A Study of Single-dose ALXN2050 in Healthy Adults

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047458
• Other study ID #: ACH228-001
• Secondary ID: ACTRN12617001521
• Status: Completed
• Phase: Phase 1
• Start date: November 28, 2017
• Est. completion date: April 13, 2018

Study information

• Verified date: September 2021
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 13, 2018
• Est. primary completion date: April 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ALXN2050
Powder-in-capsule (PIC).
• Placebo
PIC.

Locations

Country	Name	City	State
New Zealand	Clinical Trial Site	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals	Achillion, a wholly owned subsidiary of Alexion

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number Of Participants Experiencing Serious Adverse Events		Day 1 through Day 42
Primary	Number Of Participants Experiencing Grade 3 Or 4 Adverse Events (AEs)		Day 1 through Day 42
Primary	Number Of Participants Experiencing AEs Leading To Discontinuation From The Study		Day 1 through Day 42
Primary	Number Of Participants Experiencing Grade 3 Or 4 Laboratory Abnormalities		Day 1 through Day 42
Primary	Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities		Day 1 through Day 42
Secondary	Maximum Plasma Concentration (Cmax) Of ALXN2050		Up to 144 hours postdose
Secondary	Time To Reach The Maximum Plasma Concentration (Tmax) Of ALXN2050		Up to 144 hours postdose
Secondary	Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of ALXN2050		Up to 144 hours postdose
Secondary	Alternative Pathway (AP) Activity As Measured By Wieslab Assay		Up to 144 hours postdose
Secondary	Plasma Bb Fragment Of Complement Factor B Concentration Over Time		Up to 144 hours postdose