Clinical trial NCT06632938: 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
Official title: A Randomized, Single-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ABBV-382 in Healthy Adult Chinese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
ABBV-382
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-10-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Approximately Day 140
measure: Maximum Observed Serum Concentration (Cmax) of ABBV-382
timeFrame: Up to Day 112
measure: Time to Cmax (Tmax) of ABBV-382
timeFrame: Up to Day 112
measure: Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-382
timeFrame: Up to Day 112
measure: Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-382
timeFrame: Up to Day 112
measure: Terminal Phase Elimination Rate Constant (β) of ABBV-382
timeFrame: Up to Day 112
measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-382
timeFrame: Up to Day 112
measure: Anti-Drug Antibody (ADA) of ABBV-382
timeFrame: Up to Day 112
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital /ID# 264785
state: Shanghai
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: