Single and Multiple Ascending Dose Study Assessing the Safety, Tolerability, PK and PD of AG10
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 5/25/2018 |
Start Date: | September 11, 2017 |
End Date: | May 18, 2018 |
A Phase 1 Randomized, Placebo-controlled, Single and Multiple Ascending Dose Study of the Tolerability, Pharmacokinetics and Pharmacodynamics of AG10 in Healthy Subjects
This is a single center, prospective, randomized, placebo-controlled study of AG10 in healthy
adult subjects
adult subjects
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.
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.
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;
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