A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers

Inclusion Criteria: 1. Healthy male and female adults aged 18 to 55 years (inclusive at the time of written informed consent). 2. Body mass index (BMI = body weight (kg)/\[height (m)\]2) between 18 kg/m2 and 32 kg/m2 (inclusive) at the time of Screening, and a minimum weight of 50 kg. 3. Clinical laboratory values within normal range as specified by the testing laboratory at Screening and Day -1, unless deemed not clinically significant by the Investigator. 4. Clinically acceptable blood pressure (BP), pulse, respiratory rate (RR), and body temperature (SBP between 90 and 140 mmHg; DBP between 40 and 90 mmHg; pulse between 40 and 100 bpm; RR between 10 and 22 breaths/min; body temperature between 35.5°C and 37.5°C) at Screening and Day -1. Measurements are to be recorded after a minimum of 5 minutes of resting in sitting or supine position. 5. Female subjects must be of non-child-bearing potential, defined as: 1. Surgically sterile (i.e., had a bilateral tubal ligation, hysterectomy, salpingectomy, or bilateral oophorectomy at least 6 months before the first dose of investigational product \[IP\]) or; 2. Postmenopausal for at least 1 year before the first dose of IP, and if they have follicle-stimulating hormone (FSH) levels in the postmenopausal range for the investigational site/institution. OR Female subjects of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1, and must not be breastfeeding, lactating or planning pregnancy during the study period. Female subjects must agree to use adequate contraception from Screening until 30 days after the last dose of IP. Adequate contraception is defined as a condom for the male partner combined with either: 1. Non-hormonal intrauterine device (IUD) 2. Vasectomized partner with documented azoospermia 90 days after procedure, if that partner is the sole sexual partner Male subjects who are sexually active must use a condom combined with use of a highly-effective method of contraception for the female partner. Acceptable highly-effective forms of contraception for partners of male subjects are as follows: 1. Hormonal methods of contraception including oral contraceptives containing estrogen and progesterone, a vaginal ring, injectable and implantable hormonal contraceptives, intrauterine hormone-releasing system (e.g. Mirena) and progesterone-only hormonal contraception associated with inhibition of ovulation. 2. Non-hormonal intrauterine devi…