|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
27 September 2021 |
|
Main ID: |
NCT04043338 |
|
Date of registration:
|
24/07/2019 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects
|
|
Scientific title:
|
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 |
|
Date of first enrolment:
|
August 11, 2019 |
|
Target sample size:
|
56 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT04043338 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Robert Fishman, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Xoc Consulting Chief Medical Officer |
| | |
|
Key inclusion & exclusion criteria
|
Major Inclusion Criteria:
- 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.
Major Exclusion Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Parkinson's Disease
|
|
Intervention(s)
|
|
Drug: Placebo
|
|
Drug: XC130-A10H
|
|
Primary Outcome(s)
|
|
Changes from baseline in systolic and diastolic blood pressure
[Time Frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours]
|
|
Incidence and severity of Adverse Events
[Time Frame: pre-dose through 14 days post-dose]
|
|
Secondary Outcome(s)
|
|
Maximum plasma concentration [Cmax] of XC13-A10H
[Time Frame: 48 hours]
|
|
Time to reach the maximum plasma concentration [Tmax] of XC130-A10H
[Time Frame: 48 hours]
|
|
Area under the curve [AUC] of XC130-A10H
[Time Frame: 48 hours]
|
|
Secondary ID(s)
|
|
XC130-A10H-CL-101
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|