Single and Multiple Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of AG10

Completed · Phase 1 · Has a placebo group

Conditions studied: Amyloid Cardiomyopathy, Transthyretin-Related

In brief

This is a single center, prospective, randomized, placebo-controlled study of AG10 in healthy adult subjects

Key facts

Study ID

NCT03294707

Run by

Eidos Therapeutics, a BridgeBio company

People needed

56

Starts

2017-09-11

Expected to finish

2018-05-18

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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;

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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