Not provided
Not provided
Not provided
Not provided
Not provided
Strategic considerations
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Han-Chinese Participants ABBV-903 | Experimental | Han-Chinese participants will receive a single dose of ABBV-903. |
|
| Part 1: Japanese Participants ABBV-903 | Experimental | Japanese participants will receive a single dose of ABBV-903. |
|
| Part 1: Placebo | Experimental | Participants will receive a single dose of Placebo for ABBV-903. |
|
| Part 2: Japanese Participants ABBV-903 | Experimental | Japanese participants will receive ABBV-903 daily for 10 days. |
|
| Part 2: Japanese Participants Placebo | Experimental | Japanese participants will receive placebo daily for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-903 | Drug | Tablet; oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of ABBV-903 | Cmax of ABBV-903 will be assessed. | Up to Day 4 |
| Time to Cmax (Tmax) of ABBV-903 | Tmax of ABBV-903 will be assessed. | 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. | 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. | 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. | Up to Day 4 |
| AUC from Time 0 to Infinity (AUC0-inf) of ABBV-903 | AUC0-inf of ABBV-903 will be assessed. | 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. | Baseline to Day 34 |
Not provided
Not provided
Inclusion Criteria:
- Healthy Japanese or Han Chinese male or female; age is between 18 and 65 years, inclusive at the time of screening.
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials LLC /ID# 257033 | Anaheim | California | 92801-2658 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41870065 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo for ABBV-903 | Drug | Tablet; oral |
|