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

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ClinicalTrials.gov Identifier: NCT05279755

Recruitment Status : Recruiting

First Posted : March 15, 2022

Last Update Posted : March 15, 2022

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Worldwide Clinical Trials

Information provided by (Responsible Party):

ProJenX

Tracking Information

First Submitted Date ^ICMJE

February 23, 2022

First Posted Date ^ICMJE

March 15, 2022

Last Update Posted Date

March 15, 2022

Actual Study Start Date ^ICMJE

February 26, 2022

Estimated Primary Completion Date

May 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Incidence and severity of adverse events (AEs) [ Time Frame: Up to 42 days ]
Incidence of significant clinical laboratory test abnormalities [ Time Frame: Up to 42 days ]
Incidence of significant vital signs abnormalities [ Time Frame: Up to 42 days ]
Incidence of significant electrocardiogram (ECG) abnormalities [ Time Frame: Up to 42 days ]
Incidence of significant physical, neurological, and/or ophthalmic examination abnormalities [ Time Frame: Up to 42 days ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Maximum concentration (Cmax) of prosetin in plasma [ Time Frame: Up to 42 days ]
Maximum concentration (Cmax) of prosetin in cerebrospinal fluid (CSF) [ Time Frame: Up to 42 days ]
Area under the concentration versus time curve (AUC) of prosetin in plasma [ Time Frame: Up to 42 days ]
Area under the concentration versus time curve (AUC) of prosetin in CSF [ Time Frame: Up to 42 days ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Amyotrophic Lateral Sclerosis

Intervention ^ICMJE

Drug: prosetin
oral solution
Drug: placebo
oral solution

Study Arms ^ICMJE

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

Intervention: Drug: prosetin
Placebo Comparator: Placebo
Part A: single-ascending dose; Part B: multiple doses (7 days)

Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

July 2022

Estimated Primary Completion Date

May 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 65 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact: ProJenX Clinical Trials

(917) 423-6476

trials@projenx.com

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT05279755

Other Study ID Numbers ^ICMJE

5027513

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

ProJenX

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

ProJenX

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Worldwide Clinical Trials

Investigators ^ICMJE

Not Provided

PRS Account

ProJenX

Verification Date

March 2022

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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