A Study of Single-dose ALXN2050 in Healthy Adults

Sponsor
Alexion Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT05047458
Collaborator
Achillion, a wholly owned subsidiary of Alexion (Industry)
28
1
3
4.5
6.3

Study Details

Study Description

Brief Summary

This was a phase 1, first-in-human, single-center, randomized, double-blind (participants and investigator blind, sponsor open) placebo-controlled, single-ascending dose study of ACH-0145228 (ALXN2050) conducted in healthy adult participants.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACH-0145228 in Healthy Volunteers
Actual Study Start Date :
Nov 28, 2017
Actual Primary Completion Date :
Apr 13, 2018
Actual Study Completion Date :
Apr 13, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1: 40 mg ALXN2050/Placebo

Participants randomized to receive ALXN2050 or placebo on Day 1.

Drug: ALXN2050
Powder-in-capsule (PIC).
Other Names:
  • ACH-0145228 (formerly)
  • ACH-5228
  • Drug: Placebo
    PIC.

    Experimental: Cohort 2: 80 mg ALXN2050/Placebo

    Participants randomized to receive ALXN2050 or placebo on Day 1.

    Drug: ALXN2050
    Powder-in-capsule (PIC).
    Other Names:
  • ACH-0145228 (formerly)
  • ACH-5228
  • Drug: Placebo
    PIC.

    Experimental: Cohort 3: 120 mg ALXN2050/Placebo

    Participants randomized to receive ALXN2050 or placebo on Day 1.

    Drug: ALXN2050
    Powder-in-capsule (PIC).
    Other Names:
  • ACH-0145228 (formerly)
  • ACH-5228
  • Drug: Placebo
    PIC.

    Outcome Measures

    Primary Outcome Measures

    1. Number Of Participants Experiencing Serious Adverse Events [Day 1 through Day 42]

    2. Number Of Participants Experiencing Grade 3 Or 4 Adverse Events (AEs) [Day 1 through Day 42]

    3. Number Of Participants Experiencing AEs Leading To Discontinuation From The Study [Day 1 through Day 42]

    4. Number Of Participants Experiencing Grade 3 Or 4 Laboratory Abnormalities [Day 1 through Day 42]

    5. Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities [Day 1 through Day 42]

    Secondary Outcome Measures

    1. Maximum Plasma Concentration (Cmax) Of ALXN2050 [Up to 144 hours postdose]

    2. Time To Reach The Maximum Plasma Concentration (Tmax) Of ALXN2050 [Up to 144 hours postdose]

    3. Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of ALXN2050 [Up to 144 hours postdose]

    4. Alternative Pathway (AP) Activity As Measured By Wieslab Assay [Up to 144 hours postdose]

    5. Plasma Bb Fragment Of Complement Factor B Concentration Over Time [Up to 144 hours postdose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Key Inclusion Criteria:
    • Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.

    • Had a body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.

    • Female participant of nonchildbearing potential.

    • Male participant agreed to abstinence or use of a highly effective form of contraception.

    Key Exclusion Criteria:
    • Had a history or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.

    • Had any condition possibly affecting drug absorption.

    • Had a body temperature greater than or equal to 38°Celsius on Day -1 or Day 1, Hour 0; had a history of febrile illness, or other evidence of infection, within 14 days prior to first study drug administration.

    • Had a positive urine drug screen at Screening or Day -1; was a current tobacco/nicotine user or smoker; had consumed any alcohol within 72 hours before first study drug administration or had a history of regular alcohol consumption within 6 months of Screening.

    • Had participated in a clinical study within 30 days prior to first study drug administration

    • Had clinically significant laboratory abnormalities,

    • Had donated blood or lost more than 500 milliliters of blood within 3 months prior to first study drug administration; had received a blood transfusion or blood products within 6 months prior to first study drug administration.

    • Had a clinically significant history of drug allergy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Trial Site Auckland New Zealand

    Sponsors and Collaborators

    • Alexion Pharmaceuticals
    • Achillion, a wholly owned subsidiary of Alexion

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alexion Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05047458
    Other Study ID Numbers:
    • ACH228-001
    • ACTRN12617001521314
    • U1111-1203-1371
    First Posted:
    Sep 17, 2021
    Last Update Posted:
    Sep 17, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Alexion Pharmaceuticals

    Study Results

    No Results Posted as of Sep 17, 2021