Status:
TERMINATED
A Study of ALXN1830 in Healthy Adult Participants
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Collaborating Sponsors:
Syneos Health
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This trial will study the effects of single and multiple doses of ALXN1830 in healthy adult participants.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04730804
Start Date
March 17 2021
End Date
January 4 2022
Last Update
September 19 2024
Active Locations (2)
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1
Clinical Trial Site
Auckland, New Zealand
2
Research Site
Grafton, New Zealand, 1010