A Study to Evaluate Adverse Events and How the Drug Moves Through the Body From Subcutaneous (SC) and Intravenous (IV) Doses of ABBV-382 in Healthy Adult Chinese Volunteers

NCT ID: NCT06632938

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-08
• Study Completion Date: 2025-05-15

Brief Summary

The main objectives of this study are to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single subcutaneous (SC) and intravenous (IV) doses of ABBV-382 in healthy adult Chinese volunteers.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ABBV-382 Dose A

Participant will receive a single dose of ABBV-382 Dose A on Day 1 and will be confined to the study site and supervised for approximately 9 days. Participants will be followed-up for approximately 20 weeks.

Group Type: EXPERIMENTAL

ABBV-382

Intervention Type: DRUG

Subcutaneous (SC) Injection

ABBV-382 Dose A Placebo

Participant will receive a single dose of ABBV-382 Dose A placebo on Day 1 and will be confined to the study site and supervised for approximately 9 days. Participants will be followed-up for approximately 20 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo for ABBV-382

Intervention Type: DRUG

SC Injection

ABBV-382 Dose B

Participant will receive a single dose of ABBV-382 Dose B on Day 1 and will be confined to the study site and supervised for approximately 5 days. Participants will be followed-up for approximately 20 weeks.

Group Type: EXPERIMENTAL

ABBV-382

Intervention Type: DRUG

Intravenous (IV) Infusion

ABBV-382 Dose B Placebo

Participant will receive a single dose of ABBV-382 Dose B placebo on Day 1 and will be confined to the study site and supervised for approximately 5 days. Participants will be followed-up for approximately 20 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo for ABBV-382

Intervention Type: DRUG

IV Infusion

Interventions

ABBV-382

Subcutaneous (SC) Injection

Intervention Type: DRUG

ABBV-382

Intravenous (IV) Infusion

Intervention Type: DRUG

Placebo for ABBV-382

IV Infusion

Intervention Type: DRUG

Placebo for ABBV-382

SC Injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body Mass Index (BMI) is >= 18.0 to <= 27.9 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
• Females, Non-Childbearing Potential:

• Premenopausal female with permanent sterility or infertility due to one of following:

• Permanently sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
• Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis OR
• Postmenopausal, defined as age <= 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level >= 30 IU/L.
• Females of Childbearing Potential:

• If a female does not meet the definition of a female of nonchildbearing potential above, she would be considered a female of childbearing potential.
• Females of childbearing potential must not be pregnant or breastfeeding.
• Females of childbearing potential consent to abide by contraception requirements.
• Females of childbearing potential must agree to avoid pregnancy while taking study drug(s) from Study Day 1 through the end of the study (Day 140) plus an additional 90 days.
• Females of childbearing potential must use a contraceptive method that is highly effective (with a failure rate of < 1% per year, when used consistently and correctly).
• Male subjects who are sexually active with a female partner of childbearing potential must agree to use condoms, from Study Day 1 through the end of study (Day 140) plus an additional 90 days, even if the male subject has undergone a successful vasectomy.
• Male subjects who are not considering fathering a child or donating sperm during the study from Study Day 1 through the end of the study (Day 140) plus an additional 90 days.
• Laboratory values meeting those specified in the protocol.
• A condition of generally good health based on the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
• In the opinion of the investigator, this participant is a suitable candidate for enrollment in the study.

Exclusion Criteria

• 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.
• History of any clinically significant sensitivity or allergy to any medication or food, including no history of allergic reaction or anaphylaxis to therapeutic proteins, vaccines, or other parenteral treatments.
• History of hereditary fructose intolerance
• 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.
• 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.
• Donated blood (including plasmapheresis), lost >= 550 mL blood volume, or received a transfusion of any blood product within 3 months prior to study drug administration.
• Has been previously enrolled in this study.
• Participant has been treated with any investigational drug within 3 months or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
• Participant has been treated with any anti-α4β7 integrin monoclonal antibody (Ab) or had prior exposure to ABBV-382.
• Participant has received any live vaccine within 4 weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 4 months (120 days) after the last dose of study drug.
• Participant requires any over-the-counter and/or prescription medication, vitamins and/or herbal supplements, with the exception of contraceptives or hormonal replacement therapies for females, on a regular basis.
• Participant uses any medications, vitamins and/or herbal supplements, with the exception of contraceptives or hormonal replacement therapies for females, within the 2-week period prior to study drug administration.
• Receipt of any drug by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration, with the exception of parenteral hormonal contraceptives or hormonal replacement therapies for females
• Exposure to antibody-based immunotherapy or previous enrollment in antibody-based immunotherapy clinical trials within a period defined by 5 half-lives prior to the first dose of study drug.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Shanghai Xuhui Central Hospital /ID# 264785

Shanghai, Shanghai Municipality, China

Countries

China

Related Links

https://www.abbvieclinicaltrials.com/study/?id=M25-081

Related Info

Other Identifiers

M25-081

Identifier Type: -

Identifier Source: org_study_id