A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmakinetics of BX-001N After Intravenous Bolus in Healthy Participants
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
This study comprises of 2 parts:
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Part 1- Single Ascending Dose (SAD)- This part will enroll approximately 40 participants across 5 cohorts where each participant will receive a single intravenous (IV) bolus dose in healthy participants. On Day 1, participants in each cohort will receive investigational product (IP) (i.e., BX-001N or Placebo) as a single IV bolus following a minimum 8-hour fast.
-
Part 2 -Multiple Ascending Dose (MAD)- This part will enroll approximately 24 participants across 3 cohorts where each participants will receive intravenous (IV) bolus dose for 7 sequential daily. At the same time each morning from Day 1 to Day 7 (inclusive), participants in each cohort will receive IP (i.e., BX-001N or Placebo) as a single IV bolus following a minimum 8-hour fast.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BX-001N Part 1 Part 1 is SAD with 5 cohorts where each participant will receive single IV bolus following a 8hr fast. |
Drug: BX-001N Part 1
Dosage form- IV bolus Dosage- In the five cohorts, each participant receives a single IV bolus administration in one of the five doses based on body weight and followed up for 7 days.
|
| Experimental: BX-001N Part 2 Part 2 is MAD with 3 cohorts where each participant will receive 7 sequential daily IV bolus doses following a 8hr fast. |
Drug: BX-001N Part 2
Dosage form- IV bolus Dosage- In the three cohorts, each participant receives a single IV bolus administration for 7 sequential days in one of the three doses based on body weight.
|
| Placebo Comparator: Placebo Matching doses of placebo |
Drug: Placebo
Participants will receive matching placebo across Part 1 and 2 of the study.
|
Outcome Measures
Primary Outcome Measures
- Number of participants with Treatment emergent Adverse events (TEAEs) [SAD-Screening to Day 7; MAD- Screening to Day 14]
TEAE will be collected to assess participants' safety after BX-001N treatment
- Number of participants with clinical laboratory abnormalities [SAD-Screening to Day 7; MAD- Screening to Day 14]
- Number of participants with changes in the 12-lead electrocardiogram (ECG) [SAD-Screening to Day 7; MAD- Screening to Day 14]
- Number of incidences of injection site reactions [SAD-Day 1 to Day 2; MAD- Day 1 to Day 8]
Secondary Outcome Measures
- PK Parameters: Maximum Concentration (Cmax) [SAD's samples of PK are collected at total 12 time points from pre-dose and up to Day 3 after dosing. MAD's samples of PK are collected at total 26 time points from pre-dose and up to Day 8 after dosing.]
- PK Parameters: Time of maximum Concentration (Tmax) [SAD's samples of PK are collected at total 12 time points from pre-dose and up to Day 3 after dosing. MAD's samples of PK are collected at total 26 time points from pre-dose and up to Day 8 after dosing.]
- PK Parameters: Area under curve (AUC) [SAD's samples of PK are collected at total 12 time points from pre-dose and up to Day 3 after dosing. MAD's samples of PK are collected at total 26 time points from pre-dose and up to Day 8 after dosing.]
- Immunogenicity- Anti-drug antibody (ADA) [SAD-Day 1 to Day 7; MAD- Screening to Day 14]
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 to 50 years of age
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In good general health at Screening and/or before the first administration of IP
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BMI > 18.0 and < 32.0 kg/m2 at Screening
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Nonsmoker and must not have used any tobacco products within 2 months prior to screening
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Females must not be pregnant or lactating, and females and males must use acceptable, highly effective double contraception during study and follow-up period
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Person who can provide written informed consent prior to the commencement of all study procedures
Exclusion Criteria:
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Underlying physical or psychological medical condition to comply with the protocol or complete the study per protocol
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Genetic disorder with severe and abnormal bilirubin metabolism
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Blood or plasma donation or significant blood loss prior to the first administration of IP
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Viral or bacterial infection prior to the first administration of IP
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Poor venous access
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Significant scarring or tattoos at the planned site of IP administration
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History of severe allergic or anaphylactic reactions, or sensitivity to the IP or its constituents
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History or active cardiovascular, respiratory, kidney, endocrine, blood, digestive, central nervous, urinary and/or musculoskeletal disease
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History of malignancy prior to Screening
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Abnormal ECG findings
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History or presence of a condition associated with significant immunosuppression
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History of life-threatening infection
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Infections requiring parenteral antibiotics
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Vaccination prior to the first administration of IP
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Exposure to any significantly immune suppressing drug
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Abnormal vital signs findings
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Abnormal laboratory findings
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Positive results for viral testing at Screening
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Positive result at Screening and Day -1 for toxicology screening panel
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History of substance abuse or dependency or history of recreational intravenous (IV) drug use
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Excess of regular alcohol consumption
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Use of any IP or investigational medical device within 30 days prior to Screening
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Unable to adhere to the prohibited therapies
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Unwilling to adhere to the dietary restrictions
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Unwilling to refrain from strenuous exercise
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CMAX Clinical Research | Adelaide | South Australia | Australia | 5000 |
Sponsors and Collaborators
- Bilix Co.,Ltd.
Investigators
- Study Director: ChoonMo Kang, Director of Clinical development
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BX-001N-001