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

PHASE1RECRUITING

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.

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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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

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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

Image related to Ischemia-reperfusion Injury

Condition: Ischemia-reperfusion Injury
DRUG: BX-001N Part 1 and other drugs
Adelaide, South Australia, Australia
Sponsor: Bilix Co.,Ltd.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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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 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 and followed up for 14 days.
PLACEBO_COMPARATOR: Placebo Matching doses of placebo	DRUG: Placebo Participants will receive matching placebo across Part 1 and 2 of the study.

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

Frequently Asked Questions

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References

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