A Study of ALXN1830 in Healthy Adult Participants

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04730804
• Other study ID #: ALXN1830-HV-108
• Secondary ID: 2020-001081-11
• Status: Terminated
• Phase: Phase 1
• Start date: March 17, 2021
• Est. completion date: January 4, 2022

Study information

• Verified date: January 2023
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial will study the effects of single and multiple doses of ALXN1830 in healthy adult participants.

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 information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: January 4, 2022
• Est. primary completion date: December 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ALXN1830
ALXN1830 will be administered as SC infusion(s).
• Placebo
Placebo will be administered as SC infusion(s).

Locations

Country	Name	City	State
New Zealand	Clinical Trial Site	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals	Syneos Health

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change From Baseline In Serum Immunoglobulin G (IgG) For Single And Multiple Doses Of ALXN1830		Up to 141 days postdose
Secondary	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)
Secondary	Comparison Of AUC0-inf Between Healthy Non-Japanese Participants And Participants Of Japanese Descent For Multiple HTDs Of ALXN1830		Up to 141 days postdose
Secondary	Comparison Of IgG Levels Between Healthy Non-Japanese Participants And Participants Of Japanese Descent For Multiple HTDs Of ALXN1830		Up to 141 days postdose