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

Sponsor

HI-Bio (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05928585

Collaborator

(none)

Enrollment

Location

Arms

8.9

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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:

Safe
Well tolerated
Does the body absorb and eliminate HIB210 as expected

Condition or Disease	Intervention/Treatment	Phase
Immune System Diseases Autoimmunity	Drug: HIB210 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 6, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MAD HIB210 Increasing doses of HIB210 will be administered for cohorts 1-4 in a multiple ascending dose format	Drug: HIB210 Experimental monoclonal antibody
Placebo Comparator: MAD Placebo Placebo will be administered for cohorts 1-4 in a multiple ascending dose format	Drug: Placebo Placebo

Arm

Intervention/Treatment

Experimental: MAD HIB210

Increasing doses of HIB210 will be administered for cohorts 1-4 in a multiple ascending dose format

Drug: HIB210

Experimental monoclonal antibody

Placebo Comparator: MAD Placebo

Placebo will be administered for cohorts 1-4 in a multiple ascending dose format

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

Number of participants with adverse events [Baseline to End of Study (Up to Day 114)]
Number of participants with clinical laboratory abnormalities [Baseline to End of Study (Up to Day 114)]
Number of participants with electrocardiogram (ECG) abnormalities [Baseline to End of Study (Up to Day 114)]
Number of participants with physical examination abnormalities [Baseline to End of Study (Up to Day 114)]
Number of participants with vital sign abnormalities [Baseline to End of Study (Up to Day 114)]

Secondary Outcome Measures

PK Parameters: Cmax [Baseline to Day 29]
Maximum Serum Concentration (Cmax)
PK Parameters: tmax [Baseline to Day 29]
Time to Maximum Serum Concentration (tmax)
PK Parameters: AUC [Baseline to Day 29]
Area under the serum concentration-time curve
Anti-drug Antibodies (ADA) [Baseline to End of Study (Up to Day 114)]
Baseline prevalence and post-dose incidence of ADA

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HI-Bio Investigational Site	Hialeah	Florida	United States	33014

Sponsors and Collaborators

HI-Bio

Investigators

Study Director: HI-Bio Clinical Program Lead, HI-Bio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

HI-Bio

ClinicalTrials.gov Identifier:

NCT05928585

Other Study ID Numbers:

HIB-210-101

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 7, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by HI-Bio

Additional relevant MeSH terms:

Immune System Diseases

Study Results

No Results Posted as of Jul 7, 2023