Healthy VolunteerPhase 1NCT06895343
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Subcutaneous or Intravenous Doses of ABBV-701 in Healthy Adult Western and Asian Participants
A Phase 1 study testing ABBV-701 in people with Healthy Volunteer, run by AbbVie at 2 sites in United States.
Trial summary
The main objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of single ascending doses of ABBV-701 in healthy adult western and Asian participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- ABBV-701
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Apr 2025to Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight is ≥ 35 kg and BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth's decimal.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG
- Part 2 and Part 4 only:
- For Japanese Participants:
- --Participant must be first or second-generation Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
- Han Chinese Participants:
- --Participant must be first or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
Who cannot join
- History of any clinically significant cardiovascular, respiratory (except mild asthma as a child), renal, endocrine, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CenExel ACT- Anaheim Clinical Trials /ID# 278431
Anaheim, California, 92801
Acpru /Id# 273354
Grayslake, Illinois, 60030
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses of ABBV-701 in Healthy Adult Western and Asian Subjects
The main objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of single ascending doses of ABBV-701 in healthy adult western and Asian participants.
- Conditions
- Healthy Volunteer
- Being tested
- ABBV-701, Placebo
- Keywords
- Healthy Volunteer, ABBV-701
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABBV-701Drug
Subcutaneous
PlaceboDrug
Subcutaneous
ABBV-701Drug
IV Infusion
PlaceboDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Group 1 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose A or placebo. Receives: Drug: ABBV-701; Drug: Placebo |
| Part 1: Group 2 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose B or placebo. Receives: Drug: ABBV-701; Drug: Placebo |
| Part 1: Group 3 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose C or placebo. Receives: Drug: ABBV-701; Drug: Placebo |
| Part 1: Group 4 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose D or placebo. Receives: Drug: ABBV-701; Drug: Placebo |
| Part 1: Group 5 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose E or placebo. Receives: Drug: ABBV-701; Drug: Placebo |
| Part 2: Group 6 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose E or placebo. Receives: Drug: ABBV-701; Drug: Placebo |
| Part 2: Group 7 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose E or placebo. Receives: Drug: ABBV-701; Drug: Placebo |
| Part 3: Group 8 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose C or placebo. Receives: Drug: ABBV-701; Drug: Placebo |
| Part 3: Group 9 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose E or placebo. Receives: Drug: ABBV-701; Drug: Placebo |
| Part 3: Group 10 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose F or placebo. Receives: Drug: ABBV-701; Drug: Placebo |
| Part 4: Group 11 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose F or placebo. Receives: Drug: ABBV-701; Drug: Placebo |
| Part 4: Group 12 ABBV-701 or Placebo | Experimental | Participants will receive a single dose of either ABBV-701 Dose F or placebo. Receives: Drug: ABBV-701; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events
An 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: Up to approximately 47 weeks
Maximum Plasma Concentration (Cmax) of ABBV-701
Cmax of ABBV-701
Measured: Up to approximately 47 weeks
Time to Cmax (Tmax) of ABBV-701
Tmax of ABBV-701
Measured: Up to approximately 47 weeks
Apparent terminal phase elimination rate constant (β) of ABBV-701
(β) of ABBV-701
Measured: Up to approximately 47 weeks
Terminal Phase Elimination Half-Life (t1/2) of ABBV-701
(t1/2) of ABBV-701
Measured: Up to approximately 47 weeks
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-701
AUCt of ABBV-701
Measured: Up to approximately 47 weeks
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-701
AUCinf of ABBV-701
Measured: Up to approximately 47 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start3 Apr 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- 100 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
- NCT06895343
- Sponsor's protocol ID
- M25-491
- Status last verified
- Feb 2026
- First submitted
- 20 Mar 2025
- Last updated
- 2 Mar 2026
- 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 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses of ABBV-701 in Healthy Adult Western and Asian Subjects
- ClinicalTrials.gov ID
- NCT06895343
- Acronym / sponsor ID
- M25-491
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, ABBV-701
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 Mar 2025 (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 main objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of single ascending doses of ABBV-701 in healthy adult western and Asian participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Part 1: Group 1 ABBV-701 or Placebo | Experimental | Drug: ABBV-701, Drug: PlaceboParticipants will receive a single dose of either ABBV-701 Dose A or placebo. |
| Part 1: Group 2 ABBV-701 or Placebo | Experimental | Drug: ABBV-701, Drug: PlaceboParticipants will receive a single dose of either ABBV-701 Dose B or placebo. |
| Part 1: Group 3 ABBV-701 or Placebo | Experimental | Drug: ABBV-701, Drug: PlaceboParticipants will receive a single dose of either ABBV-701 Dose C or placebo. |
| Part 1: Group 4 ABBV-701 or Placebo | Experimental | Drug: ABBV-701, Drug: PlaceboParticipants will receive a single dose of either ABBV-701 Dose D or placebo. |
| Part 1: Group 5 ABBV-701 or Placebo | Experimental | Drug: ABBV-701, Drug: PlaceboParticipants will receive a single dose of either ABBV-701 Dose E or placebo. |
| Part 2: Group 6 ABBV-701 or Placebo | Experimental | Drug: ABBV-701, Drug: PlaceboParticipants will receive a single dose of either ABBV-701 Dose E or placebo. |
| Part 2: Group 7 ABBV-701 or Placebo | Experimental | Drug: ABBV-701, Drug: PlaceboParticipants will receive a single dose of either ABBV-701 Dose E or placebo. |
| Part 3: Group 8 ABBV-701 or Placebo | Experimental | Drug: ABBV-701, Drug: PlaceboParticipants will receive a single dose of either ABBV-701 Dose C or placebo. |
| Part 3: Group 9 ABBV-701 or Placebo | Experimental | Drug: ABBV-701, Drug: PlaceboParticipants will receive a single dose of either ABBV-701 Dose E or placebo. |
| Part 3: Group 10 ABBV-701 or Placebo | Experimental | Drug: ABBV-701, Drug: PlaceboParticipants will receive a single dose of either ABBV-701 Dose F or placebo. |
| Part 4: Group 11 ABBV-701 or Placebo | Experimental | Drug: ABBV-701, Drug: PlaceboParticipants will receive a single dose of either ABBV-701 Dose F or placebo. |
| Part 4: Group 12 ABBV-701 or Placebo | Experimental | Drug: ABBV-701, Drug: PlaceboParticipants will receive a single dose of either ABBV-701 Dose F or placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Body weight is ≥ 35 kg and BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenth's decimal.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG
- Part 2 and Part 4 only:
- --Participant must be first or second-generation Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
- --Participant must be first or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
Key exclusion criteria (2 listed)
- History of any clinically significant cardiovascular, respiratory (except mild asthma as a child), renal, endocrine, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication or food.
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-701Subcutaneous | Drug | Part 1: Group 1 ABBV-701 or Placebo, Part 1: Group 2 ABBV-701 or Placebo, Part 1: Group 3 ABBV-701 or Placebo, Part 1: Group 4 ABBV-701 or Placebo, Part 1: Group 5 ABBV-701 or Placebo, Part 2: Group 6 ABBV-701 or Placebo, Part 2: Group 7 ABBV-701 or Placebo |
| PlaceboSubcutaneous | Drug | Part 1: Group 1 ABBV-701 or Placebo, Part 1: Group 2 ABBV-701 or Placebo, Part 1: Group 3 ABBV-701 or Placebo, Part 1: Group 4 ABBV-701 or Placebo, Part 1: Group 5 ABBV-701 or Placebo, Part 2: Group 6 ABBV-701 or Placebo, Part 2: Group 7 ABBV-701 or Placebo |
| ABBV-701IV Infusion | Drug | Part 3: Group 10 ABBV-701 or Placebo, Part 3: Group 8 ABBV-701 or Placebo, Part 3: Group 9 ABBV-701 or Placebo, Part 4: Group 11 ABBV-701 or Placebo, Part 4: Group 12 ABBV-701 or Placebo |
| PlaceboIV infusion | Drug | Part 3: Group 10 ABBV-701 or Placebo, Part 3: Group 8 ABBV-701 or Placebo, Part 3: Group 9 ABBV-701 or Placebo, Part 4: Group 11 ABBV-701 or Placebo, Part 4: Group 12 ABBV-701 or Placebo |
Primary outcome
Number of Participants Experiencing Adverse Events
Time frame: Up to approximately 47 weeks
An 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.
Maximum Plasma Concentration (Cmax) of ABBV-701
Time frame: Up to approximately 47 weeks
Cmax of ABBV-701
Time to Cmax (Tmax) of ABBV-701
Time frame: Up to approximately 47 weeks
Tmax of ABBV-701
Apparent terminal phase elimination rate constant (β) of ABBV-701
Time frame: Up to approximately 47 weeks
(β) of ABBV-701
Terminal Phase Elimination Half-Life (t1/2) of ABBV-701
Time frame: Up to approximately 47 weeks
(t1/2) of ABBV-701
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-701
Time frame: Up to approximately 47 weeks
AUCt of ABBV-701
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-701
Time frame: Up to approximately 47 weeks
AUCinf of ABBV-701
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- 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
2 sites 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-701 in people with Healthy Volunteer, run by AbbVie at 2 sites 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 7 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: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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 (time frame: Up to approximately 47 weeks). 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 2 Mar 2026.