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Recruiting NCT07736638

A Study to Assess the Safety, Tolerability and How Single Ascending Doses of ABBV-859 Moves Through the Body of Healthy Adult Participants

Phase I Interventional Healthy Volunteer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ABBV-859, Placebo for ABBV-859, ABBV-859, Placebo for ABBV-859.
Who it may be relevant to
Registry conditions: Healthy Volunteer. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A First-in-Human, Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABBV-859 After Single Ascending Doses in Healthy Adult Subjects

Overview

The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-859 after single ascending doses in healthy adult volunteers.

Interventions

  • Drug ABBV-859
    Oral Tablet
  • Drug Placebo for ABBV-859
    Oral Tablet
  • Drug ABBV-859
    Intravenous (IV) Infusion
  • Drug Placebo for ABBV-859
    Intravenous (IV) Infusion

Primary outcome measures

  • Number of Participants with Adverse Events (AEs) [Time frame: Up to 99 Days]
  • Maximum Observed Serum Concentration (Cmax) of ABBV-859 [Time frame: Up to 99 Days]
  • Time to Cmax (Tmax) of ABBV-859 [Time frame: Up to 99 Days]
  • Terminal Phase Elimination Rate Constant (Beta) of ABBV-859 [Time frame: Up to 99 Days]
  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-859 [Time frame: Up to 99 Days]
  • Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-859 [Time frame: Up to 99 Days]
  • AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-859 [Time frame: Up to 99 Days]
  • Apparent Clearance (CL/F) ABBV-859 [Time frame: Up to 99 Days]
  • Antidrug Antibody (ADA) [Time frame: Up to 99 Days]

Eligibility criteria

Inclusion criteria

  • Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
  • Body Mass Index (BMI) is >= 18.0 to <= 32 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.
  • A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead Electrocardiogram (ECG).

Exclusion criteria

  • History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, endocrine, immunological, pulmonary, metabolic, neurological or psychiatric disease or disorder, or any uncontrolled medical illness.
  • History of any clinically significant sensitivity or allergy to any medication or food.
  • History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption \[e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.\].
  • 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 or evidence of active Tuberculosis disease or latent Tuberculosis infection.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • CenExel ACT- Anaheim Clinical Trials /ID# 284382 — Anaheim
  • Acpru /Id# 284029 — Grayslake

Identifiers

NCT: NCT07736638 · M25-924

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗