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A Study to Evaluate the Safety and Pharmacokinetics of BX-001N in Healthy Participants
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.
Study details:
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 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-11-17
Primary completion: 2024-09-30
Study completion finish: 2024-12-31
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06097702
Intervention or treatment
DRUG: BX-001N Part 1
DRUG: BX-001N Part 2
DRUG: Placebo
Conditions
- • Ischemia-reperfusion Injury
Find a site
Closest Location:
CMAX Clinical Research
Research sites nearby
Select from list below to view details:
CMAX Clinical Research
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: BX-001N Part 1
| DRUG: BX-001N Part 1
|
EXPERIMENTAL: BX-001N Part 2
| DRUG: BX-001N Part 2
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Number of participants with Treatment emergent Adverse events (TEAEs) | TEAE will be collected to assess participants' safety after BX-001N treatment | SAD-Screening to Day 7; MAD- Screening to Day 14 |
Number of participants with clinical laboratory abnormalities | Not Specified | SAD-Screening to Day 7; MAD- Screening to Day 14 |
Number of participants with changes in the 12-lead electrocardiogram (ECG) | Not Specified | SAD-Screening to Day 7; MAD- Screening to Day 14 |
Number of incidences of injection site reactions | Not Specified | SAD-Day 1 to Day 2; MAD- Day 1 to Day 8 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
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 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. | SAD- Day 1 to Day 3; MAD- Day 1 to Day 8 |
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 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 | SAD- Day 1 to Day 3; MAD- Day 1 to Day 8 |
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 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. | SAD- Day 1 to Day 3; MAD- Day 1 to Day 8 |
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 | 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 | 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 | SAD-Day 1 to Day 7; MAD- Day 1 to Day 14 |
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