A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers

Immune System Diseases Clinical Trial

Official title:

Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HIB210 in Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928585
• Other study ID #: HIB-210-101
• Status: Recruiting
• Phase: Phase 1
• Start date: July 6, 2023
• Est. completion date: April 2024

Study information

• Verified date: September 2023
• Source: HI-Bio
• Contact: HI-Bio Clinical Program Lead
• Phone: 1-408-548-7261
• Email: clinicaltrialdisclosure[@]hibio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to test safety of the investigational product in healthy volunteers. The main questions it aims to answer is when HIB210 is administered as multiple doses, is it:

1. Safe

2. Well tolerated

3. Does the body absorb and eliminate HIB210 as expected

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Key Eligibility Criteria:

• Healthy male and females between 19 to 65 years of age

• Normal or not significantly abnormal laboratory tests and EKG findings during Screening

• No significant medical conditions that might affect ability to participate in the study or present a safety risk

• No evidence of significant or recurrent infection or recent infection

• No history of cancer other than certain skin cancers and limited cancer of the cervix of the womb

• Willingness to comply with birth control requirements of the study (for both men and women)

• No recent major surgery or trauma or planned surgery during the study or within 1 month after the study

• Body mass index (BMI) between 18 and 32 kg/m2

Related Conditions & MeSH terms

• Autoimmunity
• Immune System Diseases

Intervention

Drug:
• HIB210
Experimental monoclonal antibody
• Placebo
Placebo

Locations

Country	Name	City	State
United States	HI-Bio Investigational Site	Hialeah	Florida

Sponsors (1)

Lead Sponsor	Collaborator
HI-Bio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		Baseline to End of Study (Up to Day 114)
Primary	Number of participants with clinical laboratory abnormalities		Baseline to End of Study (Up to Day 114)
Primary	Number of participants with electrocardiogram (ECG) abnormalities		Baseline to End of Study (Up to Day 114)
Primary	Number of participants with physical examination abnormalities		Baseline to End of Study (Up to Day 114)
Primary	Number of participants with vital sign abnormalities		Baseline to End of Study (Up to Day 114)
Secondary	PK Parameters: Cmax	Maximum Serum Concentration (Cmax)	Baseline to Day 29
Secondary	PK Parameters: tmax	Time to Maximum Serum Concentration (tmax)	Baseline to Day 29
Secondary	PK Parameters: AUC	Area under the serum concentration-time curve	Baseline to Day 29
Secondary	Anti-drug Antibodies (ADA)	Baseline prevalence and post-dose incidence of ADA	Baseline to End of Study (Up to Day 114)