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

Eidos Therapeutics

Status and phase

Completed

Phase 1

Conditions

Amyloid Cardiomyopathy, Transthyretin-Related

Treatments

Drug: Placebo Oral Tablet

Drug: AG10 oral tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT03294707

AG10-001

Details and patient eligibility

About

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

Full 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 AG10 or placebo and be monitored for safety and tolerability over a 15-day period.

Enrollment

56 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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;