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

NCT04043338 | Unknown Phase 1 FDA Drug

• 1 other identifier: XC130-A10H-CL-101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of Adverse Events

  Adverse Events will be monitored throughout confinement in the clinic and through the 14-day follow-up visit.

  pre-dose through 14 days post-dose

• Changes from baseline in systolic and diastolic blood pressure

  Blood pressure (systolic and diastolic) will be measured pre-dose and throughout the study at the time points specified and compared to baseline.

  pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours

Secondary Outcomes (3)

• Maximum plasma concentration [Cmax] of XC13-A10H

  48 hours

• Area under the curve [AUC] of XC130-A10H

  48 hours

• Time to reach the maximum plasma concentration [Tmax] of XC130-A10H

  48 hours

Study Arms (2)

XC130-A10H

EXPERIMENTAL

XC130-A10H (single dose)

Drug: XC130-A10H

Placebo

PLACEBO COMPARATOR

placebo (single dose)

Drug: Placebo

Interventions

XC130-A10H DRUG

XC130-A10H supplied as a 0.2, 0.4, 0.8, 1.6 or 3.2 mg dose, administered in capsules or tablets

XC130-A10H

Placebo DRUG

Placebo supplied as matching capsules or tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, adult, male or female of non-childbearing potential only, 18-75 years of age.
• Body mass index (BMI) ≥ 18 and ≤ 32.0 kg/m2 at screening.
• Medically healthy with no clinically significant findings from medical history, physical examination, laboratory profiles, vital signs or ECGs.
• Understands the study procedures in the informed consent form (ICF), and is willing and able to comply with the protocol.

You may not qualify if:

• Mental or legal incapacitation or significant emotional problems either present at the time of the screening visit or expected during the conduct of the study.
• History or presence of clinically significant medical, surgical or psychiatric condition or disease.
• History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
• History of clinically significant hypotension.
• History of orthostatic hypotension in the 12 months prior to screening.
• Clinically significant hypertension at screening.
• History or presence of alcoholism within the 2 years prior to dosing or any history of drug abuse.

Sponsors & Collaborators

• Xoc Pharmaceuticals: lead
• Celerion: collaborator

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Robert Fishman, MD

  Xoc Consulting Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: August 2, 2019
• Study Start: August 11, 2019
• Primary Completion: January 30, 2022
• Study Completion: April 30, 2022
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)