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

A Phase 1, Randomized, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Emraclidine Following Multiple Ascending Oral Doses in Healthy Elderly Subjects

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Placebo; Drug: Emraclidine

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • Recruiting
      • Altasciences Clinical Los Angeles /ID# 276854
  • Florida
    • Maitland, Florida, United States, 32751
      • Recruiting
      • K2 Medical Research, LLC /ID# 276636
    • Miami, Florida, United States, 33172
      • Recruiting
      • Clinical Pharmacology Of Miami /ID# 276856
      • Contact: Site Coordinator; Phone Number: 786-493-9466
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Recruiting
      • Acpru /Id# 276996
      • Contact: Site Coordinator; Phone Number: 847-935-4400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emraclidine or Placebo- Group 1; Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days	Drug: Placebo; Oral tablets; Drug: Emraclidine; Oral tablets
Experimental: Emraclidine or Placebo- Group 2; Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days	Drug: Placebo; Oral tablets; Drug: Emraclidine; Oral tablets
Experimental: Emraclidine or Placebo- Group 3; Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.	Drug: Placebo; Oral tablets; Drug: Emraclidine; Oral tablets
Experimental: Emraclidine or Placebo- Group 4; Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.	Drug: Placebo; Oral tablets; Drug: Emraclidine; Oral tablets
Experimental: Emraclidine or Placebo- Group 5; Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.	Drug: Placebo; Oral tablets; Drug: Emraclidine; Oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Adverse Events	An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Up to approximately 50 days
Number of Participants with Clinical Significant Change From Baseline in Vital Sign Measurements	Number of participants with clinical significant change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.	Up to approximately 20 days
Number of Participants with Clinical Significant Change from Baseline in Electrocardiogram (ECG)	12-lead resting ECG will be recorded.	Up to approximately 20 days
Number of Participants with Clinical Significant Change in Physical Examinations	Number of participants with clinical significant change in physical examinations will be assessed.	Up to approximately 20 days
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)	The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.	Up to approximately 20 days
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)	AIMS assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. The first 10 items are rated on a none (0) to severe (4) scale. There are an additional 2 items on dental status that are answered yes or no.	Up to approximately 20 days
Change From Baseline in Barnes Akathisia Rating Scale (BARS)	BARS is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia (each on a 4-point scale from normal [0] to severe [3]). In addition, there is a global severity for akathisia rated on a 6-point scale (absent [0] to severe akathisia [5]).	Up to approximately 20 days
Change From Baseline in Simpson-Angus Scale (SAS)	SAS is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Each item ranges from 0 (normal) to 4 (extreme symptoms). The scale consists of 1 item measuring gait (hypokinesia), 6 items measuring rigidity, and 3 items measuring glabella tap, tremor, and salivation, respectively.	Up to approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Emraclidine	Cmax of Emraclidine	Up to approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)	Cmax of Metabolite (CV-0000364)	Up to approximately 20 days
Time to Cmax (Tmax) of Emraclidine	Tmax of Emraclidine	Up to approximately 20 days
Time to Cmax (Tmax) of Metabolite (CV-0000364)	Tmax of Metabolite (CV-000036)	Up to approximately 20 days
Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine	AUCt of Emraclidine	Up to approximately 20 days
Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)	AUCt of Metabolite (CV-000036)	Up to approximately 20 days
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine	AUCtau of Emraclidine	Up to approximately 20 days
Minimum plasma concentration (Cmin) of Emraclidine	Cmin of Emraclidine	Up to approximately 20 days
Minimum plasma concentration (Cmin) of Metabolite (CV-0000364)	Cmin of Metabolite (CV-0000364)	Up to approximately 20 days
Average plasma concentration (Cavg) of Emraclidine	Cavg of Emraclidine	Up to approximately 20 days
Average plasma concentration (Cavg) of Metabolite (CV-0000364)	Cavg of Metabolite (CV-0000364)	Up to approximately 20 days
Metabolite to Parent Ratio (MRCmax) of Emraclidine	MRCmax of Emraclidine calculated from Cmax	Up to approximately 20 days
Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364)	MRCmax of Metabolite (CV-0000364) calculated from Cmax	Up to approximately 20 days
Metabolite to Parent Ratio (MRAUCtau) of Emraclidine	MRAUCtau of Emraclidine based on AUCtau	Up to approximately 20 days
Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-000036)	MRAUCtau of Metabolite (CV-000036) based on AUCtau	Up to approximately 20 days
Terminal Phase Elimination Half-Life (t1/2) of Emraclidine	Terminal phase elimination half-life of Emraclidine	Up to approximately 20 days
Terminal Phase Elimination Half-Life (t1/2) of Metabolite (CV-000036)	Terminal phase elimination half-life of Metabolite (CV-000036)	Up to approximately 20 days
Apparent terminal phase elimination constant (β) of Emraclidine	β of Emraclidine	Up to approximately 20 days
Apparent terminal phase elimination constant (β) of Metabolite (CV-0000364)	β of Metabolite (CV-0000364)	Up to approximately 20 days
Peak-to-trough ratio (PTR) of Emraclidine	PTR of Emraclidine	Up to approximately 20 days
Peak-to-trough ratio (PTR) of Metabolite (CV-000036)	PTR of Metabolite (CV-000036)	Up to approximately 20 days
Accumulation ratio for Cmax (RacCmax) of Emraclidine	RacCmax of Emraclidine	Up to approximately 20 days
Accumulation ratio for Cmax (RacCmax) of Metabolite (CV-0000364)	RacCmax of Metabolite (CV-0000364)	Up to approximately 20 days
Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine	RacAUCtau of Emraclidine	Up to approximately 20 days
Accumulation ratio for AUCtau (RacAUCtau) of Metabolite (CV-0000364)	RacAUCtau of Metabolite (CV-0000364)	Up to approximately 20 days
Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine	CL/F of Emraclidine	Up to approximately 20 days
Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine	Vz/F of Emraclidine	Up to approximately 20 days
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-0000364)	AUCtau of Metabolite (CV-0000364)	Up to approximately 20 days
Number of Participants with Clinical Significant Change in Clinical Laboratory Test Results Like Hematology will be Assessed	Number of participants with clinical significant change in clinical laboratory test results will be assessed.	Up to approximately 20 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: October 17, 2025
• First Submitted That Met QC Criteria: October 17, 2025
• First Posted (Actual): October 21, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteer; ABBV-1231
• Other Study ID Numbers: M25-904

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
• product manufactured in and exported from the U.S.: No