Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in Healthy

A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Test Article or Placebo Administered Orally to Healthy and Osteoarthritis Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00380900

Enrollment

Unknown

Registered

2006-09-27

Start date

2006-07-31

Completion date

2007-02-28

Last updated

2007-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects, Osteoarthritis

Brief summary

The purpose of this study is to evaluate the safety and tolerbility of ascending multiple oral doses of AGG-523 in healthy subjects and in subjects with osteoarthritis.

Interventions

DRUGAGG-523

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy men or women, aged 18 to 40 years and subjects with osteoarthritis of the knee, aged 40 to 75 years. * Women must be of non-childbearing potential, defined as surgically sterile with documentation of ultrasound. * Must be nonsmoker or smoke less than 10 cigarettes per day.

Design outcomes

Primary

Measure	Time frame
Assess the safety of multiple doses of AGG-523 administered to subjects.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026