Status:
COMPLETED
Single and Multiple Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of AG10
Lead Sponsor:
Eidos Therapeutics, a BridgeBio company
Collaborating Sponsors:
Celerion
Conditions:
Amyloid Cardiomyopathy, Transthyretin-Related
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a single center, prospective, randomized, placebo-controlled study of AG10 in healthy adult subjects
Detailed Description
Up to 48 healthy volunteers will be given a single dose of AG10 or placebo and be monitored for safety and tolerability over a 5-day period. Up to 48 healthy volunteers will be given multiple doses of...
Eligibility Criteria
Inclusion
- Weight between \>50 kg and ≤110 kg;
- BMI of 18 to 32 kg/m2;
- Subjects who are healthy as determined by medical history, physical examination, 12 lead ECG and standard laboratory tests;
- Subjects who are negative for drugs of abuse and alcohol tests;
- Subjects who are non-smokers;
Exclusion
- Subjects who have used prescription drugs within 4 weeks of first dosing;
- Subjects who have a prior cholecystectomy;
- Subjects who have used any over-the-counter medications within 7 days prior to Day -1;
- Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders;
- Subjects who have an abnormal screening ECG;
Key Trial Info
Start Date :
September 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2018
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03294707
Start Date
September 11 2017
End Date
May 18 2018
Last Update
September 19 2024
Active Locations (1)
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1
Celerion
Tempe, Arizona, United States, 85283