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HIB210 Safety and Drug Levels Study in Healthy Volunteers

Phase 1
Recruiting
Research Sponsored by HI-Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of study (up to day 114)
Awards & highlights

Study Summary

This trial tests if an investigational product is safe and well-tolerated when taken as multiple doses, and if the body absorbs and eliminates it properly.

Who is the study for?
Healthy adults aged 19-65 with no major health issues, recent surgeries, or significant infections can join this trial. They should have a BMI between 18 and 32 kg/m2, no history of cancer except for certain skin cancers or limited cervical cancer, and must follow the study's birth control rules.Check my eligibility
What is being tested?
The trial is testing HIB210 to see if it's safe when given in multiple doses to healthy people. It will also check how well participants tolerate it and how their bodies absorb and get rid of the drug.See study design
What are the potential side effects?
Since this is an early-stage trial to test safety, specific side effects are not yet known. However, common risks may include injection site reactions, allergic responses, headaches, nausea or other general discomforts.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of study (up to day 114)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of study (up to day 114) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events
Number of participants with clinical laboratory abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
+2 more
Secondary outcome measures
Anti-drug Antibodies (ADA)
PK Parameters: AUC
PK Parameters: Cmax
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MAD HIB210Experimental Treatment1 Intervention
Increasing doses of HIB210 will be administered for cohorts 1-4 in a multiple ascending dose format
Group II: MAD PlaceboPlacebo Group1 Intervention
Placebo will be administered for cohorts 1-4 in a multiple ascending dose format

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

HI-BioLead Sponsor
5 Previous Clinical Trials
151 Total Patients Enrolled
HI-Bio Clinical Program LeadStudy DirectorHI-Bio
4 Previous Clinical Trials
129 Total Patients Enrolled

Media Library

MAD HIB210 Clinical Trial Eligibility Overview. Trial Name: NCT05928585 — Phase 1
Autoimmune Disorder Research Study Groups: MAD HIB210, MAD Placebo
Autoimmune Disorder Clinical Trial 2023: MAD HIB210 Highlights & Side Effects. Trial Name: NCT05928585 — Phase 1
MAD HIB210 2023 Treatment Timeline for Medical Study. Trial Name: NCT05928585 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Might I be eligible to take part in this clinical trial?

"To be eligible for entry into this clinical trial, an individual must have immune system disorders and fall within the 19-65 age range. The team is aiming to enroll 32 participants in total."

Answered by AI

Does this clinical trial enlist individuals of the age 45 and above?

"This medical trial requires patients to be between the ages of 19 and 65 in order to participate. Alternatively, there are 13 studies for younger individuals and 20 trials for those over senior citizen age."

Answered by AI

Is there still enrollment capacity for this trial?

"This trial, with its inception being on June 1st 2023 and its last update occurring 21 days later on the 22nd of June, is not currently recruiting participants. However, 27 other studies are actively opening their arms to new patients at present."

Answered by AI

What are the foremost ambitions of this trial?

"HI-Bio, the trial's sponsor, has specified that the primary outcome of this study will be ascertained from Baseline to End of Study (Up to Day 114). This is a measure of Number of participants with clinical laboratory abnormalities. Additionally, secondary outcomes such as PK Parameters: tmax (Time to Maximum Serum Concentration), PK Parameters: AUC (Area under the serum concentration-time curve) and Anti-drug Antibodies (ADA)(Baseline prevalence and post-dose incidence of ADA) are also being evaluated."

Answered by AI

Has the FDA sanctioned MAD HIB210 for commercial use?

"Due to the limited data from this Phase 1 trial, MAD HIB210 is rated cautiously as a score of 1 in terms of safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers
2023. "A Study of Safety and Drug Levels of HIB210 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05928585.
~18 spots leftby Apr 2025
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