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OpenTrials
Completed

NCT Number: NCT05047458

A Study of Single-dose ALXN2050 in Healthy Adults

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.

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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:

  • 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.

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 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

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Collaborators

  • Achillion, a wholly owned subsidiary of Alexion

Registry information

Official study title

A Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACH-0145228 in Healthy Volunteers

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
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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