A Study to Evaluate if ID-085 is Safe, Its Fate in the Body as Well as Its Potential Effects on the Body in Healthy Subjects

Study Overview
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Brief Summary
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The objective of this study is to evaluate the tolerability, safety, and pharmacokinetic of single- and multiple-ascending doses of ID-085 in healthy subjects.

Detailed Description
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The study is designed in two parts, A and B. Part A: single-center, double-blind, randomized, placebo-controlled, single ascending dose. Part B: single-center, double-blind, randomized, placebo-controlled, multiple ascending dose.

Official Title
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A Two-part Single-center, Phase 1 Study to Assess the Tolerability, Safety, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Ascending Single and Multiple Doses of ID-085 in Healthy Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: ID-085
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent in the local language prior to any study-mandated procedure. Healthy male subjects for Part A, healthy male and female subjects for Part B aged between 18 and 55 years (inclusive) at screening. No clinically significant findings on physical examination at screening. Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening. Exclusion Criteria: History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed). Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions. Pregnant or lactating women. Known allergic reactions or hypersensitivity to the study treatment or drugs of the same class, or any of the excipients. Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ID-085, single ascending dose (Part A)<br>ID-085 administered at different single dose levels in a sequential manner, and in a maximum of 6 dose levels starting from 10 mg (number of cohorts and dose levels will depend on the safety and pharmacokinetic results of the previous cohort) | Drug: ID-085<br>* Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg<br>|
| Placebo Comparator: Placebo, single ascending dose (Part A)<br>Matched placebo administered as single ascending doses in parallel to ID-085 | Drug: Placebo oral capsule<br>* Placebo capsules matching ID-085 capsules<br>|
| Experimental: ID-085 multiple ascending dose (Part B)<br>ID-085 administered in a twice daily (b.i.d.) dosing regimen at multiple dose levels. The starting dose will be either 10 or 30 mg and will be selected on the basis of the safety and pharmacokinetic results of the part A | Drug: ID-085<br>* Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg<br>|
| Placebo Comparator: Placebo, multiple ascending dose (Part B)<br>Matched placebo administered as single ascending doses in parallel to ID-085 | Drug: Placebo oral capsule<br>* Placebo capsules matching ID-085 capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in PQ/PR interval (ms) | ECG variables are to be recorded using a standard 12-lead ECG | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | 
| Changes from baseline in QRS interval (ms) | ECG variables are to be recorded using a standard 12-lead ECG | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | 
| Changes from baseline in QT corrected for Bazett's formula (QTcB) interval (ms) | ECG variables are to be recorded using a standard 12-lead ECG | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | 
| Changes from baseline in RR interval (ms) | ECG variables are to be recorded using a standard 12-lead ECG | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | 
| Changes from baseline in heart rate (bpm) | ECG variables are to be recorded using a standard 12-lead ECG | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | 
| Changes from baseline in supine systolic blood pressure | mm Hg | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | 
| Changes from baseline in supine diastolic blood pressure | mm Hg | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | 
| Changes from baseline in supine pulse rate | bpm | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | 
| Changes from baseline in body weight | kg | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | 
| Number of patients with treatment-emergent AEs and SAEs for each treatment period | Treatment-emergent AEs and treatment-emergent serious AEs | up to 48 hours post-dose (Part A); up to Day 10 (Part B) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) |  | up to Day 3 (Part A), up to Day 10 (Part B) | 
| Time to reach Cmax (tmax) |  | up to Day 3 (Part A), up to Day 10 (Part B) | 
| Terminal half-life [t(1/2)] |  | up to Day 3 (Part A), up to Day 10 (Part B) | 
| Area under the plasma concentration-time curve from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) |  | up to Day 3 (Part A), up to Day 10 (Part B) |