A Phase 1 interventional study of ABBV-243 and Placebo in Healthy Volunteers, sponsored by AbbVie. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-12.
Sponsored by AbbVie · Phase 1, Interventional, and Basic science
The objective of this study is to assess the safety, tolerability, pharmacokinetics and immunogenicity of either single ascending intravenous (IV) doses of ABBV-243 or single ascending subcutaneous (SC) doses of ABBV-243 in healthy adult participants (Part 1), and a single intravenous (IV) dose in healthy Asian adult volunteers (Part 2
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Females, Non-Childbearing Potential are eligible as defined by meeting the following criteria:
Females, Childbearing Potential are defined as all other females who do not meet the above criteria and must adhere to the following:
Healthy Japanese and Han Chinese male or female; between 18 and 60 years of age, inclusive at the time of Screening.
- Han Chinese participants must be first- or second-generation Han Chinese of full Chinese parentage. First-generation participants are defined as those born in China to two parents and four grandparents also born in China of full Chinese descent. Second-generation participants are defined as those born outside of China to two parents and four grandparents born in China of full Chinese descent.
OR
- Japanese participants must be first- or second-generation Japanese of full Japanese parentage. First-generation participants 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.
Exclusion Criteria:
Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1
Drug: ABBV-243 · Drug: Placebo
Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1
Drug: ABBV-243 · Drug: Placebo
Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent, on Day 1
Drug: ABBV-243 · Drug: Placebo
Participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1
Drug: ABBV-243 · Drug: Placebo
Participants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1
Drug: ABBV-243 · Drug: Placebo
Participants will receive either a single subcutaneous (SC) dose of ABBV-243, or the placebo equivalent, on Day 1
Drug: ABBV-243 · Drug: Placebo
Han Chinese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1
Drug: ABBV-243 · Drug: Placebo
Japanese participants will receive either a single intravenous (IV) dose of ABBV-243, or the placebo equivalent. on Day 1
Drug: ABBV-243 · Drug: Placebo
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Subcutaneous (SC) Injection
Subcutaneous (SC) Injection
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Day 204
Maximum Observed Serum Concentration (Cmax) of ABBV-243
Maximum observed serum concentration (Cmax) of ABBV-243
Time frame: Up to Day 204
Time to Cmax (Tmax) of ABBV-243
Time to Cmax (Tmax) of ABBV-243
Time frame: Up to Day 204
Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-243
Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-243
Time frame: Up to Day 204
Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-243
AUC from time 0 to infinite time (AUCinf) of ABBV-243
Time frame: Up to Day 204
Terminal Phase Elimination Rate Constant (β) of ABBV-243
Terminal phase elimination rate constant of ABBV-243
Time frame: Up to Day 204
Terminal Phase Elimination Half-Life (t1/2) of ABBV-243
Terminal phase elimination half-life of ABBV-243
Time frame: Up to Day 204
Anti-Drug Antibody (ADA) of ABBV-243
Confirmed Positive ADA Results.
Time frame: Up to Day 204
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AbbVie