A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Participants

NCT07136103 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: M24-934
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; ABBV-277

Outcome Measures

Primary Outcomes (7)

• Maximum Plasma Concentration (Cmax) of ABBV-277

  Cmax of ABBV-277

  Up to approximately 9 days

• Time to Cmax (Tmax) of ABBV-277

  Tmax of ABBV-277

  Up to approximately 9 days

• Terminal Phase Elimination Rate Constant (Beta) of ABBV-277

  Terminal phase elimination rate constant (beta) of ABBV-277

  Up to approximately 9 days

• Terminal Phase Elimination Half-Life (t1/2) of ABBV-277

  Terminal phase elimination half-life of ABBV-277

  Up to approximately 9 days

• Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-277

  AUCt of ABBV-277

  Up to approximately 9 days

• Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-277

  AUCinf of ABBV-277

  Up to approximately 9 days

• Number of Participants With 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. The investigator assesses the relationship of each event to the use of study

  Up to Day 196

Study Arms (10)

Group 1: ABBV-277-Dose A

EXPERIMENTAL

Participants will receive ABBV-277 Dose A on day 1 and followed for 196 days

Drug: ABBV-277

Group 1: Placebo

EXPERIMENTAL

Participants will receive Placebo on day 1 and followed for 196 days

Drug: Placebo

Group 2: ABBV-277-Dose B

EXPERIMENTAL

Participants will receive ABBV-277 Dose B on day 1 and followed for 196 days

Drug: ABBV-277

Group 2: Placebo

EXPERIMENTAL

Participants will receive Placebo on day 1 and followed for 196 days

Drug: Placebo

Group 3: ABBV-277-Dose C

EXPERIMENTAL

Participants will receive ABBV-277 Dose C on day 1 and followed for 196 days

Drug: ABBV-277

Group 3: Placebo

EXPERIMENTAL

Participants will receive Placebo on day 1 and followed for 196 days

Drug: Placebo

Group 4: ABBV-277-Dose D

EXPERIMENTAL

Participants will receive ABBV-277 Dose D on day 1 and followed for 196 days

Drug: ABBV-277

Group 4: Placebo

EXPERIMENTAL

Participants will receive Placebo on day 1 and followed for 196 days

Drug: Placebo

Group 5: ABBV-277-Dose E

EXPERIMENTAL

Participants will receive ABBV-277 Dose E on day 1 and day 2 and followed for 196 days

Drug: ABBV-277

Group 5: Placebo

EXPERIMENTAL

Participants will receive Placebo on day 1 and day 2 and followed for 196 days

Drug: Placebo

Interventions

ABBV-277 DRUG

• Intravenous (IV) infusion

Group 1: ABBV-277-Dose A; Group 2: ABBV-277-Dose B; Group 3: ABBV-277-Dose C; Group 4: ABBV-277-Dose D; Group 5: ABBV-277-Dose E

Placebo DRUG

• Intravenous (IV) infusion

Group 1: Placebo; Group 2: Placebo; Group 3: Placebo; Group 4: Placebo; Group 5: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 265681

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: August 19, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)