A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Participants
Status and phase
Enrolling
Phase 1
Conditions
Healthy Volunteers
Treatments
Drug: Placebo
Drug: ABBV-277
Details and patient eligibility
About
The objective of this study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK ) properties following a single dose of ABBV-277 in healthy adult participants.
Enrollment
40 estimated patients
Sex
All
Ages
18 to 65 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Body weight ≥ 35 kg
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile neurological examination, and a 12-lead ECG
Exclusion criteria
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- Participant must meet pregnancy/conception/partner considerations criteria as detailed in the eligibility section.
- Participants using any medications, vitamins and/or herbal supplements within the 14-day period prior to study drug administration or within 5 half-lives of the respective medication, whichever is longer.
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
- History of suicidal ideation currently or within one year prior to study drug administration as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the C - SSRS completed at screening, or any history of suicide attempts within the last two years.
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Sequential Assignment
Masking
Triple Blind
40 participants in 10 patient groups
Group 1: ABBV-277-Dose A
Experimental group
Description:
Participants will receive ABBV-277 Dose A on day 1 and followed for 196 days
Treatment:
Drug: ABBV-277
Group 1: Placebo
Experimental group
Description:
Participants will receive Placebo on day 1 and followed for 196 days
Treatment:
Drug: Placebo
Group 2: ABBV-277-Dose B
Experimental group
Description:
Participants will receive ABBV-277 Dose B on day 1 and followed for 196 days
Treatment:
Drug: ABBV-277
Group 2: Placebo
Experimental group
Description:
Participants will receive Placebo on day 1 and followed for 196 days
Treatment:
Drug: Placebo
Group 3: ABBV-277-Dose C
Experimental group
Description:
Participants will receive ABBV-277 Dose C on day 1 and followed for 196 days
Treatment:
Drug: ABBV-277
Group 3: Placebo
Experimental group
Description:
Participants will receive Placebo on day 1 and followed for 196 days
Treatment:
Drug: Placebo
Group 4: ABBV-277-Dose D
Experimental group
Description:
Participants will receive ABBV-277 Dose D on day 1 and followed for 196 days
Treatment:
Drug: ABBV-277
Group 4: Placebo
Experimental group
Description:
Participants will receive Placebo on day 1 and followed for 196 days
Treatment:
Drug: Placebo
Group 5: ABBV-277-Dose E
Experimental group
Description:
Participants will receive ABBV-277 Dose E on day 1 and day 2 and followed for 196 days
Treatment:
Drug: ABBV-277
Group 5: Placebo
Experimental group
Description:
Participants will receive Placebo on day 1 and day 2 and followed for 196 days
Treatment:
Drug: Placebo
Trial contacts and locations
1
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Central trial contact
ABBVIE CALL CENTER
Data sourced from clinicaltrials.gov
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