TEST for UAT Engage 6/24/24 Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects
Study identifier:ALXN1720-HV-101
ClinicalTrials.gov identifier:NCT04920370
EudraCT identifier:2018-004500-19
CTIS identifier:N/A
Study Complete
Official Title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
ALXN1720 SC, ALXN1720 IV, rHuPH20, Placebo SC, Placebo IV
Sex
All
Actual Enrollment
97
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 04 Sept 2019
Primary Completion Date: 16 Nov 2021
Study Completion Date: 16 Nov 2021
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2024 by Alexion Pharmaceuticals
Sponsors
Alexion Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: ALXN1720 Single Dose SC Participants will receive a single dose of ALXN1720 SC. | Drug: ALXN1720 SC ALXN1720 will be administered via SC route. |
| Experimental: ALXN1720 Multiple Dose SC Participants will receive multiple doses of ALXN1720 SC. | Drug: ALXN1720 SC ALXN1720 will be administered via SC route. |
| Experimental: ALXN1720 Single Dose SC + rHuPH20 Participants will receive a single dose of ALXN1720 SC in combination with rHuPH20. | Drug: ALXN1720 SC ALXN1720 will be administered via SC route. Drug: rHuPH20 rHuPH20 will be administered via SC route. |
| Experimental: ALXN1720 Single Dose IV Participants will receive a single dose of ALXN1720 IV. | Drug: ALXN1720 IV ALXN1720 will be administered via IV route. |
| Placebo Comparator: Placebo Participants will receive Placebo SC or Placebo IV according to their assigned cohort. | Drug: Placebo SC Placebo will be administered via SC route. Drug: Placebo IV Placebo will be administered via IV route. |
