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

• Status: Completed
• Trial end date: 2018-05-18
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eidos Therapeutics; Eidos Therapeutics, a BridgeBio company
• Collaborator: Celerion
• Treatments: Coal Tar

Criteria

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;