A Study of ALXN1830 in Healthy Adult Participants

Study Overview
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Brief Summary
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This trial will study the effects of single and multiple doses of ALXN1830 in healthy adult participants.

Detailed Description
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This is a Phase 1 study in healthy adult participants. The study will consist of 2 single ascending dose (Cohorts 1 and 2) and 4 multiple ascending dose cohorts (Cohorts 3 to 6). Participants will be randomly assigned to each of the 6 cohorts to receive either single or multiple doses of ALXN1830 subcutaneous (SC) or single or multiple doses of placebo SC. Cohort 6 will enroll only healthy participants of Japanese descent who will be dosed according to the highest tolerated dose (HTD) established in the non-Japanese cohorts.

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: ALXN1830
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Satisfactory medical assessment. Participants must have had vaccination against pneumococcus (Pneumovax 23 [PPSV23]) at least 28 days, and maximally 4 years prior to Day 1. Participants must have had seasonal influenza vaccination for the current season at least 28 days prior to Day 1. Body weight within 60 to 90 kilograms (kg), inclusive, and body mass index within 18 to 30 kg/meter squared, inclusive. Must be willing to follow protocol-specified contraception guidance during the study and for 3 months after last dose of study drug. Exclusion Criteria: Current/recurrent diseases or relevant medical history. Known exposure to investigational or marketed therapeutic proteins, such as monoclonal antibodies, fusion proteins, bispecific molecules, or antibody drug conjugates, within 60 days or 5 half-lives (whichever is longer) prior to dosing. Participants who have prior exposure to ALXN1830. Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study. Participants with hepatitis B or C, or human immunodeficiency virus. Participants who are either immunocompromised or have one of the following underlying medical conditions: anatomic or functional asplenia (including sickle cell disease); primary antibody deficiencies.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: ALXN1830 Single Dose 1/Placebo<br>Participants will receive a single SC dose of ALXN1830 or placebo. | Drug: ALXN1830<br>* ALXN1830 will be administered as SC infusion(s).<br>Drug: Placebo<br>* Placebo will be administered as SC infusion(s).<br>* Other names: Normal Saline;|
| Experimental: Cohort 2: ALXN1830 Single Dose 2/Placebo<br>Participants will receive a single SC dose of ALXN1830 or placebo. | Drug: ALXN1830<br>* ALXN1830 will be administered as SC infusion(s).<br>Drug: Placebo<br>* Placebo will be administered as SC infusion(s).<br>* Other names: Normal Saline;|
| Experimental: Cohort 3: ALXN1830 Multiple Dose 1/Placebo<br>Participants will receive multiple SC doses of ALXN1830 or placebo. | Drug: ALXN1830<br>* ALXN1830 will be administered as SC infusion(s).<br>Drug: Placebo<br>* Placebo will be administered as SC infusion(s).<br>* Other names: Normal Saline;|
| Experimental: Cohort 4: ALXN1830 Multiple Dose 2/Placebo<br>Participants will receive multiple SC doses of ALXN1830 or placebo. | Drug: ALXN1830<br>* ALXN1830 will be administered as SC infusion(s).<br>Drug: Placebo<br>* Placebo will be administered as SC infusion(s).<br>* Other names: Normal Saline;|
| Experimental: Cohort 5: ALXN1830 Multiple Dose 3/Placebo<br>Participants will receive multiple SC doses of ALXN1830 or placebo. | Drug: ALXN1830<br>* ALXN1830 will be administered as SC infusion(s).<br>Drug: Placebo<br>* Placebo will be administered as SC infusion(s).<br>* Other names: Normal Saline;|
| Experimental: Cohort 6: ALXN1830 /Placebo in Japanese Population<br>Japanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo. | Drug: ALXN1830<br>* ALXN1830 will be administered as SC infusion(s).<br>Drug: Placebo<br>* Placebo will be administered as SC infusion(s).<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number Of Participants With Treatment-emergent Adverse Events |  | Day 1 (postdose) through follow-up (up to 63 [+/- 1] days after last study drug administration) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under The Concentration-time Curve From Time 0 (Dosing) To Time Infinity (AUC0-inf) Of Serum ALXN1830 For Single And Multiple Doses |  | Up to 141 days postdose | 
| Change From Baseline In Serum Immunoglobulin G (IgG) For Single And Multiple Doses Of ALXN1830 |  | Up to 141 days postdose | 
| Comparison Of Incidences Of Treatment-emergent Adverse Events Between Healthy Non-Japanese Participants And Participants Of Japanese Descent For Multiple HTDs Of ALXN1830 |  | Day 1 (postdose) through follow-up (up to 63 [+/- 1] days after last study drug administration) | 
| Comparison Of AUC0-inf Between Healthy Non-Japanese Participants And Participants Of Japanese Descent For Multiple HTDs Of ALXN1830 |  | Up to 141 days postdose | 
| Comparison Of IgG Levels Between Healthy Non-Japanese Participants And Participants Of Japanese Descent For Multiple HTDs Of ALXN1830 |  | Up to 141 days postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALXN1830, Autoimmune Disease, Pharmacokinetics, Pharmacodynamics