A Study of CAT-1004 Biomarkers in Healthy Subjects

A Phase 1, Single Center, Biomarker Study in Healthy Subjects Receiving Single Doses of CAT-1004

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01670773

Enrollment

Registered

2012-08-22

Start date

2012-08-31

Completion date

2012-10-31

Last updated

2012-10-30

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

Conditions

Assessment of Mechanistic Blood Biomarkers in Healthy Humans

Brief summary

This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy humans.

Interventions

DRUGCAT-1004

DRUGSalsalate + DHA

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Good health as determined by medical history, vital signs, EGC, physical exam and clinical lab results * BMI between 18 and 30 kg/m2 inclusive

Exclusion criteria

* Viral or bacterial infection within 21 days prior to randomization * Use of prescription drugs, nonprescription drugs, herbals and dietary supplements within 7 days prior to randomization

Design outcomes

Primary

Measure	Time frame
Change in nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) activity p65 following ex vivo lipopolysaccharide stimulation	Pre/post each of 3 Single doses

Other

Measure	Time frame
Other biomarkers including select cytokines and RNA gene expression may also be assessed	Pre/post each of 3 Single doses

Countries

United States

Outcome results

None listed

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