Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of XW10508 in healthy volunteers.

Detailed Description
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This is a first-in-human single and multiple ascending oral dose pharmacokinetic and safety study where participants will receive either XW10508 or placebo. Both immediate release and modified release formulations will be assessed. Timed blood samples will be collected to assess the pharmacokinetics after the study drug is ingested by the participants.

Official Title
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A Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: XW10508
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male or female participants who are 18 to 55 years of age, inclusive. Participant is willing and able to provide signed and dated written informed consent to participate prior to admission to the study. Exclusion Criteria: Evidence or history of clinically significant (in the opinion of the investigator) gastrointestinal, hepatic, renal, respiratory (e.g., asthma, COPD), cardiovascular (e.g., hypertension), metabolic, psychiatric, neurological, immunological, or endocrine disorders, or allergic disease including drug allergies, including immediate type hypersensitivity to components of the study drug. A history of childhood asthma that has resolved is acceptable. Use of tobacco- or nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, patches, vaping device, etc.) within 3 months prior to Day -1 and/or positive urine cotinine test at Screening or Day -1. Participant who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition which would confound or interfere with the evaluation of the safety, tolerability, pharmacokinetics or pharmacodynamics of the investigational drug; or is unable to comply with the study 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In this double-blind study, participants will be randomized to XW10508 or placebo.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XW10508<br>XW10508 capsules or tablets | Drug: XW10508<br>* XW10508 capsules or tablets<br>|
| Placebo Comparator: Placebo<br>Placebo capsules or tablets | Other: Placebo<br>* Placebo capsules or tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence, severity, and causality of adverse events (AEs) |  | Up to 12 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) |  | 48 hours | 
| Trough concentration (Cmin) |  | 48 hours | 
| Area under the concentration-time curve (AUC) from 0 to time of last quantifiable concentration |  | 48 hours | 
| AUC from time 0 extrapolated to infinity (AUC0-inf) |  | 48 hours | 
| AUC over the dosing interval (AUCtau) |  | 48 hours | 
| Apparent terminal half-life (t1/2) |  | 48 hours | 
| Cmax and AUC ratios of metabolites to XW10172 |  | 48 hours | 
| Time to reach Cmax (Tmax) |  | 48 hours |