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

NCT06632938 | Completed Phase 1

• 1 other identifier: M25-081
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy Volunteer; ABBV-382

Outcome Measures

Primary Outcomes (8)

• Number of Participants with Adverse Events (AEs)

  An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Up to Approximately Day 140

• Maximum Observed Serum Concentration (Cmax) of ABBV-382

  Maximum observed serum concentration (Cmax) of ABBV-382.

  Up to Day 112

• Time to Cmax (Tmax) of ABBV-382

  Time to Cmax (Tmax) of ABBV-382.

  Up to Day 112

• Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-382

  Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-382.

  Up to Day 112

• Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-382

  AUC from time 0 to infinite time (AUCinf) of ABBV-382.

  Up to Day 112

• Terminal Phase Elimination Rate Constant (β) of ABBV-382

  Terminal phase elimination rate constant of ABBV-382.

  Up to Day 112

• Terminal Phase Elimination Half-Life (t1/2) of ABBV-382

  Terminal phase elimination half-life of ABBV-382.

  Up to Day 112

• Anti-Drug Antibody (ADA) of ABBV-382

  Confirmed Positive ADA Results.

  Up to Day 112

Study Arms (4)

ABBV-382 Dose A

EXPERIMENTAL

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.

Drug: ABBV-382

ABBV-382 Dose A Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo for ABBV-382

ABBV-382 Dose B

EXPERIMENTAL

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.

Drug: ABBV-382

ABBV-382 Dose B Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo for ABBV-382

Interventions

ABBV-382 DRUG

Subcutaneous (SC) Injection

ABBV-382 Dose A

Placebo for ABBV-382 DRUG

IV Infusion

ABBV-382 Dose B Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Shanghai Xuhui Central Hospital /ID# 264785

Shanghai, Shanghai Municipality, 200031, China

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 9, 2024
• Study Start: October 8, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)