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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: EDI048; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham
    • Mere Way, Nottingham, United Kingdom, NG11 6JS
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: EDI048 or Placebo; Part A is a single ascending dose study	Drug: EDI048; Oral Liquid; Other: Placebo; Oral Liquid
Experimental: Part B: EDI048 or Placebo; Part B is a multiple ascending dose study	Drug: EDI048; Oral Liquid; Other: Placebo; Oral Liquid

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2022
• Primary Completion (Actual): December 18, 2024
• Study Completion (Actual): December 18, 2024

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CEDI048A02101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No