Back to resultsA Study of Safety and Drug Levels of HIB210 in Healthy Volunteers
Primary Purpose
Immune System Diseases, Autoimmunity
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HIB210
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Immune System Diseases focused on measuring C5aR1, C5a receptor, C5aR1 inhibition, CD88
Eligibility Criteria
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
Sites / Locations
- HI-Bio Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
MAD HIB210
MAD Placebo
Arm Description
Increasing doses of HIB210 will be administered for cohorts 1-4 in a multiple ascending dose format
Placebo will be administered for cohorts 1-4 in a multiple ascending dose format
Outcomes
Primary Outcome Measures
Number of participants with adverse events
Number of participants with clinical laboratory abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
Number of participants with physical examination abnormalities
Number of participants with vital sign abnormalities
Secondary Outcome Measures
PK Parameters: Cmax
Maximum Serum Concentration (Cmax)
PK Parameters: tmax
Time to Maximum Serum Concentration (tmax)
PK Parameters: AUC
Area under the serum concentration-time curve
Anti-drug Antibodies (ADA)
Baseline prevalence and post-dose incidence of ADA
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05928585
Brief Title
A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers
Official Title
Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HIB210 in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HI-Bio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune System Diseases, Autoimmunity
Keywords
C5aR1, C5a receptor, C5aR1 inhibition, CD88
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MAD HIB210
Arm Type
Experimental
Arm Description
Increasing doses of HIB210 will be administered for cohorts 1-4 in a multiple ascending dose format
Arm Title
MAD Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administered for cohorts 1-4 in a multiple ascending dose format
Intervention Type
Drug
Intervention Name(s)
HIB210
Intervention Description
Experimental monoclonal antibody
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of participants with adverse events
Time Frame
Baseline to End of Study (Up to Day 114)
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Baseline to End of Study (Up to Day 114)
Title
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame
Baseline to End of Study (Up to Day 114)
Title
Number of participants with physical examination abnormalities
Time Frame
Baseline to End of Study (Up to Day 114)
Title
Number of participants with vital sign abnormalities
Time Frame
Baseline to End of Study (Up to Day 114)
Secondary Outcome Measure Information:
Title
PK Parameters: Cmax
Description
Maximum Serum Concentration (Cmax)
Time Frame
Baseline to Day 29
Title
PK Parameters: tmax
Description
Time to Maximum Serum Concentration (tmax)
Time Frame
Baseline to Day 29
Title
PK Parameters: AUC
Description
Area under the serum concentration-time curve
Time Frame
Baseline to Day 29
Title
Anti-drug Antibodies (ADA)
Description
Baseline prevalence and post-dose incidence of ADA
Time Frame
Baseline to End of Study (Up to Day 114)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HI-Bio Clinical Program Lead
Phone
1-408-548-7261
Email
clinicaltrialdisclosure@hibio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HI-Bio Clinical Program Lead
Organizational Affiliation
HI-Bio
Official's Role
Study Director
Facility Information:
Facility Name
HI-Bio Investigational Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data supporting this study are not publicly available due to the ongoing nature of the clinical development program. Datasets may be available upon reasonable request 18 months after the final clinical study report has been completed and, as appropriate, once the regulatory review of the indication or drug has completed, whichever is later.
Learn more about this trial
A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers
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