A Single and Multiple Dose Escalation First-In-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Delcetravir Administered Via Inhalation in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Esfam Biotech Pty Ltd
- Enrollment
- 8
- Primary Endpoint
- Laboratory measurement of creatinine concentration after active comparator and placebo.
- Last Updated
- 3 years ago
Overview
Brief Summary
This study will be a single center, Phase I, randomized, double-blind, placebo controlled, single and multiple ascending dose (SAD/MAD) study evaluating the safety, tolerability, and PK of Delcetravir after administration via oral inhalation in healthy subjects.
Detailed Description
Primary objectives: * To evaluate the safety and tolerability of single and multiple doses of Delcetravir in healthy subjects (18-50 years of age). * To evaluate the safety and tolerability of single and multiple doses of Delcetravir in healthy subjects (50-80 years of age). * To evaluate the pharmacokinetics (PK) of Delcetravir after single and multiple doses of ESFAM289 in healthy subjects (18-50 years of age). * To evaluate the PK of Delcetravir after single and multiple doses of Delcetravir in healthy subjects (50-80 years of age) Secondary objectives: * To compare the PK of Delcetravir after single and multiple doses of Delcetravir in age stratified subjects (18-50 vs. 50-80 years of age). * To compare the safety and tolerability after single and multiple doses of Delcetravir in age stratified subjects (18-50 vs. 50-80 years of age).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the following criteria to be included in the study:
- •Male or female, non-smokers or casual smokers (defined as smoking the equivalent of less than an average of 5 cigarettes per week, and willing to abstain from smoking during involvement in the study), ≥18 and \<50 (For Parts A and B) or ≥50 and ≤80 (for Parts C and D) years of age, with BMI \>18.0 and \<32.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
- •Healthy as defined by:
- •the absence of clinically significant illness and surgery within 4 weeks prior to dosing.
- •the absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- •Females of childbearing potential who are sexually active with a male partner must be willing to use one of the following acceptable contraceptive methods throughout the study and for 30 days after the last study drug administration:
- •Simultaneous use of intra-uterine device placed at least 4 weeks prior to study drug administration, and condom for the male partner;
- •Simultaneous use of hormonal contraceptives started at least 4 weeks prior to study drug administration and condom for the male partner.
- •Sterile male partner (vasectomized since at least 6 months).
- •Females of non-childbearing potential must be:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Laboratory measurement of creatinine concentration after active comparator and placebo.
Time Frame: 22 days
Serum creatinine in umol/L
Laboratory measurement of ALT concentration after active comparator and placebo.
Time Frame: 22 days
Serum ALT in U/L
Laboratory measurement of AST concentration after active comparator and placebo.
Time Frame: 22 days
Serum AST in U/L
Laboratory measurement of alkaline phosphatase concentration after active comparator and placebo.
Time Frame: 22 days
Serum alkaline phosphatase in U/L
Heart rate after active comparator and placebo.
Time Frame: 22 days
Heart rate in beats per minute
Number of subjects with chest pain after single and multiple ascending doses of active and placebo comparator
Time Frame: 22 days
Symptoms of chest pain
Number of subjects with shortness of breath after single and multiple ascending doses of active and placebo comparator
Time Frame: 22 days
Symptoms of shortness of breath
Number of subjects with cough after single and multiple ascending doses of active and placebo comparator
Time Frame: 22 days
Symptoms of cough
Number of subjects with sputum production after single and multiple ascending doses of active and placebo comparator
Time Frame: 22 days
Symptoms of sputum production
Hemoglobin assessment after active comparator and placebo.
Time Frame: 22 days
Hemoglobin in g/L
White cell count assessment after active comparator and placebo.
Time Frame: 22 days
White cell count differential in 109/L
Platelet count assessment after active comparator and placebo.
Time Frame: 22 days
Platelet count in 109/L
Laboratory meaurement of sodium concentration after active comparator and placebo.
Time Frame: 22 days
Serum sodium in mmol/L
Laboratory measurement of potassium concentration after active comparator and placebo.
Time Frame: 22 days
Serum potassium in mmol/L
Laboratory measurement of bicarbonate concentration after active comparator and placebo.
Time Frame: 22 days
Serum bicarbonate in mmol/L
Blood pressure after active comparator and placebo.
Time Frame: 22 days
Systolic and diastolic blood pressure in mmHg
Laboratory measurement of urea concentration after active comparator and placebo.
Time Frame: 22 days
Serum urea in mmol/L
Respiratory rate after active comparator and placebo.
Time Frame: 22 days
Respiratory rate in breaths per minute
Pulse oximetry measurement after active comparator and placebo.
Time Frame: 22 days
Pulse oximetry in blood oxygen saturation
ECG after active comparator and placebo.
Time Frame: 22 days
PR interval, QRS complex, QTc interval