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Evaluate the Safety, Tolerability, Pharmacokinetics,and Clinical Activity of FB704A

NCT03890302 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-07-21

No results posted yet for this study

Summary

The cause of Rheumatoid Arthritis (RA) is not fully understood. However, one of the substances secreted by certain cells in the body, interleukin-6 (IL-6), is believed to play a major role in chronic inflammation that is typical in RA. This study investigates the drug FB704A, which is believed to lower the inflammation caused by IL-6. This study will be in 2 sequential parts: a single increasing dose part (Part 1) and a multiple-increasing dose part (Part 2). Subjects will receive either active or placebo drug by IV infusion. Subjects in both parts will have a short stay in the clinic at the start of the study, then will return for outpatient visits.

Conditions

Interventions

DRUG

FB704A

Administered by IV infusion

DRUG

Placebo

Identical in appearance and same excipients as FB704A, but without active compound. Administered by IV infusion

Sponsors & Collaborators

  • Oneness Biotech Co., Ltd.

    collaborator INDUSTRY

  • Fountain Biopharma Inc.

    lead INDUSTRY

Principal Investigators

  • Martin Kankam, MD · Altasciences Clinical Kansas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-14
Primary Completion
2020-05-27
Completion
2020-05-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03890302 on ClinicalTrials.gov