NCT04043338

Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study Investigating the Safety, Tolerability, and Pharmacokinetics of XC130-A10H in Healthy Adult Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Xoc Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Safety, tolerability, and pharmacokinetics will be assessed throughout the study. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort.

Detailed description

This is a randomized, double-blind, placebo-controlled, parallel group SAD study conducted at one study center. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort. Safety (i.e., adverse events \[AEs\], physical examinations, pulse oximetry, vital signs, orthostatic vital signs, 12-lead electrocardiograms (ECGs), clinical laboratory tests, Columbia suicide severity rating scale \[C-SSRS\], and Mini-Mental State Examination \[MMSE\]) will be assessed throughout the study. Blood samples will be collected through 48 hours post-dose for the PK assessment of XC130-A10H and the metabolites.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	XC130-A10H	XC130-A10H supplied as a 0.2, 0.4, 0.8, 1.6 or 3.2 mg dose, administered in capsules or tablets
DRUG	Placebo	Placebo supplied as matching capsules or tablets

Timeline

• Start date: 2019-08-11
• Primary completion: 2022-01-30
• Completion: 2022-04-30
• First posted: 2019-08-02
• Last updated: 2021-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study