Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02271412

Enrollment

Registered

2014-10-22

Start date

2014-10-31

Completion date

2015-03-31

Last updated

2015-10-21

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

Conditions

Major Depressive Disorder, Recurrent, Unspecified

Brief summary

Objectives * To evaluate the safety and tolerability of escalating multiple oral doses of LY03005 in healthy subjects. * To characterize the pharmacokinetics of escalating multiple oral doses of LY03005.

Detailed description

This will be a randomized, double-blind, placebo-controlled, multiple ascending dose study to be conducted in the US. Approximately 48 healthy subjects will be enrolled into one of the four groups

Interventions

DRUGLY03005

LY03005 is a new investigational pro-drug of desvenlafaxine formulated as extended-release oral tablets for the treatment of major depressive disorder.

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1. Are capable of giving informed consent and complying with study procedures; 2. Are between the ages of 18 and 45 years, inclusive; 3. A negative pregnancy test result prior to screening and admission for all female subjects, and meet the following criteria defined as: 1. If child-bearing potential, agree to avoid pregnancy during the study and one month after the end of the study by using effective contraceptive method(s), such as an intrauterine device (IUD), diaphragm with spermicide, and condoms with spermicide. 2. Surgically sterile for at least 3 months prior to screening 3. Postmenopausal 4. Considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs; 5. Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 months before screening; 6. Body mass index (BMI) of 19 to 30 kg/m2 inclusive and body weight not less than 50 kg; 7. Willing and able to adhere to study restrictions and to be confined at the clinical research center.

Exclusion criteria

Subjects will be excluded from study entry if any of the following

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Adverse Events	3 to 4 months	Safety and Tolerability of LY03005

Countries

United States

Outcome results

None listed

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