At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 104 enrolled
Drug / intervention
SHP681 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
- ✓Age 18-50 years at time of consent
- ✓Considered healthy with no active or chronic disease based on detailed medical/surgical history, physical exam, ECG, hematology, blood chemistry, and urinalysis
- ✓Body mass index 18.0-30.0 kg/m² with body weight 50-100 kg
Key exclusion· 11
- ✕History of hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, or conditions affecting drug absorption/disposition
- ✕Significant illness within 2 weeks of first dose
- ✕Known or suspected intolerance or hypersensitivity to investigational product or related compounds
- ✕Prior exposure to any GLP-2 analogs
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending, Subcutaneous, Single and Multiple Doses of SHP681 (GLP-2 Analog-Fc Fusion) in Healthy Adult Subjects
In Brief
A Phase 1 clinical trial evaluating SHP681 and Placebo for Healthy Volunteers. Completed, enrolled 104 participants across 1 site.
Detailed Summary
The purpose of the study is to assess the safety and tolerability of single and multiple ascending subcutaneous (SC) doses of SHP681 in healthy adult participants.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMar 2019
Enrollment StartMar 2019
Primary CompletionJan 2020
TodayJul 2026
First PostedMar 1, 2019
Enrollment StartMar 26, 2019
Primary CompletionJan 6, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.3 years ago
Interventions
SHP681drug
Participants will receive SC injection of SHP681 in the abdomen.
Placeboother
Participants will receive SC injection of placebo matched to SHP681 in the abdomen.