Safety, PK/PD, and Immunogenicity Study of SC ALXN2030 in Healthy Participants
Study Identifier:
ALXN2030-HV-101
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Recruitment Complete
Study Details
Medical Condition
- Other
Study Drug
- Drug: ALXN2030
- Drug: Placebo
Date
Aug 2022 - Oct 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 60 Years
Requirements Information
Inclusion and Exclusion 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.
Sex
Female & Male
Age
18 - 60 Years
Study Details
Medical Condition
- Other
Study Drug
- Drug: ALXN2030
- Drug: Placebo
Date
Aug 2022 - Oct 2026
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 60 Years years
Requirements Information
Inclusion and Exclusion 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.
Protocol Summary
The primary purpose of this study is to assess the safety and tolerability of single ascending doses of ALXN2030 in healthy participants.
Trial Locations
Location
Status
Location
Research Site
Harrow, United Kingdom, HA1 3UJ
Status
N/A