Study Stopped
Sponsor decision to terminate program
A Study of ALXN1830 in Healthy Adult Participants
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants
1 other identifier
interventional
34
1 country
2
Brief Summary
This trial will study the effects of single and multiple doses of ALXN1830 in healthy adult participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Mar 2021
Longer than P75 for phase_1 healthy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2021
CompletedFirst Posted
Study publicly available on registry
January 29, 2021
CompletedStudy Start
First participant enrolled
March 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2022
CompletedResults Posted
Study results publicly available
September 19, 2024
CompletedSeptember 19, 2024
September 1, 2024
9 months
January 26, 2021
August 9, 2023
September 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a participant administered the study drug and which did not necessarily have a causal relationship with this treatment. A TEAE was defined as an AE with a start date or time on or after the first dose of the study intervention. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Day 1 (postdose) through follow-up (up to approximately 141 days)
Secondary Outcomes (7)
Single-Dose Cohorts: Area Under the Serum Concentration-time Curve From Time 0 (Dosing) To Time Infinity (AUC0-inf) of ALXN1830
Day 1 (predose) up to Day 64 (postdose)
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 1
Day 1 (predose up to 12 hours postdose)
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 22
Day 22 (predose up to 12 hours postdose)
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 78
Day 78 (predose up to 12 hours postdose)
Change From Baseline in Serum Immunoglobulin G (IgG) at Early Termination Visit (up to Day 141)
Baseline, early termination visit (up to Day 141)
- +2 more secondary outcomes
Study Arms (6)
Cohort 1: ALXN1830 Single Dose 1/Placebo
EXPERIMENTALParticipants will receive a single SC dose of ALXN1830 or placebo.
Cohort 2: ALXN1830 Single Dose 2/Placebo
EXPERIMENTALParticipants will receive a single SC dose of ALXN1830 or placebo.
Cohort 3: ALXN1830 Multiple Dose 1/Placebo
EXPERIMENTALParticipants will receive multiple SC doses of ALXN1830 or placebo.
Cohort 4: ALXN1830 Multiple Dose 2/Placebo
EXPERIMENTALParticipants will receive multiple SC doses of ALXN1830 or placebo.
Cohort 5: ALXN1830 Multiple Dose 3/Placebo
EXPERIMENTALParticipants will receive multiple SC doses of ALXN1830 or placebo.
Cohort 6: ALXN1830 /Placebo in Japanese Population
EXPERIMENTALJapanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo.
Interventions
ALXN1830 will be administered as SC infusion(s).
Placebo will be administered as SC infusion(s).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alexion Pharmaceuticals, Inc.lead
- Syneos Healthcollaborator
Study Sites (2)
Clinical Trial Site
Auckland, New Zealand
Research Site
Grafton, 1010, New Zealand
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alexion Pharmaceuticals, Inc.
- Organization
- Alexion Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2021
First Posted
January 29, 2021
Study Start
March 17, 2021
Primary Completion
December 14, 2021
Study Completion
January 4, 2022
Last Updated
September 19, 2024
Results First Posted
September 19, 2024
Record last verified: 2024-09