Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects

Alexion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo IV; Drug: Placebo SC; Drug: ALXN1720 IV; Drug: rHuPH20; Drug: ALXN1720 SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04920370

ALXN1720-HV-101

2018-004500-19 (EudraCT Number)

Details and patient eligibility

About

This study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1720 administered subcutaneously (SC) or intravenously (IV).

Full description

Participants will be randomized in a 3:1 ratio to receive the active treatment or placebo.

The study will be conducted in healthy adult participants, including participants of Japanese descent.

Enrollment: 97 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body weight within 50 to 90 kilograms (kg), inclusive, and body mass index within the range of 18 to 29.9 kg/meter squared, inclusive.
• Willing to follow protocol-specified contraception guidance while on treatment and for 6 months after the last dose of study treatment.
• Vaccination with tetravalent meningococcal conjugate vaccine and serogroup B meningococcal vaccine.
• No clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory evaluation.
• For the cohorts with Japanese participants, parents and grandparents must both be Japanese, and participants must have resided for less than 5 years outside of Japan.

Exclusion criteria

• Current or recurrent disease that could affect clinical assessments or clinical laboratory evaluations.
• History of complement deficiency or complement activity below the reference range.
• Female participants who are breastfeeding.
• Immunization with a live-attenuated vaccine 28 days prior to dosing on Day 1 or planned vaccination during the course of the study. Immunization with inactivated or recombinant influenza vaccine, or nucleoside-modified messenger ribonucleic acid or recombinant COVID-19 vaccine is permitted.
• Current tobacco smoking, history of illicit drug abuse, or history of significant alcohol abuse.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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97 participants in 5 patient groups, including a placebo group

ALXN1720 Single Dose SC

Experimental group

Description:

Participants will receive a single dose of ALXN1720 SC.

Treatment:

Drug: ALXN1720 SC

ALXN1720 Multiple Dose SC

Experimental group

Description:

Participants will receive multiple doses of ALXN1720 SC.

Treatment:

Drug: ALXN1720 SC

ALXN1720 Single Dose SC + rHuPH20

Experimental group

Description:

Participants will receive a single dose of ALXN1720 SC in combination with rHuPH20.

Treatment:

Drug: ALXN1720 SC

Drug: rHuPH20

ALXN1720 Single Dose IV

Experimental group

Description:

Participants will receive a single dose of ALXN1720 IV.

Treatment:

Drug: ALXN1720 IV

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo IV

Drug: Placebo SC