A Study to Assess Adverse Events and How Single and Multiple Ascending Doses of ABBV-903 Move Through the Body in Healthy Adults

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: ABBV-903; Drug: Placebo for ABBV-903; Drug: Itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT05691699

M24-112

Details and patient eligibility

About

The purpose of this study is to evaluate adverse events and tolerability of single and multiple doses of ABBV-903, and to assess how the drug moves through the body in healthy adult volunteers.

Enrollment: 104 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) is => 18.0 to <= 32 kg/m2 after rounded to the nearest tenth, at 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 electrocardiogram (ECG).

Exclusion criteria

• History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
• 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: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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104 participants in 6 patient groups

Part 1, ABBV-903

Experimental group

Description:

Participants will receive a single ascending dose of ABBV-903 in Part 1.

Treatment:

Drug: ABBV-903

Part 1, Placebo

Experimental group

Description:

Participants will receive a single ascending dose of placebo in Part 1.

Treatment:

Drug: Placebo for ABBV-903

Part 2, ABBV-903

Experimental group

Description:

Participants will receive multiple ascending doses of ABBV-903 in Part 2.

Treatment:

Drug: ABBV-903

Part 2, Placebo

Experimental group

Description:

Participants will receive multiple ascending doses of placebo in Part 2.

Treatment:

Drug: Placebo for ABBV-903

Part 3, Sequence 1

Experimental group

Description:

Participants in Part 3 will follow Sequence 1.

Treatment:

Drug: ABBV-903

Drug: Itraconazole

Part 3, Sequence 2

Experimental group

Description:

Participants in Part 3 will follow Sequence 2.

Treatment:

Drug: ABBV-903

Drug: Itraconazole