Clinical trial NCT05275855: First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of EDI048 in Healthy Volunteers
Official title: A First-in-human, Randomized, Participant and Investigator Blinded, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of EDI048 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-03-11
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of EDI048 administered orally in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female participants 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
* Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18.0 - 30.0 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
* At screening and baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the supine position after the participant has rested for at least three (3) minutes, and again in the standing position. Supine vital signs should be within the following ranges:
* oral body temperature between 35.0-37.5 °C
* systolic blood pressure, 90-139 mmHg
* diastolic blood pressure, 50-89 mmHg
* pulse rate, 40-90 bpm

Exclusion Criteria:

* Participants who have received any IMP in a clinical research study within 90 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations.
* History of multiple and recurring allergies or allergy or hypersensitivity to any of the study treatments, excipients or drugs of similar chemical classes. Hay fever is allowed unless it is active at time of screening or if there is a risk that it may become active during the study.
* Pregnant or nursing (lactating) women, assessed at screening and baseline.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
* Sexually active males unwilling to use a condom during intercourse while taking investigational drug and for 7 days after stopping the investigational drug.

Additional protocol-defined inclusion / exclusion criteria may apply.

Primary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: From the start of treatment to 30 days after end of treatment, assessed up to maximum duration of 8.5 weeks for Part A and 9 weeks for Part B
Secondary outcomes:
measure: Parts A and B: Cmax
timeFrame: up to 13 days
measure: Parts A and B: Tmax
timeFrame: up to 13 days
measure: Parts A and B: AUClast
timeFrame: up to 13 days
measure: Parts A and B: AUCinf
timeFrame: up to 13 days
measure: Parts A and B: T1/2
timeFrame: up to 13 days
measure: Part B: AUC0-12h
timeFrame: up to 13 days
measure: Part B: Accumulation (Racc)
timeFrame: up to 13 days
measure: Part A: Renal Clearance (CLr)
timeFrame: up to 13 days
measure: Part A: Ae0-t
timeFrame: up to 3 day
Other outcomes:
Locations:
city: Mere Way
country: United Kingdom
facility: Novartis Investigative Site
state: Nottingham
Study officials:
References: