A First-in-Human Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Maximum Plasma Concentration (Cmax) of ABBV-277
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Group 1: ABBV-277-Dose A
Participants will receive ABBV-277 Dose A on day 1 and followed for 196 days
Intervention: ABBV-277 (Drug)
Group 5: ABBV-277-Dose E
Participants will receive ABBV-277 Dose E on day 1 and day 2 and followed for 196 days
Intervention: ABBV-277 (Drug)
Group 1: Placebo
Participants will receive Placebo on day 1 and followed for 196 days
Intervention: Placebo (Drug)
Group 2: ABBV-277-Dose B
Participants will receive ABBV-277 Dose B on day 1 and followed for 196 days
Intervention: ABBV-277 (Drug)
Group 5: Placebo
Participants will receive Placebo on day 1 and day 2 and followed for 196 days
Intervention: Placebo (Drug)
Group 3: ABBV-277-Dose C
Participants will receive ABBV-277 Dose C on day 1 and followed for 196 days
Intervention: ABBV-277 (Drug)
Group 3: Placebo
Participants will receive Placebo on day 1 and followed for 196 days
Intervention: Placebo (Drug)
Group 2: Placebo
Participants will receive Placebo on day 1 and followed for 196 days
Intervention: Placebo (Drug)
Group 4: ABBV-277-Dose D
Participants will receive ABBV-277 Dose D on day 1 and followed for 196 days
Intervention: ABBV-277 (Drug)
Group 4: Placebo
Participants will receive Placebo on day 1 and followed for 196 days
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Maximum Plasma Concentration (Cmax) of ABBV-277
Time Frame: Up to approximately 9 days
Cmax of ABBV-277
Time to Cmax (Tmax) of ABBV-277
Time Frame: Up to approximately 9 days
Tmax of ABBV-277
Terminal Phase Elimination Rate Constant (Beta) of ABBV-277
Time Frame: Up to approximately 9 days
Terminal phase elimination rate constant (beta) of ABBV-277
Terminal Phase Elimination Half-Life (t1/2) of ABBV-277
Time Frame: Up to approximately 9 days
Terminal phase elimination half-life of ABBV-277
Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-277
Time Frame: Up to approximately 9 days
AUCt of ABBV-277
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-277
Time Frame: Up to approximately 9 days
AUCinf of ABBV-277
Number of Participants With Adverse Events (AEs)
Time Frame: Up to Day 196
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. The investigator assesses the relationship of each event to the use of study
Secondary Outcomes
No secondary outcomes reported