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A Study to Evaluate the Safety and Bridging PK Profile of FB825 for Single Subcutaneous Administration in Healthy Adults

NCT05952986 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-01-26

No results posted yet for this study

Summary

This is a randomized, placebo-controlled, and double-blind study to evaluate the safety and bridging PK profile of FB825 for single SC administration in healthy adults.

Conditions

Interventions

DRUG

FB825 or Placebo in subcutaneous route

FB825 or placebo solution for SC injection

DRUG

FB825 in intravenous route

FB825 solution for IV infusion

Sponsors & Collaborators

  • Oneness Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-05-03
Primary Completion
2024-03-26
Completion
2024-03-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT05952986 on ClinicalTrials.gov