Study of ALXN1820 in Healthy Adult Participants

NCT ID: NCT04631562

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2022-09-01

Brief Summary

This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1820 administered subcutaneously (SC) (ALXN1820 SC) and intravenously (IV) (ALXN1820 IV).

Detailed Description

This study will include up to 10 different dosing cohorts, with each cohort consisting of 2 groups (ALXN1820 group, placebo group). Participants will be randomly assigned in a 3:1 ratio to each of these 2 groups, respectively, within all 10 cohorts, to receive either a single or multiple doses of ALXN1820 SC, a single dose of ALXN1820 IV, or a single or multiple doses of placebo.

The study will be conducted in healthy adult participants and will also include a multiple SC dose cohort in healthy participants of Japanese descent.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

ALXN1820

Participants will receive ALXN1820 SC or ALXN1820 IV according to their assigned cohort. ALXN1820 SC will be evaluated in single and multiple ascending doses while ALXN1820 IV will be evaluated in a single dose cohort only.

Group Type: EXPERIMENTAL

ALXN1820 SC

Intervention Type: DRUG

ALXN1820 SC will be administered as a manual SC push or SC infusion via a syringe pump. Doses will range from 12.5 milligrams (mg) to a maximum of 2250 mg. Multiple dosing duration will range from 3 to 5 weeks.

ALXN1820 IV

Intervention Type: DRUG

ALXN1820 IV (450 mg) will be administered as an IV infusion.

Placebo

Participants will receive Placebo SC or Placebo IV according to their assigned cohort.

Group Type: PLACEBO_COMPARATOR

Placebo SC

Intervention Type: DRUG

Placebo SC will be administered as a manual SC push or SC infusion via a syringe pump.

Placebo IV

Intervention Type: DRUG

Placebo IV will be administered as an IV infusion.

Interventions

ALXN1820 SC

ALXN1820 SC will be administered as a manual SC push or SC infusion via a syringe pump. Doses will range from 12.5 milligrams (mg) to a maximum of 2250 mg. Multiple dosing duration will range from 3 to 5 weeks.

Intervention Type: DRUG

ALXN1820 IV

ALXN1820 IV (450 mg) will be administered as an IV infusion.

Intervention Type: DRUG

Placebo SC

Placebo SC will be administered as a manual SC push or SC infusion via a syringe pump.

Intervention Type: DRUG

Placebo IV

Placebo IV will be administered as an IV infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body weight 50 to 100 kilograms (kg); body mass index 17 to 32 kg/meter squared.
• Cohort 9 only: Japanese participants (defined as those participants whose parents and grandparents are both Japanese and who have spent less than 5 years outside of Japan).
• Satisfactory medical assessment.
• Must follow protocol-specified contraception guidance while on treatment and for up to 6 months after last dose.
• Vaccination requirement:

• Vaccination with tetravalent meningococcal conjugate vaccine at least 56 days and not more than 2 years, 6 months prior to dosing;
• Vaccination with serogroup B meningococcal vaccine at least 56 days prior to dosing, with a booster at least 28 days prior to dosing, with at least 28 days between the first and second injections.

Exclusion Criteria

• Current/recurrent diseases or relevant medical history.
• History of any Neisseria infection.
• Hepatitis B/C, human immunodeficiency virus.
• History of latent or active tuberculosis (TB), or positive TB test.
• Active systemic infection within 14 days of dosing.
• Risk of meningococcal infections due to living/working conditions.
• History of complement deficiency or complement activity below the reference range.
• Participation in a clinical study within 90 days or 5 half lives of the investigational agent (whichever is longer) before initiation of dosing on Day 1.
• Participation in more than 1 clinical study of a monoclonal antibody (mAb), or participation in a clinical study of a mAb within the 6 months or 5 half lives of the mAb (whichever is longer) prior to screening.
• Acquired complement deficiencies (for example, those receiving eculizumab).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Herston, , Australia

Research Site

London, , United Kingdom

Research Site

London, , United Kingdom

Countries

Australia; United Kingdom

References

Sandhu A, Shen T, Herrero PM, Yuan CX, Qureshi S, Jiang X, Sheng Y, Gasteyger C, Dai Y. Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of ALXN1820 (Tarperprumig) in Healthy Adults: Results of a Phase I Study. Clin Transl Sci. 2025 Apr;18(4):e70190. doi: 10.1111/cts.70190.

Reference Type: DERIVED

PMID: 40134111 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2021-002472-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ALXN1820-HV-101

Identifier Type: -

Identifier Source: org_study_id