Healthy VolunteersPhase 1NCT06009237
A Study to Assess Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Participants
A Phase 1 study testing ABBV-903 in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
Trial summary
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 subjects. 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-903
- 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
- 23 Aug 2023to 30 Oct 2023
- 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
- Healthy Japanese or Han Chinese male or female; age is between 18 and 65 years, inclusive at the time of screening.
- Han Chinese subject must be first-generation Han Chinese of full Chinese parentage residing outside of China. Subjects must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
- OR
- Japanese subject must be first- or second generation Japanese of full Japanese parentage. First-generation subjects will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation subjects born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All subjects must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
- Body Mass Index (BMI) is >= 18.0 to <= 30.0 kg/m2 after rounding to the tenths decimal, at screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.
Who cannot join
- History of any clinically significant illness/infection/major febrile illness, hospitalization, as determined by the investigator, or any surgical procedure within 30 days prior to the first dose of study drug.
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma orlocalized carcinoma in situ of the cervix.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anaheim Clinical Trials LLC /ID# 257033
Anaheim, California, 92801-2658
About this study
Official title: A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Subjects
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 subjects.
- Conditions
- Healthy Volunteers
- Being tested
- ABBV-903, Placebo for ABBV-903
- Keywords
- ABBV-903, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-903Drug
Tablet; oral
Placebo for ABBV-903Drug
Tablet; oral
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Han-Chinese Participants ABBV-903 | Experimental | Han-Chinese participants will receive a single dose of ABBV-903. Receives: Drug: ABBV-903 |
| Part 1: Japanese Participants ABBV-903 | Experimental | Japanese participants will receive a single dose of ABBV-903. Receives: Drug: ABBV-903 |
| Part 1: Placebo | Experimental | Participants will receive a single dose of Placebo for ABBV-903. Receives: Drug: Placebo for ABBV-903 |
| Part 2: Japanese Participants ABBV-903 | Experimental | Japanese participants will receive ABBV-903 daily for 10 days. Receives: Drug: ABBV-903 |
| Part 2: Japanese Participants Placebo | Experimental | Japanese participants will receive placebo daily for 10 days. Receives: Drug: Placebo for ABBV-903 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of ABBV-903
Cmax of ABBV-903 will be assessed.
Measured: Up to Day 4
Time to Cmax (Tmax) of ABBV-903
Tmax of ABBV-903 will be assessed.
Measured: Up to Day 4
Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-903
Apparent terminal phase elimination rate constant (β) of ABBV-903 will be assessed.
Measured: Up to Day 4
Terminal Phase Elimination Half-life (t1/2) of ABBV-903
Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.
Measured: Up to Day 4
Area under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time t (AUC0-t) of ABBV-903
AUC0-t of ABBV-903 will be assessed.
Measured: Up to Day 4
AUC from Time 0 to Infinity (AUC0-inf) of ABBV-903
AUC0-inf of ABBV-903 will be assessed.
Measured: Up to Day 4
Number of Participants with 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.
Measured: Baseline to Day 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start23 Aug 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, 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
- NCT06009237
- Sponsor's protocol ID
- M24-227
- Status last verified
- Nov 2023
- First submitted
- 21 Aug 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chowdhury EA, Lee CM, Desai JM, Ali I, Orejudos A, Gupta SV, Ocampo CJ, Miller MG, Jayanth J, Schmidt JM, Salem AH, Mostafa NM. Pharmacokinetic profiling of limnetrelvir in non-Japanese and Japanese populations: results of two phase 1 single- and multiple-dose studies. Antimicrob Agents Chemother. 2026 May 6;70(5):e0144325. doi: 10.1128/aac.01443-25. Epub 2026 Mar 23.
PubMed 41870065
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Subjects
- ClinicalTrials.gov ID
- NCT06009237
- Acronym / sponsor ID
- M24-227
- Conditions
- Healthy Volunteers
- Keywords
- ABBV-903, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic considerations
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 24 Aug 2023 (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.
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 subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: Han-Chinese Participants ABBV-903 | Experimental | Drug: ABBV-903Han-Chinese participants will receive a single dose of ABBV-903. |
| Part 1: Japanese Participants ABBV-903 | Experimental | Drug: ABBV-903Japanese participants will receive a single dose of ABBV-903. |
| Part 1: Placebo | Experimental | Drug: Placebo for ABBV-903Participants will receive a single dose of Placebo for ABBV-903. |
| Part 2: Japanese Participants ABBV-903 | Experimental | Drug: ABBV-903Japanese participants will receive ABBV-903 daily for 10 days. |
| Part 2: Japanese Participants Placebo | Experimental | Drug: Placebo for ABBV-903Japanese participants will receive placebo daily for 10 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy Japanese or Han Chinese male or female; age is between 18 and 65 years, inclusive at the time of screening.
- Han Chinese subject must be first-generation Han Chinese of full Chinese parentage residing outside of China. Subjects must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
- OR
- Japanese subject must be first- or second generation Japanese of full Japanese parentage. First-generation subjects will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation subjects born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All subjects must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
Key exclusion criteria (2 listed)
- History of any clinically significant illness/infection/major febrile illness, hospitalization, as determined by the investigator, or any surgical procedure within 30 days prior to the first dose of study drug.
- Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma orlocalized carcinoma in situ of the cervix.
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-903Tablet; oral | Drug | Part 1: Han-Chinese Participants ABBV-903, Part 1: Japanese Participants ABBV-903, Part 2: Japanese Participants ABBV-903 |
| Placebo for ABBV-903Tablet; oral | Drug | Part 1: Placebo, Part 2: Japanese Participants Placebo |
Primary outcome
Maximum observed plasma concentration (Cmax) of ABBV-903
Time frame: Up to Day 4
Cmax of ABBV-903 will be assessed.
Time to Cmax (Tmax) of ABBV-903
Time frame: Up to Day 4
Tmax of ABBV-903 will be assessed.
Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-903
Time frame: Up to Day 4
Apparent terminal phase elimination rate constant (β) of ABBV-903 will be assessed.
Terminal Phase Elimination Half-life (t1/2) of ABBV-903
Time frame: Up to Day 4
Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.
Area under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time t (AUC0-t) of ABBV-903
Time frame: Up to Day 4
AUC0-t of ABBV-903 will be assessed.
AUC from Time 0 to Infinity (AUC0-inf) of ABBV-903
Time frame: Up to Day 4
AUC0-inf of ABBV-903 will be assessed.
Number of Participants with Adverse Events (AEs)
Time frame: Baseline to Day 34
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.
Results and safety
The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 41870065Chowdhury EA, Lee CM, Desai JM, Ali I, Orejudos A, Gupta SV, Ocampo CJ, Miller MG, Jayanth J, Schmidt JM, Salem AH, Mostafa NM. Pharmacokinetic profiling of limnetrelvir in non-Japanese and Japanese populations: results of two phase 1 single- and multiple-dose studies. Antimicrob Agents Chemother. 2026 May 6;70(5):e0144325. doi: 10.1128/aac.01443-25. Epub 2026 Mar 23.
- Individual participant dataSharing planned: No
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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-903 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 5 inclusion and 2 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 13 Nov 2023. 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: Strategic considerations). 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?
Maximum observed plasma concentration (Cmax) of ABBV-903 (time frame: Up to Day 4). 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?
On the ClinicalTrials.gov record for NCT06009237, which also lists 1 linked publication.
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 13 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.