Healthy VolunteersPhase 1NCT06148181
A Study to Evaluate Adverse Events and How Single Ascending Doses of ABBV-141 Move Through the Body of Healthy Adult Western and Asian Participants
A Phase 1 study testing ABBV-141 in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in healthy adult Western and Asian participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ABBV-141
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2024to 30 Dec 2024
- Phase
- Phase 1
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal.
- For Part 2 only:
- -Han Chinese ethnicity or Japanese ethnicity based on the following criteria:
- Han Chinese: First-generation Han Chinese with both parents of Han Chinese descent.
- Japanese: First- or second-generation Japanese with both parents and all four grandparents born in Japan and of Japanese descent.
Who cannot join
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication, topical creams, or food.
- Additionally for Part 1, only:
- Presence of foreign bodies, local irritation or infections, active skin diseases, tattoos, and/or scars on the thighs which may preclude the skin biopsy collection site planned as per schedule of activities.
- History of bruising easily, bleeding disorders, thrombocytopenia, or hypo-coagulation disorder.
- History of sensitivity to or allergies to adhesives or evidence of fragile or easily damaged skin.
- Evidence of hypertrophic scarring.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 1a Study to Evaluate the Safety and Pharmacokinetics of Single Ascending Doses of ABBV-141 in Healthy Adult Western and Asian Subjects
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in healthy adult Western and Asian participants.
- Conditions
- Healthy Volunteers
- Being tested
- ABBV-141, Placebo for ABBV-141
- Keywords
- ABBV-141, Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-141Drug
Infusion; intravenous (IV)
Placebo for ABBV-141Drug
Infusion; IV
ABBV-141Drug
Injection; subcutaneous (SC)
Placebo for ABBV-141Drug
Injection; SC
| Study group | Role | What they receive |
|---|---|---|
| Part 1, ABBV-141 (Intravenous [IV]) | Experimental | Western participants will receive a single IV dose of ABBV-141. Receives: Drug: ABBV-141 |
| Part 1, Placebo for ABBV-141 (IV) | Placebo comparator | Western participants will receive a single IV dose of placebo for ABBV-141. Receives: Drug: Placebo for ABBV-141 |
| Part 1, ABBV-141 (subcutaneous [SC]) | Experimental | Western participants will receive a single SC dose of ABBV-141. Receives: Drug: ABBV-141 |
| Part 1, Placebo for ABBV-141 (SC) | Placebo comparator | Western participants will receive a single SC dose of placebo for ABBV-141. Receives: Drug: Placebo for ABBV-141 |
| Part 2, ABBV-141 (IV) | Experimental | Asian participants will receive a single IV dose of ABBV-141. Receives: Drug: ABBV-141 |
| Part 2, Placebo for ABBV-141 (IV) | Placebo comparator | Asian participants will receive a single IV dose of placebo for ABBV-141. Receives: Drug: Placebo for ABBV-141 |
| Part 2, ABBV-141 (SC) | Experimental | Asian participants will receive a single SC dose of ABBV-141. Receives: Drug: ABBV-141 |
| Part 2, Placebo for ABBV-141 (SC) | Placebo comparator | Asian participants will receive a single SC dose of placebo for ABBV-141. Receives: Drug: Placebo for ABBV-141 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of ABBV-141
Cmax of ABBV-141 will be assessed.
Measured: Up to Day 85
Time to Cmax (Tmax) of ABBV-141
Tmax of ABBV-141 will be assessed.
Measured: Up to Day 85
Area Under the Serum Concentration-time Curve (AUC) of ABBV-141 from time 0 to the time of last measurable concentration (AUCt)
AUCt of ABBV-141 will be determined.
Measured: Up to Day 85
AUC of ABBV-141 from Time 0 to Infinity (AUCinf)
AUCinf of ABBV-141 will be assessed.
Measured: Up to Day 85
Terminal Phase Elimination Rate Constant (β) of ABBV-141
Terminal phase elimination rate constant (β) of ABBV-141 will be assessed.
Measured: Up to Day 85
Terminal Phase Elimination Half-life (t1/2) of ABBV-141
Terminal phase elimination half-life (t1/2) of ABBV-141 will be assessed.
Measured: Up to Day 85
Dose Normalized Cmax of ABBV-141
Dose normalized Cmax of ABBV-141 will be assessed.
Measured: Up to Day 85
Dose Normalized AUC of ABBV-141
Dose normalized AUC of ABBV-141 will be assessed.
Measured: Up to Day 85
Number of 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 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start29 Jan 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 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
- NCT06148181
- Sponsor's protocol ID
- M24-693
- Status last verified
- Jan 2025
- First submitted
- 20 Nov 2023
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No