ClinicalTrials.gg
Not yet recruitingNCT07935564Updated Nov 13, 2026

A Study to Assess the Adverse Events and How Oral ABBV-1606 Moves Through the Body of Healthy Adult Participants.

A Phase 1 interventional study of ABBV-1606 and Placebo in Healthy Volunteer, sponsored by AbbVie. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by AbbVie · Phase 1, Interventional, and Basic science

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1606 moves through the body of healthy adult participants.

02

Conditions studied

  • Healthy Volunteer

Keywords

  • Healthy Volunteer
  • ABBV-1606
03

In context

Lead sponsor

AbbVie is the lead sponsor of 977 studies on the registry; 136 are open to participants now.

Of its 358 completed or terminated interventional studies of FDA-regulated products, 215 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
  • Total body weight > 50.0 kg at Screening.
  • A condition of general good health, based upon the results of a medical history, physical examination, neurological examination, vital signs, laboratory profile, and a 12-lead .

Exclusion criteria

Exclusion Criteria:

  • History of any cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, immunological, neurological, pulmonary, metabolic, endocrine or psychiatric disease or disorder, active or chronic infectious diseases or any uncontrolled medical illness.
  • History of any vasculitis-related conditions, or any confirmed or connective tissue diseases (e.g., Systemic Lupus Erythematosus, Sjogren's Syndrome, inflammatory bowel disease, etc.) as per the Investigator judgement.
  • History of unexplained purpura or skin rash, or unexplained signs or symptoms suggestive of vasculitis (including, but not limited to, fever, weight loss, arthralgia or arthritis, myalgia, hematuria, abdominal pain, gastrointestinal bleeding, etc.) that is not resolved for at least 30 days prior to dosing.
  • History of any abnormal result for Antinuclear antibody (ANA) or Antineutrophil cytoplasmic antibody (ANCA) at Screening
  • Abnormal result for C-Reactive Protein (CRP) or Erythrocyte Sedimentation Rate (ESR), or fibrinogen > the (ULN) at Screening.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    ABBV-1606 or Placebo Group 1

    Participants will receive a single oral dose of ABBV-1606 or placebo group 1 on day 1.

    Drug: ABBV-1606 · Drug: Placebo

  • Experimental
    ABBV-1606 or Placebo Group 2

    Participants will receive a single oral dose of ABBV-1606 or placebo group 2 on day 1.

    Drug: ABBV-1606 · Drug: Placebo

  • Experimental
    ABBV-1606 or Placebo Group 3

    Participants will receive a single oral dose of ABBV-1606 or placebo group 3 on day 1.

    Drug: ABBV-1606 · Drug: Placebo

  • Experimental
    ABBV-1606 or Placebo Group 4

    Participants will receive a single oral dose of ABBV-1606 or placebo group 4 on day 1.

    Drug: ABBV-1606 · Drug: Placebo

  • Experimental
    ABBV-1606 or Placebo Group 5

    Participants will receive a single oral dose of ABBV-1606 or placebo group 5 on day 1.

    Drug: ABBV-1606 · Drug: Placebo

Interventions

  • DrugABBV-1606

    Oral Solution

  • DrugPlacebo

    Oral Solution

06

What researchers measure

Primary outcomes

  1. Number of Participants Experiencing Adverse Events

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

    Time frame: Up to approximately 35 days

  2. Maximum observed plasma concentration (Cmax) of ABBV-1606

    Cmax of ABBV-1606

    Time frame: Up to approximately 5 days

  3. Time to maximum observed plasma concentration (Cmax) (Tmax) of ABBV-1606

    Tmax of ABBV-1606

    Time frame: Up to approximately 5 days

  4. Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of ABBV-1606

    AUCt of ABBV-1606

    Time frame: Up to approximately 5 days

  5. Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of ABBV-1606

    AUCinf of ABBV-1606

    Time frame: Up to approximately 5 days

  6. Apparent terminal phase elimination constant (β) of ABBV-1606

    β of ABBV-1606

    Time frame: Up to approximately 5 days

  7. Terminal Phase Elimination Half-Life (t1/2) of ABBV-1606

    t1/2 of ABBV-1606

    Time frame: Up to approximately 5 days

  8. Apparent clearance (CL/F) of ABBV-1606

    CL/F of ABBV-1606

    Time frame: Up to approximately 5 days

  9. Apparent volume of distribution (Vz/F) of ABBV-1606

    Vz/F of ABBV-1606

    Time frame: Up to approximately 5 days

  10. Dose Normalized Cmax of ABBV-1606

    Dose Normalized Cmax of ABBV-1606 will be assessed.

    Time frame: Up to approximately 5 days

  11. Dose Normalized AUC of ABBV-1606

    Dose Normalized AUC of ABBV-1606 will be assessed.

    Time frame: Up to approximately 5 days

07

Study locations

1 site
  • Acpru /Id# 277795
    Grayslake, Illinois 60030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Jul 2027, 8 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2025
First posted
Nov 13, 2026
StartEst.
Nov 10, 2026
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2027
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07935564
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Nov 10, 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Nov 13, 2026

Study contacts

ABBVIE CALL CENTER
Contact
abbvieclinicaltrials@abbvie.com
844-663-3742
ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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