A Study of Multiple Doses of ALXN2050 in Healthy Adults

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047484
• Other study ID #: ACH228-002
• Status: Completed
• Phase: Phase 1
• Start date: January 7, 2019
• Est. completion date: July 23, 2019

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, 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 23, 2019
• Est. primary completion date: July 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

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 Steady-state Plasma Concentration (Cmax,ss) Of Multiple-dose ALXN2050		Up to 168 hours postdose
Secondary	Time To Reach Maximum Steady-state Plasma Concentration (Tmax,ss) Of Multiple-dose ALXN2050		Up to 168 hours postdose
Secondary	Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Multiple-dose ALXN2050		Up to 168 hours postdose
Secondary	Maximum Plasma Concentration (Cmax) Of Single-dose ALXN2050		Up to 72 hours postdose
Secondary	Time To Reach Maximum Plasma Concentration (Tmax) Of Single-dose ALXN2050		Up to 72 hours postdose
Secondary	Area Under The Concentration-time Curve Extrapolated To Infinity (AUC0-inf) For Single-dose ALXN2050		Up to 72 hours postdose
Secondary	Alternative Pathway (AP) Activity As Measured By Wieslab Assay		Up to 14 days postdose
Secondary	Plasma Bb Fragment Of Complement Factor B Concentration Over Time		Up to 14 days postdose