A Study of ALXN1830 in Healthy Adult Participants

Alexion Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: ALXN1830; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04730804

ALXN1830-HV-108

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 6 patient groups

Cohort 1: ALXN1830 Single Dose 1/Placebo

Experimental group

Description:

Participants will receive a single SC dose of ALXN1830 or placebo.

Treatment:

Drug: Placebo

Drug: ALXN1830

Cohort 2: ALXN1830 Single Dose 2/Placebo

Experimental group

Description:

Participants will receive a single SC dose of ALXN1830 or placebo.

Treatment:

Drug: Placebo

Drug: ALXN1830

Cohort 3: ALXN1830 Multiple Dose 1/Placebo

Experimental group

Description:

Participants will receive multiple SC doses of ALXN1830 or placebo.

Treatment:

Drug: Placebo

Drug: ALXN1830

Cohort 4: ALXN1830 Multiple Dose 2/Placebo

Experimental group

Description:

Participants will receive multiple SC doses of ALXN1830 or placebo.

Treatment:

Drug: Placebo

Drug: ALXN1830

Cohort 5: ALXN1830 Multiple Dose 3/Placebo

Experimental group

Description:

Participants will receive multiple SC doses of ALXN1830 or placebo.

Treatment:

Drug: Placebo

Drug: ALXN1830

Cohort 6: ALXN1830 /Placebo in Japanese Population

Experimental group

Description:

Japanese participants will receive multiple SC doses of ALXN1830 (HTD) or placebo.

Treatment:

Drug: Placebo

Drug: ALXN1830