A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Emraclidine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07219030

M25-904

Details and patient eligibility

About

This study is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, and tolerability.

Enrollment: 32 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
• Body weight > 45 kg at the time of screening and upon initial confinement.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion criteria

• History of any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, genitourinary, immunological, hematologic, neurological or psychiatric disease or disorder, or any other uncontrolled medical illness.
• History of any clinically significant sensitivity or allergy to any medication or food.
• Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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32 participants in 4 patient groups

Emraclidine or Placebo- Group 1

Experimental group

Description:

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days

Treatment:

Drug: Placebo

Drug: Emraclidine

Emraclidine or Placebo- Group 2

Experimental group

Description:

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days

Treatment:

Drug: Placebo

Drug: Emraclidine

Emraclidine or Placebo- Group 3

Experimental group

Description:

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.

Treatment:

Drug: Placebo

Drug: Emraclidine

Emraclidine or Placebo- Group 4

Experimental group

Description:

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.

Treatment:

Drug: Placebo

Drug: Emraclidine