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A Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Prosetin in Healthy Volunteers (PRO-101)

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

prosetin

placebo

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria:

Adults between 18 and 65 years of age, inclusive
BMI within 18.0 to 32.0 kg/m2, inclusive
In good health, in the opinion of the Investigator, as determined by a physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments
Females of childbearing potential must agree to an approved method of contraception

Key Exclusion Criteria:

History or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, neurological, or psychiatric disorder
Any episodes of vertigo in the previous 12 months prior to screening or any medical history of seizures
Active autoimmune conditions such as systemic lupus erythematosus
A diagnosis of cancer or evidence of continued disease within five years before screening

Sites / Locations

Worldwide Clinical Trials Early Phase ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prosetin

Placebo

Arm Description

Part A: single-ascending dose; Part B: multiple doses (7 days)

Outcomes

Primary Outcome Measures

Incidence and severity of adverse events (AEs)

Incidence of significant clinical laboratory test abnormalities

Incidence of significant vital signs abnormalities

Incidence of significant electrocardiogram (ECG) abnormalities

Incidence of significant physical, neurological, and/or ophthalmic examination abnormalities

Secondary Outcome Measures

Maximum concentration (Cmax) of prosetin in plasma

Maximum concentration (Cmax) of prosetin in cerebrospinal fluid (CSF)

Area under the concentration versus time curve (AUC) of prosetin in plasma

Area under the concentration versus time curve (AUC) of prosetin in CSF

Full Information

NCT ID

NCT05279755

First Posted

February 23, 2022

Last Updated

March 6, 2022

Sponsor

ProJenX

Collaborators

Worldwide Clinical Trials

1. Study Identification

Unique Protocol Identification Number

NCT05279755

Brief Title

A Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Prosetin in Healthy Volunteers

Acronym

PRO-101

Official Title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety and Pharmacokinetics of Single Ascending and Multiple Doses of Prosetin in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

February 26, 2022 (Actual)

Primary Completion Date

May 2022 (Anticipated)

Study Completion Date

July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ProJenX

Collaborators

Worldwide Clinical Trials

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This trial is a Phase 1a/1b, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of prosetin administered to healthy adult subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prosetin

Arm Type

Experimental

Arm Description

Part A: single-ascending dose; Part B: multiple doses (7 days)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Part A: single-ascending dose; Part B: multiple doses (7 days)

Intervention Type

Drug

Intervention Name(s)

prosetin

Intervention Description

oral solution

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

oral solution

Primary Outcome Measure Information:

Title

Incidence and severity of adverse events (AEs)

Time Frame

Up to 42 days

Title

Incidence of significant clinical laboratory test abnormalities

Time Frame

Up to 42 days

Title

Incidence of significant vital signs abnormalities

Time Frame

Up to 42 days

Title

Incidence of significant electrocardiogram (ECG) abnormalities

Time Frame

Up to 42 days

Title

Incidence of significant physical, neurological, and/or ophthalmic examination abnormalities

Time Frame

Up to 42 days

Secondary Outcome Measure Information:

Title

Maximum concentration (Cmax) of prosetin in plasma

Time Frame

Up to 42 days

Title

Maximum concentration (Cmax) of prosetin in cerebrospinal fluid (CSF)

Time Frame

Up to 42 days

Title

Area under the concentration versus time curve (AUC) of prosetin in plasma

Time Frame

Up to 42 days

Title

Area under the concentration versus time curve (AUC) of prosetin in CSF

Time Frame

Up to 42 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Adults between 18 and 65 years of age, inclusive BMI within 18.0 to 32.0 kg/m2, inclusive In good health, in the opinion of the Investigator, as determined by a physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments Females of childbearing potential must agree to an approved method of contraception Key Exclusion Criteria: History or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, neurological, or psychiatric disorder Any episodes of vertigo in the previous 12 months prior to screening or any medical history of seizures Active autoimmune conditions such as systemic lupus erythematosus A diagnosis of cancer or evidence of continued disease within five years before screening

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ProJenX Clinical Trials

Phone

(917) 423-6476

trials@projenx.com

Facility Information:

Facility Name

Worldwide Clinical Trials Early Phase Services

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ingela Danielsson, MD, PhD, MBA

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Prosetin in Healthy Volunteers

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