Randomized, Double-Blind, Placebo-Controlled, MAD Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023

NCT ID: NCT03542435

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-26
• Study Completion Date: 2018-09-10

Brief Summary

This is a randomized, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SXC-2023

Dose Escalation

Group Type: EXPERIMENTAL

SXC-2023

Intervention Type: DRUG

Oral capsule

Placebo

Dose Escalation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

SXC-2023

Oral capsule

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy, adult, male or female, 18 55 years of age, inclusive, at screening.

2. Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dose and throughout the study.

3. BMI ≥ 18.0 and ≤ 32.0 kg/m2 at screening.

4. Medically healthy with no clinically significant screening results.

5. For a female of childbearing potential: either be sexually inactive (abstinent as a life style) for 28 days prior to the first dosing and throughout the study or be using acceptable birth control methods:

6. Female of non childbearing potential: must have undergone sterilization procedures, at least 6 months prior to the first dose

7. Non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug/placebo.

8. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria

1. Subject is mentally or legally incapacitated

2. History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.

3. History or presence of alcoholism or drug abuse within the past 2 years

4. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.

5. Females with a positive pregnancy test or is lactating.

6. Positive urine cotinine at screening.

7. Positive urine drug or alcohol results at screening

8. Any significant finding on the Columbia Suicidal Severity Rating Scale (C-SSRS)

9. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).

10. Unable to refrain from or anticipates the use of any drug (e.g. prescription, recreational, etc.)

11. Donation of blood or significant blood loss within 56 days prior to the first dose.

12. Plasma donation within 7 days prior to the first dose.

13. Participation in another clinical study within 30 days prior to the first dose.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Promentis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tricia Cotter

Role: STUDY_DIRECTOR

Promentis Pharmaceuticals, Inc.

Locations

Celerion

Tempe, Arizona, United States

Countries

United States

Other Identifiers

PRO-104

Identifier Type: -

Identifier Source: org_study_id