Phase 1
N=60
Study of ALXN1820 in Healthy Adult Participants
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04631562 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Number of Participants With Treatment-related Adverse Events (TEAEs) For ALXN1820 SC And ALXN1820 IV — 1; 0; 0; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ALXN1820 SC (Drug); ALXN1820 IV (Drug); Placebo SC (Drug); Placebo IV (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Alexion Pharmaceuticals, Inc.
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Adverse Events (TEAEs) For ALXN1820 SC And ALXN1820 IV |
1; 0; 0; 4; 2; 0 | — |
| SECONDARY Area Under The Concentration-time Curve (AUC) From Time 0 (Dosing) To Time Infinity (AUC0-inf) And AUC During The Dosing Interval (AUCtau) of Serum ALXN1820 For Single Dose Cohorts |
1708.745740; 11871.887397; 22447.444516; 65994.232565; 70222.568018; 157445.098602 | — |
| SECONDARY Area Under The Concentration-time Curve During The Dosing Interval (AUCtau) Of Serum ALXN1820 For Multiple Dose Cohorts |
13047.247486; 14895.697459 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Single Dose Cohorts |
2.346; 12.892; 29.342; 99.256; 162.518; 246.140 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) Of Serum ALXN1820 For Multiple Dose Cohorts |
90.53; 100.97 | — |
| SECONDARY Change From Baseline in Serum Concentrations Of Total Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts |
3.744; 2.093; 1.788; 5.580; 3.014; 15.017 | — |
| SECONDARY Change From Baseline in Serum Concentrations Of Free Properdin For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts |
848.0; 1096.7; 1200.0; 20.8; 1188.4; 5171.8 | — |
| SECONDARY Change From Baseline In Serum Concentrations of Total Properdin For ALXN1820 SC- Multiple Dose Cohorts |
6.018; 9.878; 0.418 | — |
| SECONDARY Change From Baseline In Serum Concentrations of Free Properdin For ALXN1820 SC- Multiple Dose Cohorts |
3775.2; 3762.0; 154.5 | — |
| SECONDARY Change From Baseline In Complement Alternative Pathway (CAP) Activity Using The Wieslab Alternative Pathway (AP) Assay For ALXN1820 SC And ALXN1820 IV-Single Dose Cohorts |
-15.6800; 5.0833; 1.6600; 10.3750; 3.100; 6.6500 | — |
| SECONDARY Change From Baseline In Complement Alternative Pathway Activity Using The Wieslab Alternative Pathway Assay For ALXN1820 SC- Multiple Dose Cohorts |
27.9714; 2.6667; 7.0000 | — |
| SECONDARY Number Of Participants With Positive Antidrug Antibodies (ADAs) To ALXN1820 SC And ALXN1820 IV |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Absolute Bioavailability Of ALXN1820 SC |
89.307 | — |
Summary
This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1820 administered subcutaneously (SC) (ALXN1820 SC) and intravenously (IV) (ALXN1820 IV).
Eligibility Criteria
Inclusion Criteria
- Body weight 50 to 100 kilograms (kg); body mass index 17 to 32 kg/meter squared.
- Cohort 9 only: Japanese participants (defined as those participants whose parents and grandparents are both Japanese and who have spent less than 5 years outside of Japan).
- Satisfactory medical assessment.
- Must follow protocol-specified contraception guidance while on treatment and for up to 6 months after last dose.
- Vaccination requirement:
- Vaccination with tetravalent meningococcal conjugate vaccine at least 56 days and not more than 2 years, 6 months prior to dosing;
- Vaccination with serogroup B meningococcal vaccine at least 56 days prior to dosing, with a booster at least 28 days prior to dosing, with at least 28 days between the first and second injections.
Exclusion Criteria
- Current/recurrent diseases or relevant medical history.
- History of any Neisseria infection.
- Hepatitis B/C, human immunodeficiency virus.
- History of latent or active tuberculosis (TB), or positive TB test.
- Active systemic infection within 14 days of dosing.
- Risk of meningococcal infections due to living/working conditions.
- History of complement deficiency or complement activity below the reference range.
- Participation in a clinical study within 90 days or 5 half lives of the investigational agent (whichever is longer) before initiation of dosing on Day 1.
- Participation in more than 1 clinical study of a monoclonal antibody (mAb), or participation in a clinical study of a mAb within the 6 months or 5 half lives of the mAb (whichever is longer) prior to screening.
- Acquired complement deficiencies (for example, those receiving eculizumab).
Data sourced from ClinicalTrials.gov (NCT04631562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.