An open-label, single ascending dose study to evaluate the safety and pharmacokinetics of a tablet formulation of CG-549 in healthy subjects

Completed

• Conditions: bacterial infections; 10004018

• Registration Number: NL-OMON48209
• Lead Sponsor: CrystalGenomics, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Sex: male or female; females may be of childbearing potential or of
nonchildbearing potential (i.e., either surgically sterilized, physiologically
incapable of becoming pregnant, or at least 1 year postmenopausal [amenorrhea
duration of 12 consecutive months and a serum follicle stimulating hormone
(FSH) >33.4 IU/L]).
2. Age: 18 to 55 years, inclusive, at screening.
3. Body mass index (BMI): 18.0 to 30.0 kg/m2, inclusive, at screening.
4. Weight: >=50 kg at screening.
5. Status: healthy subjects.

Exclusion Criteria

1. Previous participation in the current study.
2. Employee of PRA or the Sponsor.
3. History of bacterial or viral infection requiring treatment with antibiotics
or antivirals within 1 month prior to screening.
4. Presence or history of esophageal or gastroduodenal ulceration within 1
month prior to screening.
5. History of diseases or abnormalities of the liver or biliary system, other
than uncomplicated hepatitis A.

Study & Design

• Study Type: Interventional
• Study Design: Not specified