A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers (NCT05496205) | Clinical Trial Compass
CompletedPhase 1
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
Australia104 participantsStarted 2020-09-30
Plain-language summary
A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of iN1011-N17 after Oral Administration in Healthy Volunteers.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Healthy male and female adults aged 18 to 55 years (inclusive at the time of written informed consent).
✓. 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.
✓. 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.
✓. 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.
✓. Female subjects must be of non-child-bearing potential, defined as:
✓. 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;
✓. 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.
✓. Non-hormonal intrauterine device (IUD)
Exclusion criteria
✕. Presence or history of hepatic, renal, neurological, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease that, in the opinion of the Investigator, may affect the evaluation of the investigational product or place the participant at undue risk.
What they're measuring
1
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Day 1 to Day 8
2
Number of participants with abnormal physical examination findings
Timeframe: Screening, Day -1, Day 3, Day 8
3
Vital Signs (Blood Pressure)
Timeframe: Screening, Day -1, Day 1 (pre-dose and 2, 4, 8 hours pose-dose), Day 2 (prior PK sampling), Day 3 (prior PK sampling), Day 8
4
Vital Signs (Pulse)
Timeframe: Screening, Day -1, Day 1 (pre-dose and 2, 4, 8 hours pose-dose), Day 2 (prior PK sampling), Day 3 (prior PK sampling), Day 8
5
Vital Signs (Respiratory Rate)
Timeframe: Screening, Day -1, Day 1 (pre-dose and 2, 4, 8 hours pose-dose), Day 2 (prior PK sampling), Day 3 (prior PK sampling), Day 8
6
Vital Signs (Body temperature)
Timeframe: Screening, Day -1, Day 3 (prior PK sampling), Day 8
7
12-lead electrocardiogram(ECG)
Timeframe: Screening, Day -1, Day 1 (pre-dose and 1, 4, 8 hours pose-dose), Day 3 (prior PK sampling), Day 8
✕. Presence of any underlying physical or psychiatric condition that, in the opinion of the Investigator, would undermine subject compliance to protocol requirements.
✕. Presence or history of gastrointestinal disease (e.g., peptic ulcer, gastritis, gastric cramp, gastroesophageal reflex disease, Crohn's disease) or history of gastrointestinal surgery (except simple appendectomy or herniorrhaphy) that may affect assessment of safety and pharmacokinetic characteristics of the IP.
✕. History of hypersensitivity to iN1011-N17 or to any of its components.
✕. History of allergy or sensitivity to sulfonamides.
✕. Any abnormal 12-lead ECG findings at Screening and Day -1, deemed by the Investigator or designee to be clinically significant.
✕. Positive test for HBsAg, HCV, or HIV at Screening.
✕. Positive urine drug screen test (including: amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine and tetrahydrocannabinol) or alcohol breath test at Screening and Day -1.
Number of participants with abnormal Laboratory tests (Hematology)
Timeframe: Screening, Day -1, Day 3 prior to discharge, Day 8
9
Number of participants with abnormal Laboratory tests (Biochemistry))
Timeframe: Screening, Day -1, Day 3 prior to discharge, Day 8