Safety, Tolerability and Pharmacokinetics of Oral Doses of RP3128 of Rhizen Pharmaceuticals

Inclusion Criteria

• •Male and non-childbearing female subjects (SAD/MAD) and male and non-childbearing female patients with mild asthma;
• •Healthy subjects as determined by past medical history, vitals, physical examination and 12-lead ECG, clinical laboratory tests.
• •Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥50 kg;
• •Non-smokers or ex-smokers
• •Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the subject; able to comply with protocol requirements and or study procedure;
• •Negative screen for drugs of abuse and alcohol at screening and on admission.
• •Male subjects should agree not to donate sperm for 3 months post dose; and
• •Female partners (of child bearing potential) of male subjects should use 2 methods of highly effective contraception for 3 months post last
• •Additionally for POC
• •Pre- bronchodilator Forced expiratory volume in 1 sec( FEV1) of \> 70% (adjusted for age, sex and race)
• •Steroid naïve subjects with history of mild asthma that satisfy the Global Initiative for Asthma (GINA) definition of asthma, but otherwise healthy.