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CompletedNCT05047458Updated Sep 17, 2021

A Study of Single-dose ALXN2050 in Healthy Adults

A Phase 1 interventional study of ALXN2050 and Placebo in Healthy, sponsored by Alexion Pharmaceuticals, Inc.. Completed at 1 site in New Zealand. Open to participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-17.

Sponsored by Alexion Pharmaceuticals, Inc. · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Registered 3 years 9 months after the study started (first participant enrolled Nov 2017, registered Sep 2021).
Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
25 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • Factor D Inhibitor
  • Complement
  • ALXN2050
  • ACH-0145228
  • Pharmacokinetics
  • Pharmacodynamics
  • Safety
03

In context

Lead sponsor

Alexion Pharmaceuticals, Inc. is the lead sponsor of 249 studies on the registry; 25 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 70 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Cohort 1: 40 mg ALXN2050/Placebo

    Participants randomized to receive ALXN2050 or placebo on Day 1.

    Drug: ALXN2050 · Drug: Placebo

  • Experimental
    Cohort 2: 80 mg ALXN2050/Placebo

    Participants randomized to receive ALXN2050 or placebo on Day 1.

    Drug: ALXN2050 · Drug: Placebo

  • Experimental
    Cohort 3: 120 mg ALXN2050/Placebo

    Participants randomized to receive ALXN2050 or placebo on Day 1.

    Drug: ALXN2050 · Drug: Placebo

Interventions

  • DrugALXN2050

    Powder-in-capsule (PIC).

    Also known as: ACH-0145228 (formerly), ACH-5228

  • DrugPlacebo

    PIC.

06

What researchers measure

Primary outcomes

  1. Number Of Participants Experiencing Serious Adverse Events

    Time frame: Day 1 through Day 42

  2. Number Of Participants Experiencing Grade 3 Or 4 Adverse Events (AEs)

    Time frame: Day 1 through Day 42

  3. Number Of Participants Experiencing AEs Leading To Discontinuation From The Study

    Time frame: Day 1 through Day 42

  4. Number Of Participants Experiencing Grade 3 Or 4 Laboratory Abnormalities

    Time frame: Day 1 through Day 42

  5. Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities

    Time frame: Day 1 through Day 42

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) Of ALXN2050

    Time frame: Up to 144 hours postdose

  2. Time To Reach The Maximum Plasma Concentration (Tmax) Of ALXN2050

    Time frame: Up to 144 hours postdose

  3. Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of ALXN2050

    Time frame: Up to 144 hours postdose

  4. Alternative Pathway (AP) Activity As Measured By Wieslab Assay

    Time frame: Up to 144 hours postdose

  5. Plasma Bb Fragment Of Complement Factor B Concentration Over Time

    Time frame: Up to 144 hours postdose

07

Study locations

1 site
  • Clinical Trial Site
    Auckland, New Zealand
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05047458
Lead sponsor
Alexion Pharmaceuticals, Inc.
Collaborators
Achillion, a wholly owned subsidiary of Alexion
Responsible party
Sponsor
First posted
Sep 17, 2021
Start date
Nov 28, 2017
Primary completion
Apr 13, 2018
Completion
Apr 13, 2018
Last update
Sep 17, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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