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

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

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.

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.

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.