Clinical Trials in the USA / NCT06895343
Active, not recruiting
Phase 1
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
NCT06895343 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Healthy Volunteer
Investigational drug(s) / intervention(s)
ABBV-701: Subcutaneous
Placebo: Subcutaneous
ABBV-701: IV Infusion
Placebo: IV infusion
Study 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.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Number of Participants Experiencing Adverse Events — 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 — Up to approximately 47 weeks
Cmax of ABBV-701 - Time to Cmax (Tmax) of ABBV-701 — Up to approximately 47 weeks
Tmax of ABBV-701 - Apparent terminal phase elimination rate constant (β) of ABBV-701 — Up to approximately 47 weeks
(β) of ABBV-701 - Terminal Phase Elimination Half-Life (t1/2) of ABBV-701 — 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 — Up to approximately 47 weeks
AUCt of ABBV-701 - Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-701 — Up to approximately 47 weeks
AUCinf of ABBV-701
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| CenExel ACT- Anaheim Clinical Trials /ID# 278431 | Anaheim | California | |
| Acpru /Id# 273354 | Grayslake | Illinois |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06895343 on ClinicalTrials.gov ↗ ← All trials in the USA