Safety, PK/PD, and Immunogenicity Study of SC ALXN2030 in Healthy Participants

Alexion Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy

Treatments: Drug: ALXN2030; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05501717

ALXN2030-HV-101

Details and patient eligibility

About

The primary purpose of this study is to assess the safety and tolerability of single ascending doses of ALXN2030 in healthy participants.

Full description

Approximately 48 healthy adult participants (36 participants will be on ALXN2030 and 12 participants will be on placebo) are expected to be enrolled.

Enrollment: 48 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy participants
• QTcF ≤ 450 msec at Screening and on admission (ie, on Day -1).
• Participants of Japanese descent are defined as: First generation (born to 2 Japanese parents and 4 Japanese grandparents).
• Participants of Japanese descent must be between 20 and 60 years of age.
• BMI within the range 18-32kg/m2 (inclusive) at Screening.

Exclusion criteria

• Current or recurrent disease
• Current or relevant history of physical or psychiatric illness.
• Any other significant disease or disorder that, in the opinion of the Investigator, may put the participant at risk.
• Female participants who are pregnant or breastfeeding.
• Major surgery or hospitalization within 90 days prior to dosing on Day1.
• History of allergy or hypersensitivity to an oligonucleotide or GalNAc moiety or any excipients of ALXN2030.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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48 participants in 6 patient groups, including a placebo group

ALXN2030 Dose A

Experimental group

Description:

ALXN2030 will be administered as a single dose.

Treatment:

Drug: ALXN2030

ALXN2030 Dose B

Experimental group

Description:

ALXN2030 will be administered as a single dose.

Treatment:

Drug: ALXN2030

ALXN2030 Dose C

Experimental group

Description:

ALXN2030 will be administered as a single dose.

Treatment:

Drug: ALXN2030

ALXN2030 Dose D

Experimental group

Description:

ALXN2030 will be administered as a single dose.

Treatment:

Drug: ALXN2030

ALXN2030 Dose E

Experimental group

Description:

ALXN2030 will be administered as a single dose.

Treatment:

Drug: ALXN2030

Placebo

Placebo Comparator group

Description:

Placebo will be administered as a single dose.

Treatment:

Drug: Placebo