A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers an… (NCT06218784) | Clinical Trial Compass
RecruitingPhase 1
A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and PHN Patients.
Australia64 participantsStarted 2022-11-11
Plain-language summary
This study is a 3-part, Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamic properties of iN1011-N17 after Oral Administration in Healthy Volunteers and Post-Herpetic Neuralgia patients, and to assess the relative bioavailability of Mesylate vs Hydrochloride salt capsules of iN1011-N17 in Healthy volunteers.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Healthy male and female adults, aged 18 to 55 years of age (inclusive) at the time of 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 45 kg (inclusive).
✓. Clinically acceptable pulse rate, RR, and tympanic body temperature (pulse rate between 45 and 100 beats per minute \[bpm\]; SBP between 90 and 140 mmHg; DBP between 50 and 90 mmHg; RR between 12 and 22 breaths/min; tympanic body temperature between 35.5°C and 37.7°C at Screening and Day -1). Measurements are to be recorded after a minimum of 5 minutes of resting in sitting or supine position
✓. 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.
✓. All participants (excluding those who are exclusively in same-sex relationships, who are postmenopausal or have an exclusive partner who is postmenopausal) must agree to use a highly effective method of contraception throughout the study and for at least 30 days for females or 90 days for males after the last dose of IP. Female participants must not be breastfeeding, lactating, or pregnant during the study period.
✓. Cognitively capable of understanding the provided information and able to fully comply with protocol requirements.
✓. Written informed consent prior to the commencement of any study procedures.
✓. Willing and able to perform the necessary visits to the investigational site/institution.
Exclusion criteria
What they're measuring
1
Incidence, severity, and causality of AEs and serious AEs (SAEs)
Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
2
Incidence of Physical examination abnormalities
Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
3
Incidence of Vital signs abnormalities
Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
4
Incidence of 12-lead ECG abnormalities
Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
5
Incidence of Continous cardiac telemetry abnormalities
Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
6
Incidence of Laboratory tests abnormalities
Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days
. Presence or history of carcinoma, hepatic, renal, neurological, pulmonary (except for childhood asthma), endocrine, hematologic, cardiovascular, or genitourinary disease that, in the opinion of the Investigator, may affect the evaluation of the IP or place the participant at undue risk (except for conditions that are stable on medications).
✕. Presence of any underlying physical or psychiatric condition (except for conditions that are stable on medications) that, in the opinion of the Investigator, would undermine participant 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 PK characteristics of the IP.
✕. Presence or history of central nervous system disease that may affect assessment of safety and PK characteristics of the IP.
✕. Presence of herniated disc (inter-vertebral, cervical or both) or history of related disease that, in the opinion of the Investigator, may affect assessment of safety and PK characteristics of the IP.
✕. History of hypersensitivity to iN1011-N17 or to any of its components.
✕. History of allergy or sensitivity to sulfonamides, hay fever, asthma, eczema, food allergies and/or allergies to other medications. Participants with asymptomatic, untreated, seasonal allergies at the time of dosing may be considered for inclusion on a case-by-case basis- PI and Sponsor approval must be obtained prior to randomization.
✕. Any abnormal 12-lead ECG findings at Screening and Day -1, deemed by the Investigator or designee to be clinically significant.