Immune System DiseasesPhase 1NCT05928585
A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers
A Phase 1 study testing HIB210 in people with Immune System Diseases and Autoimmunity, run by HI-Bio, A Biogen Company at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System Diseases, Autoimmunity
- What is being tested?
- HIB210
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2023to 10 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HIB210 in Healthy Volunteers
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
- Immune System Diseases, Autoimmunity
- Being tested
- HIB210, Placebo
- Keywords
- C5aR1, C5a receptor, C5aR1 inhibition, CD88
- Medical subject headings
- Immune System Diseases, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIB210Drug
Experimental monoclonal antibody
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MAD HIB210 | Experimental | Increasing doses of HIB210 will be administered for cohorts 1-4 in a multiple ascending dose format Receives: Drug: HIB210 |
| MAD Placebo | Placebo comparator | Placebo will be administered for cohorts 1-4 in a multiple ascending dose format Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: Baseline to End of Study (Up to Day 114)
Number of participants with clinical laboratory abnormalities
Measured: Baseline to End of Study (Up to Day 114)
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Baseline to End of Study (Up to Day 114)
Number of participants with physical examination abnormalities
Measured: Baseline to End of Study (Up to Day 114)
Number of participants with vital sign abnormalities
Measured: Baseline to End of Study (Up to Day 114)
Secondary outcomes (4)
PK Parameters: Cmax
Maximum Serum Concentration (Cmax)
Measured: Baseline to Day 29
PK Parameters: tmax
Time to Maximum Serum Concentration (tmax)
Measured: Baseline to Day 29
PK Parameters: AUC
Area under the serum concentration-time curve
Measured: Baseline to Day 29
Anti-drug Antibodies (ADA)
Baseline prevalence and post-dose incidence of ADA
Measured: Baseline to End of Study (Up to Day 114)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start6 Jul 2023
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune System DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- HI-Bio, A Biogen Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, HI-Bio, A Biogen Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928585
- Sponsor's protocol ID
- HIB-210-101
- Status last verified
- Feb 2025
- First submitted
- 12 Jun 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HIB210 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05928585
- Acronym / sponsor ID
- HIB-210-101
- Conditions
- Immune System Diseases, Autoimmunity
- Keywords
- C5aR1, C5a receptor, C5aR1 inhibition, CD88
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- HI-Bio, A Biogen CompanyIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAD HIB210 | Experimental | Drug: HIB210Increasing doses of HIB210 will be administered for cohorts 1-4 in a multiple ascending dose format |
| MAD Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered for cohorts 1-4 in a multiple ascending dose format |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIB210Experimental monoclonal antibody | Drug | MAD HIB210 |
| PlaceboPlacebo | Drug | MAD Placebo |
Primary outcome
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)
4 secondary outcomes
PK Parameters: Cmax
Time frame: Baseline to Day 29
PK Parameters: tmax
Time frame: Baseline to Day 29
PK Parameters: AUC
Time frame: Baseline to Day 29
Anti-drug Antibodies (ADA)
Time frame: Baseline to End of Study (Up to Day 114)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
HI-Bio, A Biogen Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HIB210 in people with Immune System Diseases and Autoimmunity, run by HI-Bio, A Biogen Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Baseline to End of Study (Up to Day 114)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.