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

Novartis

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: EDI048; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05275855

CEDI048A02101

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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110 participants in 2 patient groups

Part A: EDI048 or Placebo

Experimental group

Description:

Part A is a single ascending dose study

Treatment:

Other: Placebo

Drug: EDI048

Part B: EDI048 or Placebo

Experimental group

Description:

Part B is a multiple ascending dose study

Treatment:

Other: Placebo

Drug: EDI048