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

Launched by ALEXION PHARMACEUTICALS, INC. · Aug 12, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called ALXN2030 to find out how safe it is and how it affects healthy people. The trial will give participants different doses of ALXN2030 to see how their bodies react to it. The goal is to understand if the medicine is well-tolerated and to gather information about its effects.

To participate, you need to be a healthy adult between the ages of 20 and 60, specifically of Japanese descent, and meet certain health criteria, like having a normal heart rhythm. Participants should not have any ongoing health issues or any serious medical conditions that could put them at risk. If you join the study, you will receive the medication and be closely monitored by healthcare professionals to ensure your safety throughout the trial. This is an exciting opportunity to contribute to medical research while helping to test a new treatment!

Gender

ALL

Eligibility criteria

• 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.