Recruiting
Phase 1

Emraclidine

Sponsor:

AbbVie

Code:

NCT07219030

Conditions

Healthy Volunteer

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

Emraclidine

Placebo

Study Details

Brief summary:

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

Conditions

Healthy Volunteer

Study ID

NCT07219030

Start date

Oct 8, 2025

Status verified date

May, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Emraclidine or Placebo- Group 1

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

experimental: Emraclidine or Placebo- Group 2

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

experimental: Emraclidine or Placebo- Group 3

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

experimental: Emraclidine or Placebo- Group 4

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

experimental: Emraclidine or Placebo- Group 5

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

Interventions

Emraclidine

Oral tablets

Placebo

Oral tablets

Primary outcome measure

  • Number of Participants Experiencing Adverse Events [ Time Frame: Up to approximately 50 days ]
  • Number of Participants with Clinical Significant Change From Baseline in Vital Sign Measurements [ Time Frame: Up to approximately 20 days ]
  • Number of Participants with Clinical Significant Change from Baseline in Electrocardiogram (ECG) [ Time Frame: Up to approximately 20 days ]
  • Number of Participants with Clinical Significant Change in Physical Examinations [ Time Frame: Up to approximately 20 days ]
  • Number of Participants with Clinical Significant Change in Clinical Laboratory Test Results Like Hematology will be Assessed [ Time Frame: Up to approximately 20 days ]
  • Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to approximately 20 days ]
  • Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Up to approximately 20 days ]
  • Change From Baseline in Barnes Akathisia Rating Scale (BARS) [ Time Frame: Up to approximately 20 days ]
  • Change From Baseline in Simpson-Angus Scale (SAS) [ Time Frame: Up to approximately 20 days ]
  • Maximum Observed Plasma Concentration (Cmax) of Emraclidine [ Time Frame: Up to approximately 20 days ]
  • Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364) [ Time Frame: Up to approximately 20 days ]
  • Time to Cmax (Tmax) of Emraclidine [ Time Frame: Up to approximately 20 days ]
  • Time to Cmax (Tmax) of Metabolite (CV-0000364) [ Time Frame: Up to approximately 20 days ]
  • Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine [ Time Frame: Up to approximately 20 days ]
  • Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036) [ Time Frame: Up to approximately 20 days ]
  • Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine [ Time Frame: Up to approximately 20 days ]
  • Minimum plasma concentration (Cmin) of Emraclidine [ Time Frame: Up to approximately 20 days ]
  • Minimum plasma concentration (Cmin) of Metabolite (CV-0000364) [ Time Frame: Up to approximately 20 days ]
  • Average plasma concentration (Cavg) of Emraclidine [ Time Frame: Up to approximately 20 days ]
  • Average plasma concentration (Cavg) of Metabolite (CV-0000364) [ Time Frame: Up to approximately 20 days ]
  • Metabolite to Parent Ratio (MRCmax) of Emraclidine [ Time Frame: Up to approximately 20 days ]
  • Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364) [ Time Frame: Up to approximately 20 days ]
  • Metabolite to Parent Ratio (MRAUCtau) of Emraclidine [ Time Frame: Up to approximately 20 days ]
  • Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-000036) [ Time Frame: Up to approximately 20 days ]
  • Terminal Phase Elimination Half-Life (t1/2) of Emraclidine [ Time Frame: Up to approximately 20 days ]
  • Terminal Phase Elimination Half-Life (t1/2) of Metabolite (CV-000036) [ Time Frame: Up to approximately 20 days ]
  • Apparent terminal phase elimination constant (β) of Emraclidine [ Time Frame: Up to approximately 20 days ]
  • Apparent terminal phase elimination constant (β) of Metabolite (CV-0000364) [ Time Frame: Up to approximately 20 days ]
  • Peak-to-trough ratio (PTR) of Emraclidine [ Time Frame: Up to approximately 20 days ]
  • Peak-to-trough ratio (PTR) of Metabolite (CV-000036) [ Time Frame: Up to approximately 20 days ]
  • Accumulation ratio for Cmax (RacCmax) of Emraclidine [ Time Frame: Up to approximately 20 days ]
  • Accumulation ratio for Cmax (RacCmax) of Metabolite (CV-0000364) [ Time Frame: Up to approximately 20 days ]
  • Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine [ Time Frame: Up to approximately 20 days ]
  • Accumulation ratio for AUCtau (RacAUCtau) of Metabolite (CV-0000364) [ Time Frame: Up to approximately 20 days ]
  • Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine [ Time Frame: Up to approximately 20 days ]
  • Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine [ Time Frame: Up to approximately 20 days ]
  • Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-0000364) [ Time Frame: Up to approximately 20 days ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Altasciences Clinical Los Angeles /ID# 276854

Recruiting

Cypress, California, United States, 90630

K2 Medical Research, LLC /ID# 276636

Recruiting

Maitland, Florida, United States, 32751

Clinical Pharmacology Of Miami /ID# 276856

Recruiting

Miami, Florida, United States, 33172

Contacts

Site Coordinator

786-493-9466

Acpru /Id# 276996

Recruiting

Grayslake, Illinois, United States, 60030

Contacts

Site Coordinator

847-935-4400

More Information

Sponsor

AbbVie

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

  • Healthy Volunteer
  • ABBV-1231

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-05-12.