Clinical trial · Interventional
A Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of AB801 in Healthy Volunteers
A Phase 1, Double-Blinded, Randomised, Placebo-Controlled, Single Ascending Dose (SAD) Study in Healthy Subjects to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of AB801
NCT06004921CI-TRIAL-00080294ARC-26completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary purpose of this study is to determine the safety and tolerability of AB801, and to understand the pharmacokinetic (PK) profile of AB801 when taken as a capsule and tablet in healthy volunteers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AB801 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1 - AB801 Dose A
- description
- Participants will receive a single dose of AB801 or placebo
- interventionNames
- Drug: AB801
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Cohort 2 - AB801 Dose B
- description
- Participants will receive a single dose of AB801 or placebo
- interventionNames
- Drug: AB801
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Cohort 3 - AB801 Dose C
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Key Inclusion Criteria: * Healthy as determined by medical evaluation by study physician * Body mass index (BMI) of 18.0 to 32.0 kilogram (kg)/meter (m)\^2 as measured at screening * Weight ≥ 50 kg at screening * Must agree to adhere to the protocol defined contraception requirements Key Exclusion Criteria: * Do not have suitable veins for multiple venepunctures/cannulation as assessed by the study physician * Prolonged QT interval defined as mean Corrected QT interval by Fridericia's formula (QTcF) ≥ 450 msec for males and \> 470 millisecond (msec) for females at screening and pre-dose * Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the study physician * Received any study medicine in a clinical research study within the last 90 days * Taking, or have taken, any prescribed or over-the-counter drugs including gastric acid reducing agents and including CYP3A inhibitor and/or inducers Note: Other protocol defined Inclusion/Exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.