ALXN2030: 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: Placebo will be administered subcutaneously as a single dose either as a manual SC injection or as an SC infusion via a syringe pump.
Study summary
The primary purpose of this study is to assess the safety and tolerability of single ascending doses of ALXN2030 in healthy participants.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) — Day 1 through through study completion, an average of 1 year
Trial sites (1)
Facility
City
Region
Status
Research Site
Harrow
United Kingdom
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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