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Monoclonal Antibodies

ALXN2050 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Alexion
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 24, 48, and 72 hours postdose
Awards & highlights

Study Summary

This trial will study how well a new medication works in people with kidney problems in order to provide dosing recommendations.

Eligible Conditions
  • Healthy Subjects
  • Kidney Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 24, 48, and 72 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 24, 48, and 72 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under The Concentration-time Curve Calculated To The Last Observable Concentration At Time t (AUCt) Of Plasma ALXN2050 After Steady-state
Area Under The Concentration-time Curve From Time 0 To The 12-hour Time Point (AUC0-12) Of Plasma ALXN2050 After Steady-state
Maximum (Peak) Steady-state Plasma Concentration (Cmax,ss) Of Plasma ALXN2050
+1 more
Secondary outcome measures
Change From Baseline In Complement Alternative Pathway Activity
Change From Baseline In Complement Factor D Concentration At 24, 48, And 72 Hours Postdose
Change From Baseline In Plasma b Fragment Of Complement Factor B Concentration
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4: Healthy ControlExperimental Treatment1 Intervention
Participants will receive ALXN2050.
Group II: Cohort 3: Mild Impaired Renal FunctionExperimental Treatment1 Intervention
Participants will receive ALXN2050.
Group III: Cohort 2: Moderate Impaired Renal FunctionExperimental Treatment1 Intervention
Participants will receive ALXN2050.
Group IV: Cohort 1: Severe Impaired Renal FunctionExperimental Treatment1 Intervention
Participants will receive ALXN2050.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALXN2050
2021
Completed Phase 1
~250

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AlexionLead Sponsor
246 Previous Clinical Trials
39,222 Total Patients Enrolled
Alexion Pharmaceuticals, Inc.Lead Sponsor
252 Previous Clinical Trials
41,097 Total Patients Enrolled
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,368 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of ALXN2050 in Participants With Renal Impairment
2021. "Study of ALXN2050 in Participants With Renal Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04623710.
~11 spots leftby Apr 2025
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