SAD and MAD Study of AKB-9090 in Healthy Adult Participants

• AKB-9090 (Drug): AKB-9090 will be administered intravenously
• Placebo (Other): Matching Placebo administered intravenously

Primary outcomes

• Number of participants who will report serious Treatment emergent adverse events (TEAEs) and TEAEs [From First Dose to Day 7]
• Number of Participants with Clinically Significant Changes in Physical Examinations [From First Dose to Day 7]
• Number of Participants with Clinically Significant Changes in Vital Signs [From First Dose to Day 7]
• Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) [From First Dose to Day 7]
• Number of Participants with Clinically Significant Changes in Chemistry parameters [From First Dose to Day 7]
• Number of Participants with Clinically Significant Changes in Hematology Parameters [from first dose to Day 7]
• Number of Participants with Clinically Significant Changes in Lipid Parameters [From First Dose to Day 7]
• Number of Participants with Clinically Significant Changes in Coagulation Parameters [From First Dose to Day 7]
• Number of Participants with Clinically Significant Changes in Urinalysis Parameters [From First Dose to Day 7]

Secondary outcomes

• Stage 1 SAD Cohorts: Maximum observed plasma concentration (Cmax) of AKB-9090 [At Day 1]
• Stage 1 SAD Cohorts: Time of maximum plasma concentration (Tmax) of AKB-9090 [At Day 1]
• Stage 1 SAD Cohorts: Area under concentration time curve (AUC) from time 0 to the last observation (AUClast) of AKB-9090 [At Day 1]
• Stage 1 SAD Cohorts: Apparent body clearance (CL) of AKB-9090 [At Day 1]
• Stage 1 SAD Cohorts: AUC from time 0 to infinity (AUCinf) of AKB-9090 [At Day 1]
• Stage 1 SAD Cohorts: Terminal half-life (T1/2) of AKB-9090 [At Day 1]
• Stage 2 MAD Cohorts: Cmax of AKB-9090 [At Day 1 and Day 7]
• Stage 2 MAD Cohorts: Tmax of AKB-9090 [At Day 1 and Day 7]
• Stage 2 MAD Cohorts: AUC to 24 hours post-dose (AUC24) of AKB-9090 [At Day 1]
• Stage 2 MAD Cohorts: CL of AKB-9090 [At Day 1 and Day 7]
• Stage 2 MAD Cohorts: T1/2 of AKB-9090 [At Day 1 and Day 7]
• Stage 2 MAD Cohorts: AUC at Steady state (AUCss) of AKB-9090 [At Day 7]
• Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Erythropoietin (EPO) [Baseline (Day 1) and at 6, 12, 18, and 24 hours post-dose]
• Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Red Blood Cell Count (RBC) [Baseline (Day 1) and At Days 2, 8, and 13]
• Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Reticulocyte Count [Baseline (Day 1) and At Days 2, 8, and 13]
• Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - EPO [Baseline (Day 1 and Day 7) and at 6, 12, 18, and 24 hours post-dose]
• Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - RBC [Baseline (Day 1) and At Days 4, 8, 14, and 21]
• Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Reticulocyte Count [Baseline (Day 1) and At Days 4, 8, 14, and 21]

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

Key Inclusion Criteria:

* Healthy adult participants with no clinically significant findings, as judged by the investigator, based on physical examination, 12-lead ECG, alcohol breath test, and clinical laboratory tests (including serum chemistry, hematology, coagulation, urine drug screen, and urinalysis).
* Body mass index (BMI) greater than 18.5 and less than 32.0 kg/m\^2 at screening.
* In the Investigator's opinion, willing and able to provide written informed consent and comply with the all protocol requirements, including required confinement, outpatient visits, and protocol-specified restrictions (including refraining from major lifestyle changes) from signature of the informed consent form (ICF) through the last study visit.

Key Exclusion Criteria:

* Clinically significant metabolic, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatologic, urogenital, ophthalmologic, ear/nose/throat, psychiatric, or neurologic disorder.
* History of active or recurrent malignancy within 2 years before screening or during the screening period, or currently receiving treatment or suppressive therapy for cancer, except for:

  1. Treated basal cell carcinoma of the skin
  2. Curatively resected squamous cell carcinoma of the skin
  3. Treated colonic or cervical carcinoma in situ
* Abnormal ECG findings at screening, including:

  1. Severe bradycardia (heart rate <40 beats per minute) on any measurement
  2. Mean QT Interval Using Fridericia's Formula (QTcF) >450 msec for males or >470 msec for females
* Elevated laboratory values (>1.25 × upper limit of normal \[ULN\]) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatinine at the screening visit or at check-in.
* Evidence of acute or chronic hepatitis B (positive hepatitis B surface antigen) or hepatitis C infection (positive hepatitis C antibody and positive hepatitis C ribonucleic acid \[RNA\] test).
* Use of nicotine-containing products (including cigarettes, cigars, tobacco, gum, patches, vaping, and e-cigarettes), caffeine-containing foods or beverages, and alcohol-containing foods or beverages during study.

• Dr. Sophie Mckellar sophie.mckellar@nzcr.co.nz, Study director, New Zealand Clinical Research (NZCR)