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

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: HI-Bio

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