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
This study comprises of 2 parts: * 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 4 sequential daily. At the same time each morning from Day 1 to Day 4 (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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
51
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.
Dosage form- IV bolus Dosage- In the three cohorts, each participant receives a single IV bolus administration for 4 sequential days in one of the three doses based on body weight and followed up for 14 days.
Participants will receive matching placebo across Part 1 and 2 of the study.
CMAX Clinical Research
Adelaide, South Australia, Australia
Number of participants with Treatment emergent Adverse events (TEAEs)
TEAE will be collected to assess participants' safety after BX-001N treatment
Time frame: SAD-Screening to Day 7; MAD- Screening to Day 14
Number of participants with clinical laboratory abnormalities
Time frame: SAD-Screening to Day 7; MAD- Screening to Day 14
Number of participants with changes in the 12-lead electrocardiogram (ECG)
Time frame: SAD-Screening to Day 7; MAD- Screening to Day 14
Number of incidences of injection site reactions
Time frame: SAD-Day 1 to Day 2; MAD- Day 1 to Day 5
Changes in Cmax (maximum Concentration) of BX-001N with 5 different doses of SAD and 3 different doses of MAD
SAD's samples of PK are collected at total 14 time points up to Day 7 post dose. MAD's samples of PK are collected at total 26 time points from pre-dose and up to day 14 after dosing.
Time frame: SAD- Day 1 to Day 7; MAD- Day 1 to Day 14
Changes in Tmax (Time of maximum Concentration) of BX-001N with 5 different doses of SAD and 3 different doses of MAD
SAD's samples of PK are collected at total 14 time points up to Day 7 post dose. MAD's samples of PK are collected at total 26 time points from pre-dose and up to day 14 after dosing.
Time frame: SAD- Day 1 to Day 7; MAD- Day 1 to Day 14
Changes in AUC (area under curve) of BX-001N with 5 different doses of SAD and 3 different doses of MAD
SAD's samples of PK are collected at total 14 time points up to Day 7 post dose. MAD's samples of PK are collected at total 26 time points from pre-dose and up to Day 14 after dosing.
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Time frame: SAD- Day 1 to Day 7; MAD- Day 1 to Day 14
Change in Immunogenicity- Incidence of Anti-drug antibody (ADA) by polyethylene glycol (PEG)
Up to 3 samples will be collected in total and additional samples if positive results
Time frame: SAD-Day 1 to Day 7; MAD- Day 1 to Day 14
Change in Immunogenicity- Titers of Anti-drug antibody (ADA) by polyethylene glycol (PEG)
Up to 3 samples will be collected in total and additional samples if positive results
Time frame: SAD-Day 1 to Day 7; MAD- Day 1 to Day 14
Change in Immunogenicity- Duration of Anti-drug antibody (ADA) by polyethylene glycol (PEG)
Up to 3 samples will be collected in total and additional samples if positive results
Time frame: SAD-Day 1 to Day 7; MAD- Day 1 to Day 14