A Study of ALXN1830 in Healthy Adult Participants
Study Details
Study Description
Brief Summary
This trial will study the effects of single and multiple doses of ALXN1830 in healthy adult participants.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1: ALXN1830 Single Dose 1/Placebo Participants will receive a single SC dose of ALXN1830 or placebo. |
Drug: ALXN1830
ALXN1830 will be administered as SC infusion(s).
Drug: Placebo
Placebo will be administered as SC infusion(s).
Other Names:
|
| Experimental: Cohort 2: ALXN1830 Single Dose 2/Placebo Participants will receive a single SC dose of ALXN1830 or placebo. |
Drug: ALXN1830
ALXN1830 will be administered as SC infusion(s).
Drug: Placebo
Placebo will be administered as SC infusion(s).
Other Names:
|
| Experimental: Cohort 3: ALXN1830 Multiple Dose 1/Placebo Participants will receive multiple SC doses of ALXN1830 or placebo. |
Drug: ALXN1830
ALXN1830 will be administered as SC infusion(s).
Drug: Placebo
Placebo will be administered as SC infusion(s).
Other Names:
|
| Experimental: Cohort 4: ALXN1830 Multiple Dose 2/Placebo Participants will receive multiple SC doses of ALXN1830 or placebo. |
Drug: ALXN1830
ALXN1830 will be administered as SC infusion(s).
Drug: Placebo
Placebo will be administered as SC infusion(s).
Other Names:
|
| Experimental: Cohort 5: ALXN1830 Multiple Dose 3/Placebo Participants will receive multiple SC doses of ALXN1830 or placebo. |
Drug: ALXN1830
ALXN1830 will be administered as SC infusion(s).
Drug: Placebo
Placebo will be administered as SC infusion(s).
Other Names:
|
| Experimental: Cohort 6: ALXN1830 /Placebo in Japanese Population Japanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo. |
Drug: ALXN1830
ALXN1830 will be administered as SC infusion(s).
Drug: Placebo
Placebo will be administered as SC infusion(s).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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.
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Participants who have prior exposure to ALXN1830.
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Current enrollment or past participation within the last 90 days before signing of consent in this or any other interventional clinical study.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Trial Site | Auckland | New Zealand |
Sponsors and Collaborators
- Alexion Pharmaceuticals
- Syneos Health
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALXN1830-HV-108
- 2020-001081-11