Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HIB210 in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- HI-Bio, A Biogen Company
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of participants with clinical laboratory abnormalities
Study Overview
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
Detailed Description
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
MAD HIB210
Increasing doses of HIB210 will be administered for cohorts 1-4 in a multiple ascending dose format
Intervention: HIB210 (Drug)
MAD Placebo
Placebo will be administered for cohorts 1-4 in a multiple ascending dose format
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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 vital sign 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 adverse events
Time Frame: Baseline to End of Study (Up to Day 114)
Secondary Outcomes
- PK Parameters: tmax(Baseline to Day 29)
- Anti-drug Antibodies (ADA)(Baseline to End of Study (Up to Day 114))
- PK Parameters: Cmax(Baseline to Day 29)
- PK Parameters: AUC(Baseline to Day 29)