A Study to Evaluate the Safety and Pharmacokinetics of BX-001N in Healthy Participants

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled, single and multiple ascending dose, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of BX-001N after intravenous administration in approximately 64 healthy participants

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

Details

• Lead Sponsor: Bilix Co.,Ltd.

Criteria

Inclusion Criteria:

• 18 to 50 years of age

• In good general health at Screening and/or before the first administration of IP

• BMI > 18.0 and < 32.0 kg/m2 at Screening

• Nonsmoker and must not have used any tobacco products within 2 months prior to screening

• Females must not be pregnant or lactating, and females and males must use acceptable, highly effective double contraception during study and follow-up period

• Person who can provide written informed consent prior to the commencement of all study procedures

Exclusion Criteria:

• Underlying physical or psychological medical condition to comply with the protocol or complete the study per protocol

• Genetic disorder with severe and abnormal bilirubin metabolism

• Blood or plasma donation or significant blood loss prior to the first administration of IP

• Viral or bacterial infection prior to the first administration of IP

• Poor venous access

• Significant scarring or tattoos at the planned site of IP administration

• History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents

• History or active cardiovascular, respiratory, kidney, endocrine, blood, digestive, central nervous, urinary and/or musculoskeletal disease

• History of malignancy prior to Screening

• Abnormal ECG findings

• History or presence of a condition associated with significant immunosuppression

• History of life-threatening infection

• Infections requiring parenteral antibiotics

• Vaccination prior to the first administration of IP

• Exposure to any significantly immune suppressing drug

• Abnormal vital signs findings

• Abnormal laboratory findings

• Positive results for viral testing at Screening

• Positive result at Screening and Day -1 for toxicology screening panel

• History of substance abuse or dependency or history of recreational intravenous (IV) drug use

• Excess of regular alcohol consumption

• Use of any IP or investigational medical device within 30 days prior to Screening

• Unable to adhere to the prohibited therapies

• Unwilling to adhere to the dietary restrictions

• Unwilling to refrain from strenuous exercise