Clinical trial NCT04730804: A Study of ALXN1830 in Healthy Adult Participants
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: ALXN1830
Autoimmune Disease
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2021-01-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility 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.
* 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 (postdose) through follow-up (up to approximately 141 days)
Secondary outcomes:
measure: Single-Dose Cohorts: Area Under the Serum Concentration-time Curve From Time 0 (Dosing) To Time Infinity (AUC0-inf) of ALXN1830
timeFrame: Day 1 (predose) up to Day 64 (postdose)
measure: Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 1
timeFrame: Day 1 (predose up to 12 hours postdose)
measure: Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 22
timeFrame: Day 22 (predose up to 12 hours postdose)
measure: Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 78
timeFrame: Day 78 (predose up to 12 hours postdose)
measure: Change From Baseline in Serum Immunoglobulin G (IgG) at Early Termination Visit (up to Day 141)
timeFrame: Baseline, early termination visit (up to Day 141)
measure: Percent FcRN Receptor Occupancy at Day 120
timeFrame: Day 120
measure: Number of Participants With Antidrug Antibodies (ADA) and Neutralizing Antibodies (NAb) to ALXN1830
timeFrame: Day 1 (postdose) through follow-up (up to approximately 141 days)
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Clinical Trial Site
city: Grafton
country: New Zealand
facility: Research Site
Study officials:
References: