1830
    ALXN1830 will be administered as SC infusion(s).

    Drug: Placebo
    Placebo will be administered as SC infusion(s).
    Other Names:
  • Normal Saline
  • Experimental: Cohort 5: ALXN1830 Multiple Dose 3/Placebo

    Participants will receive multiple SC doses of ALXN1830 or placebo.

    Drug: ALXN1830
    ALXN1830 will be administered as SC infusion(s).

    Drug: Placebo
    Placebo will be administered as SC infusion(s).
    Other Names:
  • Normal Saline
  • Experimental: Cohort 6: ALXN1830 /Placebo in Japanese Population

    Japanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo.

    Drug: ALXN1830
    ALXN1830 will be administered as SC infusion(s).

    Drug: Placebo
    Placebo will be administered as SC infusion(s).
    Other Names:
  • Normal Saline
  • Outcome Measures

    Primary Outcome Measures

    1. Number Of Participants With Treatment-emergent Adverse Events [Day 1 (postdose) through follow-up (up to 63 [+/- 1] days after last study drug administration)]

    Secondary Outcome Measures

    1. Area Under The Concentration-time Curve From Time 0 (Dosing) To Time Infinity (AUC0-inf) Of Serum ALXN1830 For Single And Multiple Doses [Up to 141 days postdose]

    2. Change From Baseline In Serum Immunoglobulin G (IgG) For Single And Multiple Doses Of ALXN1830 [Up to 141 days postdose]

    3. Comparison Of Incidences Of Treatment-emergent Adverse Events Between Healthy Non-Japanese Participants And Participants Of Japanese Descent For Multiple HTDs Of ALXN1830 [Day 1 (postdose) through follow-up (up to 63 [+/- 1] days after last study drug administration)]

    4. Comparison Of AUC0-inf Between Healthy Non-Japanese Participants And Participants Of Japanese Descent For Multiple HTDs Of ALXN1830 [Up to 141 days postdose]

    5. Comparison Of IgG Levels Between Healthy Non-Japanese Participants And Participants Of Japanese Descent For Multiple HTDs Of ALXN1830 [Up to 141 days postdose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 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.

    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Clinical Trial SiteAucklandNew Zealand

    Sponsors and Collaborators

    • Alexion Pharmaceuticals
    • Syneos Health

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alexion Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04730804
    Other Study ID Numbers:
    • ALXN1830-HV-108
    • 2020-001081-11
    First Posted:
    Jan 29, 2021
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Alexion Pharmaceuticals

    Study Results

    No Results Posted as of Nov 18, 2021