Dysautonomia International

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

Purpose

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.

Condition

Healthy Volunteers

Eligibility

Eligible Ages: Between 18 Years and 55 Years
Eligible Sex: All
Accepts Healthy Volunteers: Yes

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.

Study Design

Phase: Phase 1
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Basic Science
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Part 1, Group 1: ABBV-313 or Placebo	Participants will receive a single dose of ABBV-313 or Placebo	Drug: ABBV-313 Injection Drug: Placebo Injection
Experimental Part 1, Group 2: ABBV-313 or Placebo	Participants will receive a single dose of ABBV-313 or Placebo	Drug: ABBV-313 Injection Drug: Placebo Injection
Experimental Part 1, Group 3: ABBV-313 or Placebo	Participants will receive a single dose of ABBV-313 or Placebo	Drug: ABBV-313 Infusion Drug: Placebo Infusion
Experimental Part 1, Group 4: ABBV-313 or Placebo	Participants will receive a single dose of ABBV-313 or Placebo	Drug: ABBV-313 Infusion Drug: Placebo Infusion
Experimental Part 1, Group 5: ABBV-313 or Placebo	Participants will receive a single dose of ABBV-313 or Placebo	Drug: ABBV-313 Injection Drug: Placebo Injection
Experimental Part 1, Group 6: ABBV-313 or Placebo	Participants will receive a single dose of ABBV-313 or Placebo	Drug: ABBV-313 Infusion Drug: Placebo Infusion
Experimental Part 2, Group 7: ABBV-313 or Placebo	Participants will receive multiple doses of ABBV-313 or Placebo	Drug: ABBV-313 Injection Drug: Placebo Injection
Experimental Part 2, Group 8: ABBV-313 or Placebo	Participants will receive multiple doses of ABBV-313 or Placebo	Drug: ABBV-313 Injection Drug: Placebo Injection

Recruiting Locations

Acpru /Id# 283495
Grayslake, Illinois 60030

More Details

Status: Recruiting
Sponsor: AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.