CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 190 enrolled
Drug / intervention
SHP643drug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Age 18-55 years at time of consent
  • ✓Considered healthy by investigator with no active or chronic disease confirmed by medical history, physical exam, vital signs, ECG, hematology, blood chemistry, and urinalysis
  • ✓BMI 18.5-33 kg/m² with body weight ≥45 kg
  • ✓Systolic BP 89-139 mmHg and diastolic BP 49-89 mmHg
Key exclusion· 10
  • ✕History of hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, or gall bladder removal
  • ✕Significant illness within 2 weeks prior to dosing
  • ✕Known history of alcohol or substance abuse within the last year
  • ✕Blood donation within 60 days prior to dosing

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03918239
NCT03918239Phase 1Completed
CompareCT.gov

A Randomized, Open-label, Single-dose, Parallel-arm, Single-center, Phase 1 Study to Determine the Bioavailability of Lanadelumab Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Subjects

Shire·interventional·Posted Apr 17, 2019·Updated Dec 8, 2020

In Brief

A Phase 1 clinical trial evaluating SHP643 for Healthy Volunteers. Completed, enrolled 190 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate bioavailability of lanadelumab (SHP643) following a single, 2 milliliter (mL) subcutaneous (SC) dose of 300 milligrams (mg) delivered by prefilled syringe (PFS) or auto injector (AI) in healthy adult participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedApr 17, 2019
Enrollment StartMay 14, 2019
Primary CompletionNov 13, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.2 years ago

Interventions

SHP643drug

Participants will receive injection of SHP643.