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OpenTrials
Completed

NCT Number: NCT05047484

A Study of Multiple Doses of ALXN2050 in Healthy Adults

This was a Phase 1, placebo-controlled, randomized, double-blind (participant and investigator blind, sponsor open), multiple-ascending dose study conducted in healthy participants to demonstrate the safety and tolerability and to evaluate the pharmacokinetics and pharmacodynamics of ACH-0145228 (ALXN2050).

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Key information

Conditions

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

Auckland, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Was overtly healthy as determined by medical evaluation including detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
  • Had a body weight of at least 50 kilograms (kg) and body mass index within the range of 18 to 30 kg/meter squared (inclusive).
  • Male participants were eligible to participate if they agreed to abstinence or use of a highly effective method of contraception.
  • Female participants must have been of nonchildbearing potential.

Key Exclusion Criteria:

  • Had a history or clinically relevant evidence of current cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disorders or conditions capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
  • 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 sensitivity to any of the study interventions, or components thereof, or drug or other allergy that contraindicated participation in the study.
  • Donated blood or lost more than 500 milliliters of blood within 3 months prior to first study drug administration, or received a blood transfusion or blood products within 6 months prior to first study drug administration.
  • Current enrollment or past participation within the last 30 days before study drug administration in any clinical study involving an investigational study intervention or any other type of medical research
  • Had clinically significant laboratory abnormalities.
  • Positive urine drug screen at Screening or Day -1; was a current tobacco/nicotine user or smoker; consumed any alcohol within 72 hours before first study drug administration or had a history of regular alcohol consumption within 6 months of screening.

Treatment and study plan

ALXN2050

Drug

Powder-in-capsule (PIC).

Other names: ACH-0145228 (formerly), ACH-5228

Placebo

Drug

PIC.

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 Steady-state Plasma Concentration (Cmax,ss) Of Multiple-dose ALXN2050

    Time frame: Up to 168 hours postdose

  2. Time To Reach Maximum Steady-state Plasma Concentration (Tmax,ss) Of Multiple-dose ALXN2050

    Time frame: Up to 168 hours postdose

  3. Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Multiple-dose ALXN2050

    Time frame: Up to 168 hours postdose

  4. Maximum Plasma Concentration (Cmax) Of Single-dose ALXN2050

    Time frame: Up to 72 hours postdose

  5. Time To Reach Maximum Plasma Concentration (Tmax) Of Single-dose ALXN2050

    Time frame: Up to 72 hours postdose

  6. Area Under The Concentration-time Curve Extrapolated To Infinity (AUC0-inf) For Single-dose ALXN2050

    Time frame: Up to 72 hours postdose

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

    Time frame: Up to 14 days postdose

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

    Time frame: Up to 14 days postdose

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Collaborators

  • Achillion, a wholly owned subsidiary of Alexion

Registry information

Official study title

A Randomized, Double-Blind, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACH-0145228 in Healthy Participants

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 17, 2021
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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