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RECRUITING
NCT06343714
PHASE1

A Study of FB1003 in Healthy and Osteoarthritis Pain Subjects

Sponsor: 4B Technologies Limited

View on ClinicalTrials.gov

Summary

The purpose of Part 1 is to evaluate safety and tolerability of FB1003 when given subcutaneously to healthy participants. Blood tests will be done to examine blood exposure, concentration and half-life of FB1003 following administrations. For each participant, the study will last up to about 12 weeks for single ascending dose part, and 18 weeks for multiple ascending dose part, including screening. The purpose of Part 2 is to assess the safety, tolerability, PK and efficacy of SAD of SC administered FB1003 in adult subjects with osteoarthritis (OA) pain.

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Escalating Single and Multiple Doses of FB1003 in the Healthy and Osteoarthritis Pain Subjects

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2024-04-07

Completion Date

2026-05-30

Last Updated

2025-06-15

Healthy Volunteers

Yes

Interventions

DRUG

FB1003

Subcutaneous (SC) injection

DRUG

Placebo

Subcutaneous (SC) injection

Locations (2)

Nucleus Network

Brisbane, Queensland, Australia

Veritus Research

Bayswater, Victoria, Australia