CompletedNCT05928585Updated Feb 7, 2025

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

A Phase 1 interventional study of HIB210 and Placebo in Immune System Diseases and Autoimmunity, sponsored by HI-Bio, A Biogen Company. Completed at 1 site in United States. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-07.

Sponsored by HI-Bio, A Biogen Company (part of Biogen) · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Jun 2024, 2 years 4 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 19 Years to 65 Years
Sex: All

Study 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

Read the detailed description

Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.

Conditions studied

Immune System Diseases
Autoimmunity

Browse trials for

Keywords

C5aR1
C5a receptor
C5aR1 inhibition
CD88

In context

Immune System Diseases

288 studies on the registry are indexed under Immune System Diseases; 80 are open to participants now.

This study's enrollment of 30 is below the median of 71 across 194 interventional studies indexed under Immune System Diseases.

Browse Immune System Diseases studies →

Lead sponsor

HI-Bio, A Biogen Company is the lead sponsor of 5 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

First submitted before HI-Bio became part of Biogen.

Browse HI-Bio studies →All Biogen studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 30 participants (actual)

Study arms

Experimental
MAD HIB210
Increasing doses of HIB210 will be administered for cohorts 1-4 in a multiple ascending dose format
Drug: HIB210
Placebo comparator
MAD Placebo
Placebo will be administered for cohorts 1-4 in a multiple ascending dose format
Drug: Placebo

Interventions

DrugHIB210
Experimental monoclonal antibody
DrugPlacebo
Placebo

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

HI-Bio Investigational Site
Hialeah, Florida 33014, United States

References and documents

Individual participant data

Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2023 to primary completion in Jun 2024, 11 months.

Of 31 phase 1 interventional studies under Immune System Diseases, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 77. This study's 11 months is below that.

Immune System Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 12, 2023
First posted: Jul 3, 2023
StartActual: Jul 6, 2023
Primary completionActual: Jun 10, 2024
CompletionActual: Jun 10, 2024
Last update: Feb 7, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Feb 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05928585
Lead sponsor: HI-Bio, A Biogen Company
Responsible party: Sponsor
First posted: Jul 3, 2023
Start date: Jul 6, 2023
Primary completion: Jun 10, 2024
Completion: Jun 10, 2024
Last update: Feb 7, 2025

Study contacts

Medical Director

study director · HI-Bio, A Biogen Company

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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