A Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Participants

A Single-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3000328 in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01515358

Enrollment

Registered

2012-01-24

Start date

2012-02-29

Completion date

2012-05-31

Last updated

2012-05-31

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

Conditions

Healthy Volunteers

Brief summary

The purposes of this study are to determine the safety and side effects of LY3000328, to determine how well the body will tolerate LY3000328, and to determine how long LY3000328 remains in the body.

Interventions

DRUGPlacebo

Administered orally

DRUGLY3000328

Administered orally

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Are overtly healthy males or females, as determined by medical history and physical examination

Design outcomes

Primary

Measure	Time frame
Number of participants with one or more drug related adverse events (AEs) or any serious AEs	Baseline to study completion (estimate 3 months)

Secondary

Measure	Time frame
Pharmacokinetics: Area under the concentration-time curve (AUC) of LY3000328	Pre-dose up to Day 6 post-dose
Pharmacokinetics: Maximum concentration (Cmax) of LY3000328	Pre-dose up to Day 6 post-dose
Change in Cathepsin S (CatS) activity	Pre-dose, up to 48 hours post-dose

Countries

Singapore

Outcome results

None listed

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