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

Use our guide to learn which trials are right for you!

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

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.

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;
We found this trial at
1
site
Tempe, Arizona 85283
Phone: 602-437-0097
?
mi
from
Tempe, AZ
Click here to add this to my saved trials