Clinical Trials/NCT06617546

NCT06617546

Terminated

Phase 1

A Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study to Assess Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Ascending Doses of FTX-101 After Subcutaneous Injection of FTX-101 in Healthy Male Subjects

Find Therapeutics1 site in 1 country49 target enrollmentOctober 14, 2024

ConditionsHealthy Volunteers

InterventionsFTX-101 Placebo

DrugsPlacebo FTX-101

Overview

Phase: Phase 1
Intervention: FTX-101
Conditions: Healthy Volunteers
Sponsor: Find Therapeutics
Enrollment: 49
Locations: 1
Primary Endpoint: Frequency of adverse events
Status: Terminated
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 1, first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled study in healthy male subjects. The study will include the following 2 parts:

Part A: Single Ascending Dose (SAD) in healthy male subjects
Part B: Multiple Ascending Dose (MAD) in healthy male subjects

Detailed Description

Study Rationale: FTX-101 is a first-in-class, synthetic peptide with a novel mechanism of action designed to promote the self-repair of myelin. FTX-101 is a highly selective modulator of the PlexinA1/Neuropilin 1 receptor system and displays no significant activity on any other target. FTX-101 interferes with the heterodimerization of the coreceptor system and, ultimately, with the activation of second messenger signaling pathways shown to inhibit both the differentiation and migration of oligodendrocyte precursor cells (OPCs) and oligodendrocytes (OLs). Through this mechanism, FTX-101 disinhibits both the differentiation of OPCs to OLs and migration of OPCs into lesions, favorably promoting the remyelination process. The study is designed to evaluate the safety, tolerability and pharmacokinetic profile of single ascending doses and multiple ascending doses of FTX-101 subcutaneous injection in healthy male subjects. The study will characterize the pharmacokinetics of FTX-101 following SAD and MAD SC injection of FTX-101. The study will also evaluate the immunogenic potential of FTX-101 and will also explore the relationship between FTX-101 concentration and the change from baseline corrected QT interval. Detailed Description: This is a Phase 1, first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled study in healthy male subjects. The study will include the following 2 parts: * Part A: SAD in healthy male subjects * Part B: MAD in healthy male subjects Part A - SAD: Part A consists of 5 planned cohorts (A1 to A5) of 8 healthy adult male subjects each. An additional SAD intermediate (lower) or equivalent dose cohort (A6) of 8 male subjects may be added at the discretion of the Sponsor. In each cohort, subjects will be randomized to receive a single subcutaneous (SC) dose (as 1, 2 or 4 injection\[s\]) of either FTX-101 or placebo in a 3:1 (FTX-101: placebo) ratio to have a total of 6 subjects receiving FTX-101 and 2 subjects receiving placebo. Part B - MAD: Part B consists of 3 planned cohorts (B1 to B3) of 8 healthy adult male subjects each. An additional MAD cohort (B4) of 8 male subjects may be added at the discretion of the Sponsor depending on emerging safety and plasma PK data from the previous cohort(s). The proposed dosing regimen (dose level and frequency) for the first cohort (B1) in Part B (MAD) will be based on available safety, tolerability, and PK data from Part A (SAD). The dosing regimens for each subsequent cohort in Part B will be determined based on the available blinded safety, tolerability, and PK data from Part A and any previous cohorts in Part B. In each cohort, subjects will be randomized to receive multiple SC doses of either FTX-101 or placebo in a 3:1 (FTX-101: placebo) ratio to have a total of 6 subjects receiving FTX-101 and 2 subjects receiving placebo.

Registry

clinicaltrials.gov

Start Date

October 14, 2024

End Date

April 17, 2025

Last Updated

10 months ago

Study Type

Interventional

Study Design

Sequential

Sex

Male

Investigators

Sponsor

Find Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willingness to comply with all study procedures and availability for the duration of the study
•Healthy adult male
•Aged at least 18 years but not older than 59 years
•Body mass index (BMI) within 18.5 kg/m\^2 to 32.0 kg/m\^2, inclusively
•Non- or ex-smoker
•Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG.

Exclusion Criteria

•Supine or semi-supine pulse rate less than 45 beats per minute (bpm) or more than 100 bpm
•Supine or semi-supine blood pressure below 90/50 mmHg
•Supine or semi-supine blood pressure higher than 150/95 mmHg
•History of significant hypersensitivity to FTX-101 or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
•Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability
•History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
•Showing suicidal tendency from 6 months prior to screening
•Presence of out-of-range cardiac intervals at screening defined as:
•PR \< 110 msec, PR \> 200 msec
•QRS \< 60 msec, QRS \>110 msec)

Intervention: Placebo

Outcomes

Primary Outcomes

Frequency of adverse events

Time Frame: Part A (SAD): Days -1-15; Part B (MAD): Days -1-28

Frequency of AE will be collected through AE monitoring.

Severity of adverse events

Time Frame: Part A (SAD): Days -1-15; Part B (MAD): Days -1-28

Severity of AE will be collected through AE monitoring. AEs will be graded per the current National Cancer Institute's Common Terminology Criteria for Adverse Events.

Number of patients with a change in general biochemistry, hematology, coagulation and urinalysis clinical laboratory parameters

Time Frame: Part A (SAD): Days -1, 4 and 15; Part B (MAD): Days -1, 5, 9, 13, 17, 28

Frequency of abnormal general biochemistry, hematology, coagulation, and urinalysis clinical laboratory values.

Number of patients with a change in vital signs

Time Frame: Part A (SAD): Days -1-4 and 15; Part B (MAD): Days -1-17 and 28

Frequency of abnormal vital sign measurements.

Number of patients with a change in 12-lead safety electrocardiogram (ECG)

Time Frame: Part A (SAD): Days -1-2, and 15; Part B (MAD): Days -1, 1, 3, 5, 7, 9, 11, 14, 28

Frequency of abnormal 12-lead ECG parameters including PR, RR, QRS, QT and QTcF.

Number of patients with a change in physical examination findings

Time Frame: Part A (SAD): Days -1-4, and 15; Part B (MAD): Days -1-17, 28

Frequency of abnormal physical examination findings.

Number of patients with a change in neurological examination findings

Time Frame: Part A (SAD): Days 1, 2, 4, and 15; Part B (MAD): Days 1, 2, 5, 9, 14, 15, 17, and 29

Frequency of abnormal neurological examination findings.

Frequency of injection site reactions

Time Frame: Part A (SAD): Days 1, 2, and 15; Part B (MAD): Days 1-14, and 28

Evaluation of pain, tenderness, erythema/redness, swelling/induration or itching at the injection site will be rated mild (Grade 1), moderate (Grade 2), Severe (Grade 3), or potentially life-threatening (Grade 4)

Change in Columbia Suicide Severity Rating Scale (C-SSRS) score

Time Frame: Part A (SAD): Days -1-4, and 15; Part B (MAD:) Days -1-17, and 28

Frequency of positive results for suicidality. The C-SSRS is a questionnaire designed for the assessment of suicidal ideation and behavior in adolescents and adults.