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ABBV-903 for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to day 34

Awards & highlights

Study Summary

This trial tests how a drug affects healthy adults in Japan and China, looking at safety, how it's absorbed, and how well it's tolerated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to day 34

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to day 34

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 34 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUC from Time 0 to Infinity (AUC0-inf) of ABBV-903

Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-903

Area under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time t (AUC0-t) of ABBV-903

+4 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part 2: Japanese Participants PlaceboExperimental Treatment1 Intervention

Japanese participants will receive placebo daily for 10 days.

Group II: Part 2: Japanese Participants ABBV-903Experimental Treatment1 Intervention

Japanese participants will receive ABBV-903 daily for 10 days.

Group III: Part 1: PlaceboExperimental Treatment1 Intervention

Participants will receive a single dose of Placebo for ABBV-903.

Group IV: Part 1: Japanese Participants ABBV-903Experimental Treatment1 Intervention

Japanese participants will receive a single dose of ABBV-903.

Group V: Part 1: Han-Chinese Participants ABBV-903Experimental Treatment1 Intervention

Han-Chinese participants will receive a single dose of ABBV-903.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ABBV-903

2023

Completed Phase 1

~140

Placebo for ABBV-903

2023

Completed Phase 1

~110

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

501,020 Total Patients Enrolled

ABBVIE INC.Study DirectorAbbVie

394 Previous Clinical Trials

145,854 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

May I join the current clinical trial?

"Patients who hope to be considered for this trial must be in good health and within the age range of 18-65. Around 42 individuals are being recruited into the study."

Answered by AI

Is there still an opportunity to enroll in this research?

"According to the clinicaltrials.gov listing, this trial is still actively looking for participants since its original posting on August 23rd 2023 and last update on September 15th of that same year."

Answered by AI

Has the FDA issued a certification for Part 1: Han-Chinese Participants ABBV-903?

"Due to the limited evidence for safety and efficacy associated with ABBV-903, our team rated its risk level at 1 on a scale of 1 - 3."

Answered by AI

Is the age criteria for this research study limited to those over 35 years old?

"The criteria for this trial dictates that eligible participants must be aged 18 to 65. Additionally, there are 63 trials available for minors and 404 investigational studies dedicated to individuals over the age of 65."

Answered by AI

How many participants are being monitored in this research effort?

"Indeed, the information on clinicaltrials.gov affirms that this medical trial is actively enrolling patients. This research was uploaded to the website on August 23rd 2023 and amended most recently on September 15th 2023. The study needs 42 participants from one site to complete its goals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Participants

2023. "A Study to Assess Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06009237.