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Recruiting NCT07673120

A Study to Assess Safety, Tolerability, and How Single and Multiple Injections or Infusions of ABBV-313 Affects the Body of Adult Participants

Phase I Interventional Healthy Volunteers

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-313, Placebo, ABBV-313, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 55 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 Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses and Multiple Doses of ABBV-313

Overview

The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple doses of ABBV-313 in healthy adult participants.

Interventions

  • Drug ABBV-313
    Injection
  • Drug Placebo
    Injection
  • Drug ABBV-313
    Infusion
  • Drug Placebo
    Infusion

Primary outcome measures

  • Number of Participants with Adverse Events (AEs) [Time frame: Up to Approximately Day 329]
  • Maximum Observed Plasma Concentration (Cmax) of ABBV-313 [Time frame: Up to Approximately Day 329]
  • Time to Cmax (Tmax) of ABBV-313 [Time frame: Up to Approximately Day 329]
  • Terminal Phase Elimination Rate Constant (Beta) of ABBV-313 [Time frame: Up to Approximately Day 329]
  • Terminal Phase Elimination Half-Life (t1/2) of ABBV-313 [Time frame: Up to Approximately Day 329]
  • Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-313 [Time frame: Up to Approximately Day 329]

Eligibility criteria

Inclusion criteria

  • BMI is >= 18.0 to <= 29.9 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 ECG.

Exclusion criteria

  • History of any clinically significant sensitivity or allergy to any medication or food.
  • 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 treatment.
  • Participant has prior exposure to ABBV-313 within the past 300 days.

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
Parallel assignment
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Acpru /Id# 283495 — Grayslake

Identifiers

NCT: NCT07673120 · M26-216

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗