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

NCT05275855 | Completed Phase 1

• 1 other identifier: CEDI048A02101
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Parts A and B: Cmax

  up to 13 days

• Parts A and B: Tmax

  up to 13 days

• Parts A and B: AUClast

  up to 13 days

• Parts A and B: AUCinf

  up to 13 days

• Parts A and B: T1/2

  up to 13 days

Study Arms (2)

Part A: EDI048 or Placebo

EXPERIMENTAL

Part A is a single ascending dose study

Drug: EDI048; Other: Placebo

Part B: EDI048 or Placebo

EXPERIMENTAL

Part B is a multiple ascending dose study

Drug: EDI048; Other: Placebo

Interventions

EDI048 DRUG

Oral Liquid

Part A: EDI048 or Placebo; Part B: EDI048 or Placebo

Placebo OTHER

Oral Liquid

Part A: EDI048 or Placebo; Part B: EDI048 or Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Mere Way, Nottingham, NG11 6JS, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: April 29, 2022
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)