A Phase 1 interventional study of ALXN1830 and Placebo in Healthy, sponsored by Alexion Pharmaceuticals, Inc.. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-22.
Sponsored by Alexion Pharmaceuticals, Inc. · Phase 1, Interventional, and Basic science
This study will evaluate the effects of single ascending doses (SAD) and multiple ascending doses (MAD) of ALXN1830 administered subcutaneously (SC) to healthy adult participants.
This Phase 1 study will consist of 3 SAD (Cohorts 1 to 3) and 4 MAD (Cohorts 4 to 7) cohorts. Participants will be randomly assigned in a 6:2 ratio to each of the 7 cohorts to receive either single or multiple doses of ALXN1830 (n = 6 per cohort) or single or multiple doses of placebo (n = 2 per cohort).
Alexion Pharmaceuticals, Inc. is the lead sponsor of 249 studies on the registry; 25 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 70 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive a single SC dose of ALXN1830 or placebo (750 mg).
Drug: ALXN1830 · Drug: Placebo
Participants will receive a single SC dose of ALXN1830 or placebo (1500 mg).
Drug: ALXN1830 · Drug: Placebo
Participants will receive a single SC dose of ALXN1830 or placebo (2250 mg).
Drug: ALXN1830 · Drug: Placebo
Participants will receive multiple SC doses of ALXN1830 or placebo (300 mg twice weekly; 8 doses total).
Drug: ALXN1830 · Drug: Placebo
Participants will receive multiple SC doses of ALXN1830 or placebo (750 mg once weekly; 12 doses total).
Drug: ALXN1830 · Drug: Placebo
Participants will receive multiple SC doses of ALXN1830 or placebo (1500 mg once weekly; 4 doses total).
Drug: ALXN1830 · Drug: Placebo
Participants will receive multiple SC doses of ALXN1830 or placebo (2250 mg once weekly; 4 doses total).
Drug: ALXN1830 · Drug: Placebo
ALXN1830 will be administered as SC infusion(s).
Placebo will be administered as SC infusion(s).
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
A TEAE was defined as any adverse event (AE) that commences after the start of administration of study drug. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An AE was considered serious if, in the view of the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. A summary of all serious AEs and other AEs (nonserious) regardless of causality is located in 'Adverse events' Section.
Time frame: Baseline up to Day 64
Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To The Last Quantifiable Concentration (AUC0-t) of ALXN1830
Time frame: Predose, end of infusion, and 0.5, 2, 4, 8, and 12 hours postdose on Day 1; and Days 2 to 8
Percent Change From Baseline in Immunoglobulin G (IgG) Levels at Day 10
Time frame: Baseline, Day 10
Number of Participants With Positive Anti-Drug Antibodies (ADA)
Time frame: Baseline up to Day 64
Number of Participants With Positive Neutralizing Antibodies (NAbs)
All samples that are confirmed positive for ADA were evaluated for the presence of neutralizing antibodies.
Time frame: Baseline up to Day 64
| Milestone | ALXN1830 750 mg | ALXN1830 1250 mg | Placebo |
|---|---|---|---|
| Started | 6 | 3 | 3 |
| Received at least 1 dose of study drug | 6 | 3 | 3 |
| Completed | 6 | 3 | 2 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 |
| hour*nanogram/milliliter | ALXN1830 750 mg | ALXN1830 1250 mg |
|---|---|---|
| Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To The Last Quantifiable Concentration (AUC0-t) of ALXN1830 | 31.8 | 44.2 ± 33.7 |
| percent change | ALXN1830 750 mg | ALXN1830 1250 mg | Placebo |
|---|---|---|---|
| Percent Change From Baseline in Immunoglobulin G (IgG) Levels at Day 10 | -36.137 ± 3.7163 | -39.044 ± 2.0933 | -2.369 ± 6.6831 |
| Participants | ALXN1830 750 mg | ALXN1830 1250 mg | Placebo |
|---|---|---|---|
| Number of Participants With Positive Anti-Drug Antibodies (ADA) | 4 | 2 | 0 |
All samples that are confirmed positive for ADA were evaluated for the presence of neutralizing antibodies.
| Participants | ALXN1830 750 mg | ALXN1830 1250 mg | Placebo |
|---|---|---|---|
| Number of Participants With Positive Neutralizing Antibodies (NAbs) | 2 | 2 | — |
A TEAE was defined as any adverse event (AE) that commences after the start of administration of study drug. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An AE was considered serious if, in the view of the investigator or sponsor, it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. A summary of all serious AEs and other AEs (nonserious) regardless of causality is located in 'Adverse events' Section.
| Participants | ALXN1830 750 mg | ALXN1830 1250 mg | Placebo |
|---|---|---|---|
| AEs | 5 | 3 | 3 |
| SAEs | 0 | 0 | 0 |
Collected over Baseline up to Day 64. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ALXN1830 750 mg | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| ALXN1830 1250 mg | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Placebo | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Event | ALXN1830 750 mg | ALXN1830 1250 mg | Placebo |
|---|---|---|---|
| Viral upper respiratory tract infectionInfections and infestations | 5/6 | 3/3 | 2/3 |
| HeadacheNervous system disorders | 0/6 | 2/3 | 1/3 |
| PruritusSkin and subcutaneous tissue disorders | 0/6 | 2/3 | 0/3 |
| Injection site discomfortGeneral disorders | 0/6 | 2/3 | 0/3 |
| DiarrhoeaGastrointestinal disorders | 0/6 | 1/3 | 0/3 |
| Food poisoningGastrointestinal disorders | 0/6 | 1/3 | 0/3 |
| DizzinessNervous system disorders | 0/6 | 1/3 | 0/3 |
| Dry skinSkin and subcutaneous tissue disorders | 0/6 | 1/3 | 0/3 |
| Rash pruriticSkin and subcutaneous tissue disorders | 0/6 | 1/3 | 0/3 |
| Chest painGeneral disorders | 0/6 | 0/3 | 1/3 |
The safety population consisted of all participants who received at least 1 dose of study drug.
| Age, Continuous(years) | ALXN1830 750 mg | ALXN1830 1250 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 22.8 ± 2.93 | 23.0 ± 3.46 | 28.3 ± 5.86 | 24.3 ± 4.29 |
| Sex: Female, Male(Participants) | ALXN1830 750 mg | ALXN1830 1250 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 3 | 3 | 1 | 7 |
| Male | 3 | 0 | 2 | 5 |
| Race/Ethnicity, Customized(Participants) | ALXN1830 750 mg | ALXN1830 1250 mg | Placebo | Total |
|---|---|---|---|---|
| Race — White | 3 | 3 | 2 | 8 |
| Race — Chinese | 0 | 0 | 1 | 1 |
| Race — Other Asian | 1 | 0 | 0 | 1 |
| Race — Other | 2 | 0 | 0 | 2 |
| Race/Ethnicity, Customized(Participants) | ALXN1830 750 mg | ALXN1830 1250 mg | Placebo | Total |
|---|---|---|---|---|
| Not of Hispanic, Latino/a, or Spanish Origin | 6 | 3 | 2 | 11 |
| Another Hispanic, Latino/a, or Spanish Origin | 0 | 0 | 1 | 1 |
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Alexion Pharmaceuticals, Inc.