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Healthy VolunteerPhase 1NCT06632938

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

A Phase 1 study testing ABBV-382 in people with Healthy Volunteer, run by AbbVie at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
ABBV-382
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteChina
Study dates
8 Oct 2024to 15 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Xuhui Central Hospital /ID# 264785

    Shanghai, Shanghai Municipality, 200031

Other trials in China

About this study

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

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.

Being tested
ABBV-382, Placebo for ABBV-382
Keywords
Healthy Volunteer, ABBV-382

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-382Drug

    Subcutaneous (SC) Injection

  • ABBV-382Drug

    Intravenous (IV) Infusion

  • Placebo for ABBV-382Drug

    IV Infusion

  • Placebo for ABBV-382Drug

    SC Injection

Study groups in NCT06632938
Study groupRoleWhat they receive
ABBV-382 Dose AExperimentalParticipant 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.
Receives: Drug: ABBV-382
ABBV-382 Dose A PlaceboPlacebo comparatorParticipant 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.
Receives: Drug: Placebo for ABBV-382
ABBV-382 Dose BExperimentalParticipant 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.
Receives: Drug: ABBV-382
ABBV-382 Dose B PlaceboPlacebo comparatorParticipant 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.
Receives: Drug: Placebo for ABBV-382

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to Approximately Day 140

  2. Maximum Observed Serum Concentration (Cmax) of ABBV-382

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

    Measured: Up to Day 112

  3. Time to Cmax (Tmax) of ABBV-382

    Time to Cmax (Tmax) of ABBV-382.

    Measured: Up to Day 112

  4. 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.

    Measured: Up to Day 112

  5. 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.

    Measured: Up to Day 112

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

    Terminal phase elimination rate constant of ABBV-382.

    Measured: Up to Day 112

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

    Terminal phase elimination half-life of ABBV-382.

    Measured: Up to Day 112

  8. Anti-Drug Antibody (ADA) of ABBV-382

    Confirmed Positive ADA Results.

    Measured: Up to Day 112

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2024
  2. Study start8 Oct 2024
  3. Primary completion15 May 2025
  4. Study completion15 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06632938
Sponsor's protocol ID
M25-081
Status last verified
May 2025
First submitted
8 Oct 2024
Last updated
30 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-382 in people with Healthy Volunteer, run by AbbVie at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AEs) (time frame: Up to Approximately Day 140). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06632938.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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