A Study of ALXN1830 in Healthy Adult Participants

• ClinicalTrials.gov Identifier: NCT04730804
• Recruitment Status: Terminated
• First Posted: January 29, 2021
• Last Update Posted: February 23, 2022
• Sponsor: Alexion Pharmaceuticals
• Collaborator: Syneos Health
• Information provided by (Responsible Party): Alexion Pharmaceuticals

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: ALXN1830; Drug: Placebo	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants
• Actual Study Start Date: March 17, 2021
• Actual Primary Completion Date: December 14, 2021
• Actual Study Completion Date: January 4, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort 1: ALXN1830 Single Dose 1/Placebo; Participants will receive a single SC dose of ALXN1830 or placebo.	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).; Other Name: Normal Saline
Experimental: Cohort 2: ALXN1830 Single Dose 2/Placebo; Participants will receive a single SC dose of ALXN1830 or placebo.	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).; Other Name: Normal Saline
Experimental: Cohort 3: ALXN1830 Multiple Dose 1/Placebo; Participants will receive multiple SC doses of ALXN1830 or placebo.	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).; Other Name: Normal Saline
Experimental: Cohort 4: ALXN1830 Multiple Dose 2/Placebo; Participants will receive multiple SC doses of ALXN1830 or placebo.	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).; Other Name: Normal Saline
Experimental: Cohort 5: ALXN1830 Multiple Dose 3/Placebo; Participants will receive multiple SC doses of ALXN1830 or placebo.	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).; Other Name: Normal Saline
Experimental: Cohort 6: ALXN1830 /Placebo in Japanese Population; Japanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo.	Drug: ALXN1830; ALXN1830 will be administered as SC infusion(s).; Drug: Placebo; Placebo will be administered as SC infusion(s).; Other Name: Normal Saline

Outcome Measures

Primary Outcome Measures :

1. Number Of Participants With Treatment-emergent Adverse Events [ Time Frame: Day 1 (postdose) through follow-up (up to 63 [+/- 1] days after last study drug administration) ]

Secondary Outcome Measures :

1. Area Under The Concentration-time Curve From Time 0 (Dosing) To Time Infinity (AUC0-inf) Of Serum ALXN1830 For Single And Multiple Doses [ Time Frame: Up to 141 days postdose ]
2. Change From Baseline In Serum Immunoglobulin G (IgG) For Single And Multiple Doses Of ALXN1830 [ Time Frame: Up to 141 days postdose ]
3. Comparison Of Incidences Of Treatment-emergent Adverse Events Between Healthy Non-Japanese Participants And Participants Of Japanese Descent For Multiple HTDs Of ALXN1830 [ Time Frame: Day 1 (postdose) through follow-up (up to 63 [+/- 1] days after last study drug administration) ]
4. Comparison Of AUC0-inf Between Healthy Non-Japanese Participants And Participants Of Japanese Descent For Multiple HTDs Of ALXN1830 [ Time Frame: Up to 141 days postdose ]
5. Comparison Of IgG Levels Between Healthy Non-Japanese Participants And Participants Of Japanese Descent For Multiple HTDs Of ALXN1830 [ Time Frame: Up to 141 days postdose ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

New Zealand

Clinical Trial Site

Auckland, New Zealand

Sponsors and Collaborators

Alexion Pharmaceuticals

Syneos Health

More Information

• Responsible Party: Alexion Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04730804
• Other Study ID Numbers: ALXN1830-HV-108; 2020-001081-11 ( EudraCT Number )
• First Posted: January 29, 2021
• Last Update Posted: February 23, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Alexion Pharmaceuticals:

ALXN1830; Autoimmune Disease; Pharmacokinetics; Pharmacodynamics