A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
Amgen
Summary
The main objective of this trial is to assess the safety and tolerability of AMG 127 as single dose and multiple doses in healthy participants and participants with type 2 diabetes mellitus (T2DM).
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria for Part A and B * Participant must be 18-65 years of age * Participant must be overtly healthy Inclusion Criteria for Part C * Participant must be 40-75 years of age * Confirmed diagnoses of T2DM Exclusion Criteria for Part A and B * History of hypotension, syncope, or orthostatic intolerance * Systolic blood pressure \>140 millimeters of mercury (mmHg) or diastolic blood pressure \>90 mmHg Exclusion Criteria for Part C * Hemoglobin A1c (HbA1c) \>10% within the last 3 months * History of hypotension, syncope, or orthostatic intolerance * Systolic blood pressure \>160…
Interventions
- DrugAMG 127
AMG127 will be administered as either a SC injection or as an IV infusion.
- DrugPlacebo
Placebo will be administered as either a SC injection or as an IV infusion.
Location
- Translational Clinical Research LLCAventura, Florida