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

NCT05928585 | Completed Phase 1 FDA Drug

• 1 other identifier: HIB-210-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

1. 1.Safe
2. 2.Well tolerated
3. 3.Does the body absorb and eliminate HIB210 as expected

Conditions

Immune System Diseases; Autoimmunity

Keywords

C5aR1; C5a receptor; C5aR1 inhibition; CD88

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• PK Parameters: Cmax

  Baseline to Day 29

• PK Parameters: tmax

  Baseline to Day 29

• PK Parameters: AUC

  Baseline to Day 29

• Anti-drug Antibodies (ADA)

  Baseline to End of Study (Up to Day 114)

Study Arms (2)

MAD HIB210

EXPERIMENTAL

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

Drug: HIB210

MAD Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

HIB210 DRUG

Experimental monoclonal antibody

MAD HIB210

Placebo DRUG

Placebo

MAD Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• HI-Bio, A Biogen Company: lead

Study Sites (1)

HI-Bio Investigational Site

Hialeah, Florida, 33014, United States

Location

MeSH Terms

Conditions

Immune System Diseases; Autoimmune Diseases

Study Officials

• Medical Director

  HI-Bio, A Biogen Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 3, 2023
• Study Start: July 6, 2023
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)