At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
rozanolixizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Participant-Blind, Investigator-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants
In Brief
A Phase 1 clinical trial evaluating rozanolixizumab and Placebo for Healthy Study Participants. Completed, enrolled 32 participants across 1 site.
Detailed Summary
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single subcutaneous (SC) dose of rozanolixizumab administered to healthy participants by manual push (MP) versus (vs) syringe driver.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Study Participants
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedApr 2021
Enrollment StartApr 2021
Primary CompletionApr 2022
TodayJul 2026
First PostedApr 2, 2021
Enrollment StartApr 22, 2021
Primary CompletionApr 11, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 5.3 years ago
Interventions
rozanolixizumabdrug
Study participants will receive a single dose rozanolixizumab subcutaneously administered by manual push or a syringe driver.
Placeboother
Study participants will receive a single dose placebo subcutaneously administered by manual push or a syringe driver.