A Study of Single-dose ALXN2050 in Healthy Adults

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ALXN2050; Drug: Placebo

• Registration Number: NCT05047458
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-28
• Primary Completion: 2018-04-13
• Study Completion: 2018-04-13
• Status Verified: 2021-09
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-09
• Last Update Submitted: 2021-09-09
• Study First Posted: 2021-09-17
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2: 80 mg ALXN2050/Placebo	Placebo	Participants randomized to receive ALXN2050 or placebo on Day 1.
Cohort 3: 120 mg ALXN2050/Placebo	ALXN2050	Participants randomized to receive ALXN2050 or placebo on Day 1.
Cohort 3: 120 mg ALXN2050/Placebo	Placebo	Participants randomized to receive ALXN2050 or placebo on Day 1.
Cohort 1: 40 mg ALXN2050/Placebo	ALXN2050	Participants randomized to receive ALXN2050 or placebo on Day 1.
Cohort 1: 40 mg ALXN2050/Placebo	Placebo	Participants randomized to receive ALXN2050 or placebo on Day 1.
Cohort 2: 80 mg ALXN2050/Placebo	ALXN2050	Participants randomized to receive ALXN2050 or placebo on Day 1.

Primary Outcome Measures

Name	Time	Method
Number Of Participants Experiencing Serious Adverse Events	Day 1 through Day 42
Number Of Participants Experiencing Treatment-emergent Vital Signs, Physical Examination Results, And Electrocardiogram (ECG) Abnormalities	Day 1 through Day 42
Number Of Participants Experiencing Grade 3 Or 4 Adverse Events (AEs)	Day 1 through Day 42
Number Of Participants Experiencing AEs Leading To Discontinuation From The Study	Day 1 through Day 42
Number Of Participants Experiencing Grade 3 Or 4 Laboratory Abnormalities	Day 1 through Day 42

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) Of ALXN2050	Up to 144 hours postdose
Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of ALXN2050	Up to 144 hours postdose
Alternative Pathway (AP) Activity As Measured By Wieslab Assay	Up to 144 hours postdose
Plasma Bb Fragment Of Complement Factor B Concentration Over Time	Up to 144 hours postdose
Time To Reach The Maximum Plasma Concentration (Tmax) Of ALXN2050	Up to 144 hours postdose

Trial Locations

Locations (1)

Clinical Trial Site; 🇳🇿 Auckland, New Zealand