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CompletedNCT05275855Updated Jan 10, 2025

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

A Phase 1 interventional study of EDI048 and Placebo in Healthy Volunteers, sponsored by Novartis Pharmaceuticals. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-10.

Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Part A: EDI048 or Placebo

    Part A is a single ascending dose study

    Drug: EDI048 · Other: Placebo

  • Experimental
    Part B: EDI048 or Placebo

    Part B is a multiple ascending dose study

    Drug: EDI048 · Other: Placebo

Interventions

  • DrugEDI048

    Oral Liquid

  • OtherPlacebo

    Oral Liquid

06

What researchers measure

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.

    Time frame: 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

  1. Parts A and B: Cmax

    Characterize the Cmax profile following EDI048 dosing

    Time frame: up to 13 days

  2. Parts A and B: Tmax

    Characterize the Tmax profile following EDI048 dosing

    Time frame: up to 13 days

  3. Parts A and B: AUClast

    Characterize the AUClast profile following EDI048 dosing

    Time frame: up to 13 days

  4. Parts A and B: AUCinf

    Characterize the AUCinf profile following EDI048 dosing

    Time frame: up to 13 days

  5. Parts A and B: T1/2

    Characterize the T1/2 profile following EDI048 dosing

    Time frame: up to 13 days

  6. Part B: AUC0-12h

    Characterize the AUC0-12h profile following EDI048 dosing

    Time frame: up to 13 days

  7. Part B: Accumulation (Racc)

    Characterize the Racc profile following EDI048 dosing

    Time frame: up to 13 days

  8. Part A: Renal Clearance (CLr)

    Characterize the CLr profile following EDI048 dosing

    Time frame: up to 13 days

  9. Part A: Ae0-t

    Assess amount of EDI048 excreted in urine

    Time frame: up to 3 day

07

Study locations

1 site
  • Novartis Investigative Site
    Mere Way, Nottingham NG11 6JS, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05275855
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Mar 11, 2022
Start date
Apr 29, 2022
Primary completion
Dec 18, 2024
Completion
Dec 18, 2024
Last update
Jan 10, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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