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Active, Not Recruiting

NCT Number: NCT05501717

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Harrow, HA1 3UJ, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALXN2030

Drug

ALXN2030 will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.

Placebo

Drug

Placebo will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    Time frame: Day 1 through through study completion, an average of 1 year

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Days 1 (predose; end of infusion (EOI); and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127

  2. Time to Maximum Observed Plasma Concentration (Tmax)

    Time frame: Days 1 (predose; EOI; and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127

  3. Area Under the Plasma Concentration Versus Time Curve From Time 0 (Dosing) to the Last Quantifiable Concentration (AUCt)

    Time frame: Days 1 (predose; EOI; and 0.25, 0.5, 1, 2, 4, 6, 8, and 12 hours post-EOI), 2, 3, 5, 8, 15, 22, 29, 36, 43, 50, 57, 71, 85, 99, and 127

  4. Change from Baseline in Plasma Concentration of Complement Component 3 (C3) Protein

    Time frame: Baseline (Day 1) and study completion, an average of 1 year

  5. Change from Baseline in Serum Complement Functional Activity

    Time frame: Baseline (Day 1) and Day 127

  6. Number of Participants With Treatment-Emergent Antidrug Antibodies (ADAs)

    Time frame: Days 1 through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Subcutaneous ALXN2030 in Healthy Participants

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 15, 2022
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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