A Study to Assess the Safety and Effects of the Investigational Drug BW-40202 in Healthy Volunteers

Official title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-40202 in Healthy Subjects

Overview

This study will test the safety of a new drug called BW-40202 in healthy adults. The drug is a clear liquid given as an injection under the skin (subcutaneous injection). The study will test five different doses of BW-40202 compared to a placebo (saltwater solution). Participants will be divided into five groups, with each group receiving a different dose of BW-40202 or placebo. In each group, eight people will be randomly assigned to receive either the drug (6 people) or placebo (2 people). The Safety Review Committee will review the safety data before increasing the dose for the next group. Study nurses or trained staff will give the injections. Pharmacy staff will keep records of how much drug each participant receives, any returned or destroyed doses, and any changes from the planned dosing schedule. These records will be securely stored and available for review.

Interventions

• Drug BW-40202 injection
  BW-40202 is a conjugate drug, dosage form is solution for injection and route of administration is subcutaneous injection
• Other Sodium Chloride
  Placebo (sodium chloride injection) will be administered as Subcutaneous injection

Primary outcome measures

• Proportion of participants experiencing at least one treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from baseline to Day 169. To determine the incidenc of TEAEs and SAEs. [Time frame: From first participant enrolled until Day 169 post-dose of last participant]
• Collecting the adverse events(AEs) up to D169 and the AEs will be categorized based on Medical Dictionary for Regulatory Activities (MedDRA) terms and clssified by System Organ Class (SOC) and Preferred Term (PT) for summary. [Time frame: From first participant enrolled until Day 169 post-dose of last participant]
• Grading the TEAE and SAE based on severity and number of TEAEs and SAEs will be listed based on severity from baseline to Day 169. [Time frame: From first participant enrolled until Day 169 post-dose of last participant]
• Hematology results (concentration of Hemoglobin, g/L; Platelets, 10^9/L; Red blood cell count, 10^12/L) at each time point, including changes from baseline to Day 169 post dose will be summarized by treatment group. [Time frame: From first participant enrolled until Day 169 post-dose of last participant]
• Coagulation results (Activated partial thermoplastic time, s; Prothrombin time, s) at each time point, including changes from baseline to Day 169 post dose will be summarized by treatment group. [Time frame: From first participant enrolled until Day 169 post-dose of last participant]
• Chemistry results (concentration of Albumin, g/L; Alkaline Phosphatase, U/L; Alanine Amintransferase, U/L; Aspartate Aminotransferase, U/L;Direct Billirubin umol/L) at each time point from baseline to Day 169 will be summarized by treatment group. [Time frame: From first participant enrolled until Day 169 post-dose of last participant]
• Urinalysis results（Epithelial cells, crystals, casts, bilirubin) at each time point, including change from baseline to Day 169 post dose will be summarized in the table by treatment group. [Time frame: From first participant enrolled until Day 169 post-dose of last participant]
• Vital signs (blood pressures, millimeters of mercury) changes from Baseline values to Day 169 post dose will be summarized in the table by treatment group. [Time frame: From first participant enrolled until Day 169 post-dose of last participant]
• Vital signs (heart rate, beats per minute) changes from Baseline values to Day 169 post dose will be summarized in the table by treatment group. [Time frame: From first participant enrolled until Day 169 post-dose of last participant]
• Vital signs (temperature,degrees Celsius) changes from Baseline values to Day 169 post dose will be summarized in the table by treatment group. [Time frame: From first participant enrolled until Day 169 post-dose of last participant]

Secondary outcome measures (6)

• maximum plasma concentration data (Cmax, ng/mL) of BW-40202 will be collected for all cohorts at the scheduled PK sampling timepoints. [Time frame: From first patient enrolled until Day 8 post-dose of last patient.]
• Time to Maximum plasma concentration (Tmax, hr) of BW-40202 will be calculated (hr). T max(Time to Maximum Concentration) is the time at which the maximum observed plasma drug concentration ( Cmax) occurs after drug administration. [Time frame: From first patient enrolled until Day 8 post-dose of last patient.]
• Calculate the Area Under the Plasma Concentration-Time Curve (AUC, hr*ng/mL), to estimate the AUC beyond the last observed time point (AUC0-∞), the AUC from 0 to 24 hours and AUC from 0 to 48 hours. The AUC represents the total drug exposure over time. [Time frame: From first patient enrolled until Day 8 post-dose of last patient.]
• Calculate the time required for the plama concentration of a drug to decrease by 50% in the elimination phase. Which is called terminal elimination half-life (t1/2, hr) [Time frame: From first patient enrolled until Day 8 post-dose of last patient]
• Calculate the Urine output (Aet, mg), Aet (total amount of drug excreted in urine during each time interval) [Time frame: From first participant being enrolled until 24 hours post-dose of last enrolled participant]
• Calculate the Urine output (Clr, L/h), the renal clearance measures the efficiency of drug elimination by the kidneys. [Time frame: From first participant being enrolled until 24 hours post-dose of last enrolled participant]

Eligibility criteria

Inclusion criteria

• Must have given written informed consent and be able to comply with all study requirements.
• Males or females aged 18 to 60 years old, inclusive, at the time of informed consent.
• BMI ≥18 and ≤32 kg/m2 with 50 kg <body weight ≤100 kg.

Exclusion criteria

• Any clinically significant chronic medical condition or clinically significant abnormality in laboratory parameters that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.
• Hospitalization for any reason within 60 days prior to screening.
• Any clinically significant acute condition such as fever (>38 degree centigrade) or acute respiratory illness within 14 days of study drug administration.
• Systolic blood pressure (more than equal to) 140 mmHg and/or diastolic blood pressure (more than equal to) 90 mmHg after at least 5 minutes resting (seated or supine) at screening and Day -1(Repeat blood pressure measurement will be allowed at the discretion of the investigator).
• Any liver function panel analyte value > 1.2 × upper limits of normal (ULN) which includes aspartate transaminase (AST), alanine transaminase (ALT), total bilirubin (TBIL), alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) at screening.
• International normalized ratio (INR) above 1.2 × ULN at screening or Day -1.
• Single 12-lead electrocardiogram (ECG) with clinically significant abnormalities at screening or Day -1, asdetermined by the clinical investigator.
• History or clinical evidence of alcohol abuse,
• History or clinical evidence of drug abuse, within the 12 months before screening.
• Donated or lost >200 mL of blood within 30 days prior to screening.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Sequential

Masking

Triple blind

Primary purpose

Treatment

Study locations

Australia · 2 centers

• Q-Pharm Pty Ltd. — Brisbane
• Nucleus Network Pty Ltd — Melbourne

Identifiers

NCT: NCT06917482 · BW-40202-1001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗