ABBV-903 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the new drug ABBV-903 behaves in the body and checks for any side effects when administered in single or multiple doses. It includes different parts where some participants receive the drug, while others receive a placebo (a substance with no active medicine). The trial focuses on healthy adults without significant health issues. Individuals who have been healthy recently and do not have major illnesses might be suitable for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy volunteers, it might be expected that participants are not on any regular medications.
Is there any evidence suggesting that ABBV-903 is likely to be safe for humans?
Research has shown that ABBV-903 has undergone safety testing in healthy individuals. In earlier studies, ABBV-903 was generally well-tolerated. These studies examined the drug's movement through the body and monitored for side effects. Most participants did not report serious side effects. This suggests ABBV-903 may be safe for humans, but further research is necessary to confirm this. This trial is in its early stages, focusing primarily on ensuring the treatment's safety.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about ABBV-903 because it represents a potential breakthrough in how we approach treatment for its target condition. Unlike traditional treatments that might rely on well-known mechanisms, ABBV-903 may work through a novel pathway, offering a fresh angle on tackling the problem. Additionally, ABBV-903 is being evaluated in both single and multiple ascending doses, which could provide valuable insights into optimizing its effectiveness and safety profile. This innovative approach could enhance treatment outcomes and offer new hope for patients.
What evidence suggests that ABBV-903 could be effective?
Research has shown that treatments like ABBV-903, which target a protein called CD33, may help eliminate acute myeloid leukemia (AML) cells. This trial includes different arms where participants receive either ABBV-903 or a placebo to assess its safety and mechanism of action. While more detailed information on its effectiveness is needed, targeting CD33 appears promising for treating AML. Early results from similar treatments suggest that ABBV-903 has potential in fighting AML.23678
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single and multiple ascending doses of ABBV-903 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ABBV-903
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Participants in Part 3 will follow Sequence 2.
Participants in Part 3 will follow Sequence 1.
Participants will receive multiple ascending doses of placebo in Part 2.
Participants will receive multiple ascending doses of ABBV-903 in Part 2.
Participants will receive a single ascending dose of placebo in Part 1.
Participants will receive a single ascending dose of ABBV-903 in Part 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Citations
A Study to Assess the Mass Balance of [14C] ABBV-903 in ...
Study Plan Participants will receive ABBV-903 on Day 1. Cmax of ABBV-903 will be assessed. Tmax of ABBV-903 will be assessed.
A Study to Assess Adverse Events and How Single ...
The purpose of this study is to evaluate adverse events and tolerability of single and multiple doses of ABBV-903, and to assess how the drug moves through ...
NCT05691699 | A Study to Assess Adverse Events and ...
The purpose of this study is to evaluate adverse events and tolerability of single and multiple doses of ABBV-903, and to assess how the drug moves through the ...
A Study to Assess Drug-Drug Interaction Between ABBV ...
The main objective of this study is to assess the drug-drug interaction and pharmacokinetics of ABBV-903 and Midazolam in healthy adult participants.
A Study to Assess Adverse Events and How Single and ...
The research indicates that treatments targeting CD33, like ABBV-903, have shown effectiveness in eliminating acute myeloid leukemia cells by engaging the ...
A Study to Assess Pharmacokinetics, Safety, and ...
The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of ABBV-903 or placebo in healthy adult Japanese and Han Chinese ...
A Study to Assess the Mass Balance of [14C] ABBV-903 in ...
The purpose of this study is to evaluate the mass balance and safety of \[14C\] ABBV-903 in healthy male volunteers following a single oral dose administration.
8.
medchemexpress.com
medchemexpress.com/limnetrelvir.html?srsltid=AfmBOor1t7yGC2PxOHBRVnIRRDKiJdhQ5NNDxZI9nykasnOTUf6__8sVLimnetrelvir | MPro Inhibitor
Limnetrelvir (ABBV-903) is a MPro inhibitor. Limnetrelvir could be used in antiviral research. For research use only. We do not sell to patients.
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