Health TrialsbyHealthPanel

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

ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAbbVie

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ABBV-313

    Drug

    Injection

  • Placebo

    Drug

    Injection

  • ABBV-313

    Drug

    Infusion

  • Placebo

    Drug

    Infusion

Treatment groups

64 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Part 1, Group 1: ABBV-313 or PlaceboExperimental treatment 2 interventions
Group B: Part 1, Group 2: ABBV-313 or PlaceboExperimental treatment 2 interventions
Group C: Part 1, Group 3: ABBV-313 or PlaceboExperimental treatment 2 interventions
Group D: Part 1, Group 4: ABBV-313 or PlaceboExperimental treatment 2 interventions
Group E: Part 1, Group 5: ABBV-313 or PlaceboExperimental treatment 2 interventions
Group F: Part 1, Group 6: ABBV-313 or PlaceboExperimental treatment 2 interventions
Group G: Part 2, Group 7: ABBV-313 or PlaceboExperimental treatment 2 interventions
Group H: Part 2, Group 8: ABBV-313 or PlaceboExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with Adverse Events (AEs)

An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Time frame
Up to Approximately Day 329
2

Maximum Observed Plasma Concentration (Cmax) of ABBV-313

Cmax of ABBV-313.

Time frame
Up to Approximately Day 329
3

Time to Cmax (Tmax) of ABBV-313

Tmax of ABBV-313.

Time frame
Up to Approximately Day 329
4

Terminal Phase Elimination Rate Constant (Beta) of ABBV-313

Beta of ABBV-313.

Time frame
Up to Approximately Day 329

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AbbVie

Lead sponsor

Source ClinicalTrials.gov
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