Clinical trial NCT06097702: A Study to Evaluate the Safety and Pharmacokinetics of BX-001N in Healthy Participants
Official title: 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 Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ischemia-reperfusion Injury
Lead sponsor: Bilix Co.,Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-24
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Number of participants with Treatment emergent Adverse events (TEAEs)
timeFrame: SAD-Screening to Day 7; MAD- Screening to Day 14
measure: Number of participants with clinical laboratory abnormalities
timeFrame: SAD-Screening to Day 7; MAD- Screening to Day 14
measure: Number of participants with changes in the 12-lead electrocardiogram (ECG)
timeFrame: SAD-Screening to Day 7; MAD- Screening to Day 14
measure: Number of incidences of injection site reactions
timeFrame: SAD-Day 1 to Day 2; MAD- Day 1 to Day 5
Secondary outcomes:
measure: Changes in Cmax (maximum Concentration) of BX-001N with 5 different doses of SAD and 3 different doses of MAD
timeFrame: SAD- Day 1 to Day 7; MAD- Day 1 to Day 14
measure: Changes in Tmax (Time of maximum Concentration) of BX-001N with 5 different doses of SAD and 3 different doses of MAD
timeFrame: SAD- Day 1 to Day 7; MAD- Day 1 to Day 14
measure: Changes in AUC (area under curve) of BX-001N with 5 different doses of SAD and 3 different doses of MAD
timeFrame: SAD- Day 1 to Day 7; MAD- Day 1 to Day 14
measure: Change in Immunogenicity- Incidence of Anti-drug antibody (ADA) by polyethylene glycol (PEG)
timeFrame: SAD-Day 1 to Day 7; MAD- Day 1 to Day 14
measure: Change in Immunogenicity- Titers of Anti-drug antibody (ADA) by polyethylene glycol (PEG)
timeFrame: SAD-Day 1 to Day 7; MAD- Day 1 to Day 14
measure: Change in Immunogenicity- Duration of Anti-drug antibody (ADA) by polyethylene glycol (PEG)
timeFrame: SAD-Day 1 to Day 7; MAD- Day 1 to Day 14
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX Clinical Research
state: South Australia
Study officials:
affiliation: CMAX Clinical Research
name: Angela C Rowland, Dr
role: PRINCIPAL_INVESTIGATOR
References: