Study of ALXN1820 in Healthy Adult Participants

Alexion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ALXN1820 IV; Drug: Placebo IV; Drug: ALXN1820 SC; Drug: Placebo SC

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04631562

2021-002472-39 (EudraCT Number)

ALXN1820-HV-101

Details and patient eligibility

About

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).

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

ALXN1820

Experimental group

Description:

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.

Treatment:

Drug: ALXN1820 SC

Drug: ALXN1820 IV

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo SC

Drug: Placebo IV