A Study of ALXN1830 in Healthy Adult Participants
- Registration Number
- NCT04730804
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 48
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: ALXN1830 Single Dose 1/Placebo Placebo Participants will receive a single SC dose of ALXN1830 or placebo. Cohort 4: ALXN1830 Multiple Dose 2/Placebo ALXN1830 Participants will receive multiple SC doses of ALXN1830 or placebo. Cohort 5: ALXN1830 Multiple Dose 3/Placebo ALXN1830 Participants will receive multiple SC doses of ALXN1830 or placebo. Cohort 3: ALXN1830 Multiple Dose 1/Placebo ALXN1830 Participants will receive multiple SC doses of ALXN1830 or placebo. Cohort 5: ALXN1830 Multiple Dose 3/Placebo Placebo Participants will receive multiple SC doses of ALXN1830 or placebo. Cohort 1: ALXN1830 Single Dose 1/Placebo ALXN1830 Participants will receive a single SC dose of ALXN1830 or placebo. Cohort 2: ALXN1830 Single Dose 2/Placebo Placebo Participants will receive a single SC dose of ALXN1830 or placebo. Cohort 3: ALXN1830 Multiple Dose 1/Placebo Placebo Participants will receive multiple SC doses of ALXN1830 or placebo. Cohort 4: ALXN1830 Multiple Dose 2/Placebo Placebo Participants will receive multiple SC doses of ALXN1830 or placebo. Cohort 6: ALXN1830 /Placebo in Japanese Population Placebo Japanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo. Cohort 2: ALXN1830 Single Dose 2/Placebo ALXN1830 Participants will receive a single SC dose of ALXN1830 or placebo. Cohort 6: ALXN1830 /Placebo in Japanese Population ALXN1830 Japanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Day 1 (postdose) through follow-up (up to approximately 141 days) 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.
- Secondary Outcome Measures
Name Time Method 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) Serum total drug concentrations were measured using a validated liquid chromatography/mass spectrometry (LC/MS) assay.
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 1 Day 1 (predose up to 12 hours postdose) Serum total drug concentrations were measured using a validated LC/MS assay.
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 22 Day 22 (predose up to 12 hours postdose) Serum total drug concentrations were measured using a validated LC/MS assay.
Multiple-Dose Cohorts: AUC0-inf of ALXN1830 at Day 78 Day 78 (predose up to 12 hours postdose) Serum total drug concentrations were measured using a validated LC/MS assay.
Change From Baseline in Serum Immunoglobulin G (IgG) at Early Termination Visit (up to Day 141) Baseline, early termination visit (up to Day 141) Serum concentration of IgG was measured using validated nephelometric assays.
Percent FcRN Receptor Occupancy at Day 120 Day 120 Number of Participants With Antidrug Antibodies (ADA) and Neutralizing Antibodies (NAb) to ALXN1830 Day 1 (postdose) through follow-up (up to approximately 141 days)
Trial Locations
- Locations (2)
Research Site
🇳🇿Grafton, New Zealand
Clinical Trial Site
🇳🇿Auckland, New Zealand