Clinical trial NCT04952545: Study of ALXN2050 in Healthy Adult Participants of Japanese Descent
Official title: A Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of ALXN2050 in Healthy Participants of Japanese Descent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ALXN2050
Pharmacokinetics
Pharmacodynamics
Japanese Descent
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase 1 bridging study being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALXN2050 after both single- and multiple-dosing in healthy participants of Japanese descent.


Eligibility criteria: Key Inclusion Criteria:

* Medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead electrocardiogram, screening clinical laboratory profiles.
* Participants must be of Japanese descent defined as:

  * First generation (born to 2 Japanese parents and 4 Japanese grandparents);
  * Born in Japan, and not have lived outside Japan for greater than 5 years;
  * Lifestyle, including diet, must not have significantly changed since leaving Japan.
* Participants must be able to speak, read, and understand the Japanese and English languages.
* Body mass index within the range 18.5 to 30.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at Screening.

Key Exclusion Criteria:

* History of any medical or psychiatric condition or disease that, in the opinion of the Investigator or designee, might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
* History of significant multiple and/or severe allergies.
* Any previous procedure that could alter absorption or excretion of orally administered drugs.
* Participation in another investigational drug or investigational device study within 5 half-lives (if known) or 30 days prior to the first dose of study intervention, whichever is longer.
* Body temperature ≥ 38.0°Celcius, at Screening or prior to the first dose of study intervention.
* History of drug or alcohol abuse within 2 years prior to the first dose of study intervention or positive drugs-of-abuse or alcohol screen at Screening or Day -1; current tobacco/nicotine users or smokers or a positive cotinine test at Screening.
* Donation of whole blood from 3 months prior to the first dose of study intervention, or of plasma from 30 days prior to the first dose of study intervention; receipt of blood products within 6 months prior to the first dose of study intervention.

Primary outcomes:
measure: Number Of Participants With Treatment-emergent Adverse Events
timeFrame: Day 1 (after first dose) through follow-up (7 +/- 2 days after final dose)
measure: Area Under The Concentration-time Curve From Time Zero To Infinity (AUCinf) For Single-dose ALXN2050
timeFrame: Up to 72 hours postdose
measure: Maximum Plasma Concentration (Cmax) For Single-dose ALXN2050
timeFrame: Up to 72 hours postdose
measure: Time To Maximum Plasma Concentration (Tmax) For Single-dose ALXN2050
timeFrame: Up to 72 hours postdose
measure: Area Under The Concentration-time Curve From Time Zero To The 12-hour Time Point (AUC0-12) For Multiple-dose ALXN2050
timeFrame: Up to 72 hours postdose
measure: Cmax For Multiple-dose ALXN2050
timeFrame: Up to 72 hours postdose
measure: Tmax For Multiple-dose ALXN2050
timeFrame: Up to 72 hours postdose
Secondary outcomes:
measure: Alternative Pathway Activity As Measured By Wieslab Assay
timeFrame: Up to 72 hours postdose
measure: Complement Factor B Fraction b Levels
timeFrame: Up to 72 hours postdose
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Clinical Trial Site
state: Arizona
Study officials:
References: