Clinical Trials in the USA / NCT07736638
Recruiting
Phase 1
A Study to Assess the Safety, Tolerability and How Single Ascending Doses of ABBV-859 Moves Through the Body of Healthy Adult Participants
NCT07736638 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Healthy Volunteer
Investigational drug(s) / intervention(s)
ABBV-859Placebo for ABBV-859ABBV-859Placebo for ABBV-859
ABBV-859: Oral Tablet
Placebo for ABBV-859: Oral Tablet
ABBV-859: Intravenous (IV) Infusion
Placebo for ABBV-859: Intravenous (IV) Infusion
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Number of Participants with Adverse Events (AEs) — Up to 99 Days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product. - Maximum Observed Serum Concentration (Cmax) of ABBV-859 — Up to 99 Days
Cmax of ABBV-859 - Time to Cmax (Tmax) of ABBV-859 — Up to 99 Days
Time to Cmax (Tmax) of ABBV-859 - Terminal Phase Elimination Rate Constant (Beta) of ABBV-859 — Up to 99 Days
Beta of ABBV-859 - Terminal Phase Elimination Half-Life (t1/2) of ABBV-859 — Up to 99 Days
t1/2 of ABBV-859 - Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-859 — Up to 99 Days
AUCt of ABBV-859 - AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-859 — Up to 99 Days
AUCinf of ABBV-859 - Apparent Clearance (CL/F) ABBV-859 — Up to 99 Days
CL/F of ABBV-859 - Antidrug Antibody (ADA) — Up to 99 Days
Incidence and concentration of anti-drug antibodies.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| CenExel ACT- Anaheim Clinical Trials /ID# 284382 | Anaheim | California | Recruiting |
| Acpru /Id# 284029 | Grayslake | Illinois | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07736638 on ClinicalTrials.gov ↗ ← All trials in the USA