First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of EDI048 in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: EDI048
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: EDI048 or Placebo<br>Part A is a single ascending dose study | Drug: EDI048<br>* Oral Liquid<br>Other: Placebo<br>* Oral Liquid<br>|
| Experimental: Part B: EDI048 or Placebo<br>Part B is a multiple ascending dose study | Drug: EDI048<br>* Oral Liquid<br>Other: Placebo<br>* Oral Liquid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events (AEs) | Number of participants with AEs and Serious Adverse Events (AEs), including significant changes from baseline in vital signs, electrocardiograms and laboratory assessments qualifying and reported as AEs. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parts A and B: Cmax | Characterize the Cmax profile following EDI048 dosing | up to 13 days | 
| Parts A and B: Tmax | Characterize the Tmax profile following EDI048 dosing | up to 13 days | 
| Parts A and B: AUClast | Characterize the AUClast profile following EDI048 dosing | up to 13 days | 
| Parts A and B: AUCinf | Characterize the AUCinf profile following EDI048 dosing | up to 13 days | 
| Parts A and B: T1/2 | Characterize the T1/2 profile following EDI048 dosing | up to 13 days | 
| Part B: AUC0-12h | Characterize the AUC0-12h profile following EDI048 dosing | up to 13 days | 
| Part B: Accumulation (Racc) | Characterize the Racc profile following EDI048 dosing | up to 13 days | 
| Part A: Renal Clearance (CLr) | Characterize the CLr profile following EDI048 dosing | up to 13 days | 
| Part A: Ae0-t | Assess amount of EDI048 excreted in urine | up to 3 day |