NCT06343714

A Study of FB1003 in Healthy Subject

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 Subjects
4B Technologies Limited·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Healthy Volunteers
Drug/Device/Intervention
FB1003
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
4B Technologies Limited
Timeline & enrollment
Phase
Phase 1
Start date
Apr 03, 2024
End date
Jun 30, 2025
Enrollment
64 participants
Primary outcome

The primary endpoint in the study is the incidence and severity of treatment emergent adverse events (TEAEs) in participants treated with FB1003 or placebo.

Summary

The purpose of this study 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.

ICD-10 classifications
Healthy person accompanying sick personRoutine general health check-up of armed forcesRoutine general health check-up of sports teamsRoutine general health check-up of inhabitants of institutions
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06343714
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06343714 through Pure Global AI's free database. This Phase 1 trial is sponsored by 4B Technologies Limited and is currently Not yet recruiting. The study focuses on Healthy Volunteers. Target enrollment is 64 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.