Healthy VolunteersPhase 1NCT05475821
Study to Assess Adverse Events and How Oral ABBV-990 Moves Through the Body of Adult Healthy Participants
A Phase 1 study testing ABBV-990 in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
Trial summary
This study will assess how safe ABBV-990 is and how ABBV-990 moves through the body of adult healthy participants. Adverse Events will be assessed. ABBV-990 is an investigational drug being developed for the treatment of SARS-CoV-2 infections. Participants are randomly assigned to one of the 5 treatment groups. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ABBV-990
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2022to 26 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2.
- Laboratory values meet the protocol-specified criteria.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
- In the opinion of the investigator, participant is a suitable candidate for enrollment in the study.
Who cannot join
- Have any clinically significant ECG abnormalities.
- History of any clinically significant sensitivity or allergy to any medication or food.
- Known active SARS-CoV-2 infection at screening and upon initial confinement.
- 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 drug.
- Currently enrolled in another interventional clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First in Human, Single Ascending Dose Study for the Assessment of Pharmacokinetics, Safety and Tolerability of ABBV-990 in Healthy Male and Female Subjects
This study will assess how safe ABBV-990 is and how ABBV-990 moves through the body of adult healthy participants. Adverse Events will be assessed.
ABBV-990 is an investigational drug being developed for the treatment of SARS-CoV-2 infections. Participants are randomly assigned to one of the 5 treatment groups. Each group receives different treatment. There is 1 in 4 chance that participants are assigned to placebo. Approximately 40 adult healthy volunteers will be enrolled in a single site in the United States.
Read more
Participants will receive oral tablet of ABBV-990 or matching placebo on Day 1 and followed for approximately 30 days.
Participants will be confined for 5 days. Adverse Events and blood tests will be performed.
- Conditions
- Healthy Volunteers
- Being tested
- ABBV-990, Placebo for ABBV-990
- Keywords
- Healthy Volunteers, CoronaVirus Disease-2019 (COVID-19), ABBV-990, SARS-CoV-2, Severe Acute Respiratory Syndrome Coronavirus-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-990Drug
Oral Tablet
Placebo for ABBV-990Drug
Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive ABBV-990 Dose A or matching placebo. Receives: Drug: ABBV-990; Drug: Placebo for ABBV-990 |
| Group 2 | Experimental | Participants will receive ABBV-990 Dose B or matching placebo. Receives: Drug: ABBV-990; Drug: Placebo for ABBV-990 |
| Group 3 | Experimental | Participants will receive ABBV-990 Dose C or matching placebo. Receives: Drug: ABBV-990; Drug: Placebo for ABBV-990 |
| Group 4 | Experimental | Participants will receive ABBV-990 Dose D or matching placebo. Receives: Drug: ABBV-990; Drug: Placebo for ABBV-990 |
| Group 5 | Experimental | Participants will receive ABBV-990 Dose E or matching placebo. Receives: Drug: ABBV-990; Drug: Placebo for ABBV-990 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Measured: Up to approximately 30 days
Maximum Observed Plasma Concentration (Cmax) of ABBV-990
Cmax of ABBV-990.
Measured: Up to approximately 5 days
Time to Cmax (Tmax) of ABBV-990
Tmax of ABBV-990.
Measured: Up to approximately 5 days
Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-990
Apparent terminal phase elimination rate constant of ABBV-990.
Measured: Up to approximately 5 days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-990
Terminal phase elimination half-life of ABBV-990.
Measured: Up to approximately 5 days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-990
AUCt of ABBV-990.
Measured: Up to approximately 5 days
AUC From Time 0 to Infinite Time (AUCinf) of ABBV-990
AUCinf of ABBV-990.
Measured: Up to approximately 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start25 Jul 2022
- Primary completion26 Sep 2022
- Study completion26 Sep 2022
Why it stopped: Company decision: re-evaluation of risk vs benefit (based on animal data)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475821
- Sponsor's protocol ID
- M23-661
- Status last verified
- Oct 2022
- First submitted
- 25 Jul 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First in Human, Single Ascending Dose Study for the Assessment of Pharmacokinetics, Safety and Tolerability of ABBV-990 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT05475821
- Acronym / sponsor ID
- M23-661
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, CoronaVirus Disease-2019 (COVID-19), ABBV-990, SARS-CoV-2, Severe Acute Respiratory Syndrome Coronavirus-2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision: re-evaluation of risk vs benefit (based on animal data)
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 26 Sep 2022 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess how safe ABBV-990 is and how ABBV-990 moves through the body of adult healthy participants. Adverse Events will be assessed.
ABBV-990 is an investigational drug being developed for the treatment of SARS-CoV-2 infections. Participants are randomly assigned to one of the 5 treatment groups. Each group receives different treatment. There is 1 in 4 chance that participants are assigned to placebo. Approximately 40 adult healthy volunteers will be enrolled in a single site in the United States.
Participants will receive oral tablet of ABBV-990 or matching placebo on Day 1 and followed for approximately 30 days.
Participants will be confined for 5 days. Adverse Events and blood tests will be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: ABBV-990, Drug: Placebo for ABBV-990Participants will receive ABBV-990 Dose A or matching placebo. |
| Group 2 | Experimental | Drug: ABBV-990, Drug: Placebo for ABBV-990Participants will receive ABBV-990 Dose B or matching placebo. |
| Group 3 | Experimental | Drug: ABBV-990, Drug: Placebo for ABBV-990Participants will receive ABBV-990 Dose C or matching placebo. |
| Group 4 | Experimental | Drug: ABBV-990, Drug: Placebo for ABBV-990Participants will receive ABBV-990 Dose D or matching placebo. |
| Group 5 | Experimental | Drug: ABBV-990, Drug: Placebo for ABBV-990Participants will receive ABBV-990 Dose E or matching placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m2.
- Laboratory values meet the protocol-specified criteria.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
- In the opinion of the investigator, participant is a suitable candidate for enrollment in the study.
Key exclusion criteria (5 listed)
- Have any clinically significant ECG abnormalities.
- History of any clinically significant sensitivity or allergy to any medication or food.
- Known active SARS-CoV-2 infection at screening and upon initial confinement.
- 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 drug.
- Currently enrolled in another interventional clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABBV-990Oral Tablet | Drug | Group 1, Group 2, Group 3, Group 4, Group 5 |
| Placebo for ABBV-990Oral Tablet | Drug | Group 1, Group 2, Group 3, Group 4, Group 5 |
Primary outcome
Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to approximately 30 days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Maximum Observed Plasma Concentration (Cmax) of ABBV-990
Time frame: Up to approximately 5 days
Cmax of ABBV-990.
Time to Cmax (Tmax) of ABBV-990
Time frame: Up to approximately 5 days
Tmax of ABBV-990.
Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-990
Time frame: Up to approximately 5 days
Apparent terminal phase elimination rate constant of ABBV-990.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-990
Time frame: Up to approximately 5 days
Terminal phase elimination half-life of ABBV-990.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-990
Time frame: Up to approximately 5 days
AUCt of ABBV-990.
AUC From Time 0 to Infinite Time (AUCinf) of ABBV-990
Time frame: Up to approximately 5 days
AUCinf of ABBV-990.
Results and safety
The study was stopped early (reason given: Company decision: re-evaluation of risk vs benefit (based on animal data)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABBV-990 in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company decision: re-evaluation of risk vs benefit (based on animal data)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Adverse Events (AEs) (time frame: Up to approximately 30 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.