First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of EDI048 in Healthy Volunteers
- Conditions
- Healthy Volunteers
- Registration Number
- NCT05275855
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria:<br><br> - Healthy male and female participants 18 to 55 years of age included, and in good<br> health as determined by past medical history, physical examination, vital signs,<br> electrocardiogram, and laboratory tests at screening.<br><br> - Participants must weigh at least 50 kg to participate in the study, and must have a<br> body mass index (BMI) within the range of 18.0 - 30.0 kg/m2. BMI = Body weight (kg)<br> / [Height (m)]2<br><br> - At screening and baseline, vital signs (systolic and diastolic blood pressure and<br> pulse rate) will be assessed in the supine position after the participant has rested<br> for at least three (3) minutes, and again in the standing position. Supine vital<br> signs should be within the following ranges:<br><br> - oral body temperature between 35.0-37.5 °C<br><br> - systolic blood pressure, 90-139 mmHg<br><br> - diastolic blood pressure, 50-89 mmHg<br><br> - pulse rate, 40-90 bpm<br><br>Exclusion Criteria:<br><br> - Participants who have received any IMP in a clinical research study within 90 days<br> or 5 half-lives of enrollment, whichever is longer; or longer if required by local<br> regulations.<br><br> - History of multiple and recurring allergies or allergy or hypersensitivity to any of<br> the study treatments, excipients or drugs of similar chemical classes. Hay fever is<br> allowed unless it is active at time of screening or if there is a risk that it may<br> become active during the study.<br><br> - Pregnant or nursing (lactating) women, assessed at screening and baseline.<br><br> - Women of child-bearing potential, defined as all women physiologically capable of<br> becoming pregnant.<br><br> - Sexually active males unwilling to use a condom during intercourse while taking<br> investigational drug and for 7 days after stopping the investigational drug.<br><br>Additional protocol-defined inclusion / exclusion criteria may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs)
- Secondary Outcome Measures
Name Time Method Parts A and B: Cmax;Parts A and B: Tmax;Parts A and B: AUClast;Parts A and B: AUCinf;Parts A and B: T1/2;Part B: AUC0-12h;Part B: Accumulation (Racc);Part A: Renal Clearance (CLr);Part A: Ae0-t