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

HI-Bio, A Biogen Company

Status and phase: Completed; Phase 1

Conditions: Autoimmunity; Immune System Diseases

Treatments: Drug: HIB210; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05928585

HIB-210-101

Details and patient eligibility

About

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

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

MAD HIB210

Experimental group

Description:

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

Treatment:

Drug: HIB210

MAD Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo