Clinical Trials Directory

Trials / Unknown

UnknownNCT04404023

Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers

A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of a Single Dose of UB-221 in Healthy Volunteers

Status
Unknown
Phase
Phase 1
Study type
Interventional
Enrollment
15 (estimated)
Sponsor
UBP Greater China (Shanghai) Co., Ltd · Industry
Sex
All
Age
20 Years – 65 Years
Healthy volunteers
Accepted

Summary

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers.

Detailed description

This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics,and immunogenicity of a single dose of UB-221 in healthy volunteers.

Conditions

Interventions

TypeNameDescription
BIOLOGICALUB-221UB-221 (75 mg/ml)

Timeline

Start date
2023-12-01
Primary completion
2024-06-01
Completion
2025-06-01
First posted
2020-05-27
Last updated
2022-05-18

Source: ClinicalTrials.gov record NCT04404023. Inclusion in this directory is not an endorsement.