A Study to Evaluate Adverse Events and How Single Ascending Doses of ABBV-141 Move Through the Body of Healthy Adult Western and Asian Participants

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Phase 1a Study to Evaluate the Safety and Pharmacokinetics of Single Ascending Doses of ABBV-141 in Healthy Adult Western and Asian Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06148181
• Other study ID #: M24-693
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 29, 2024
• Est. completion date: January 27, 2025

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in healthy adult Western and Asian participants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: January 27, 2025
• Est. primary completion date: January 27, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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).

• Body Mass Index (BMI) is = 18.0 to = 32.0 kg/m2 after rounding to the tenths decimal.

For Part 2 only:

-Han Chinese ethnicity or Japanese ethnicity based on the following criteria:

• Han Chinese: First-generation Han Chinese with both parents of Han Chinese descent.

• Japanese: First- or second-generation Japanese with both parents and all four grandparents born in Japan and of Japanese descent.

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, topical creams, or food.

Additionally for Part 1, only:

• Presence of foreign bodies, local irritation or infections, active skin diseases, tattoos, and/or scars on the thighs which may preclude the skin biopsy collection site planned as per schedule of activities.

• History of bruising easily, bleeding disorders, thrombocytopenia, or hypo-coagulation disorder.

• History of sensitivity to or allergies to adhesives or evidence of fragile or easily damaged skin.

• Evidence of hypertrophic scarring.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ABBV-141
Infusion; intravenous (IV)
• Placebo for ABBV-141
Infusion; IV
• ABBV-141
Injection; subcutaneous (SC)
• Placebo for ABBV-141
Injection; SC

Locations

Country	Name	City	State
United States	Acpru /Id# 261162	Grayslake	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of ABBV-141	Cmax of ABBV-141 will be assessed.	Up to Day 85
Primary	Time to Cmax (Tmax) of ABBV-141	Tmax of ABBV-141 will be assessed.	Up to Day 85
Primary	Area Under the Serum Concentration-time Curve (AUC) of ABBV-141 from time 0 to the time of last measurable concentration (AUCt)	AUCt of ABBV-141 will be determined.	Up to Day 85
Primary	AUC of ABBV-141 from Time 0 to Infinity (AUCinf)	AUCinf of ABBV-141 will be assessed.	Up to Day 85
Primary	Terminal Phase Elimination Rate Constant (ß) of ABBV-141	Terminal phase elimination rate constant (ß) of ABBV-141 will be assessed.	Up to Day 85
Primary	Terminal Phase Elimination Half-life (t1/2) of ABBV-141	Terminal phase elimination half-life (t1/2) of ABBV-141 will be assessed.	Up to Day 85
Primary	Dose Normalized Cmax of ABBV-141	Dose normalized Cmax of ABBV-141 will be assessed.	Up to Day 85
Primary	Dose Normalized AUC of ABBV-141	Dose normalized AUC of ABBV-141 will be assessed.	Up to Day 85
Primary	Number of Adverse Events (AEs)	An adverse event (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.	Baseline to Day 85

External Links

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