NCT06617546

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Oct 2024

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

October 14, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

September 25, 2024

Last Update Submit

June 13, 2025

Conditions

Healthy Volunteers

Keywords

remyelinationmyelinplexin A1neuropilin 1

Outcome Measures

Primary Outcomes (9)

  • Frequency of adverse events

    Frequency of AE will be collected through AE monitoring.

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

  • Severity of adverse events

    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.

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

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

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

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

  • Number of patients with a change in vital signs

    Frequency of abnormal vital sign measurements.

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

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

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

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

  • Number of patients with a change in physical examination findings

    Frequency of abnormal physical examination findings.

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

  • Number of patients with a change in neurological examination findings

    Frequency of abnormal neurological examination findings.

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

  • Frequency of injection site reactions

    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)

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

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

    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.

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

Secondary Outcomes (31)

  • Plasma Cmax

    Part A (SAD): Days 1-4; Part B (MAD): Days 1-2

  • Plasma Tmax

    Part A (SAD): Days 1-4; Part B (MAD): Days 1-2

  • Plasma AUC0-last

    Part A (SAD): Days 1-4; Part B (MAD): Days 1-2

  • Plasma AUC0-∞ (Part A)

    Part A (SAD): Days 1-4

  • Plasma AUC0-last/∞ (Part A)

    Part A (SAD): Days 1-4

  • +26 more secondary outcomes

Study Arms (10)

Part A (SAD): Cohort A1

EXPERIMENTAL

Single dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio

Drug: FTX-101Drug: Placebo

Part A (SAD): Cohort A2

EXPERIMENTAL

Single dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio

Drug: FTX-101Drug: Placebo

Part A (SAD): Cohort A3

EXPERIMENTAL

Single dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio

Drug: FTX-101Drug: Placebo

Part A (SAD): Cohort A4

EXPERIMENTAL

Single dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio

Drug: FTX-101Drug: Placebo

Part A (SAD): Cohort A5

EXPERIMENTAL

Single dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio

Drug: FTX-101Drug: Placebo

Part A (SAD): Cohort A6

EXPERIMENTAL

Optional cohort to receive additional single ascending intermediate (lower) or equivalent dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio

Drug: FTX-101Drug: Placebo

Part B (MAD): Cohort B1

EXPERIMENTAL

Once daily dose (as 1 or 2 SC injection\[s\]) of FTX-101 or placebo for 14 days in a 3:1 ratio

Drug: FTX-101Drug: Placebo

Part B (MAD): Cohort B2

EXPERIMENTAL

Once daily dose (as 1 or 2 SC injection\[s\]) of FTX-101 or placebo for 14 days in a 3:1 ratio

Drug: FTX-101Drug: Placebo

Part B (MAD): Cohort B3

EXPERIMENTAL

Once daily dose (as 1 or 2 SC injection\[s\]) of FTX-101 or placebo for 14 days in a 3:1 ratio

Drug: FTX-101Drug: Placebo

Part B (MAD): Cohort B4

EXPERIMENTAL

Optional cohort to receive once daily dose (as 1 or 2 SC injection\[s\]) of FTX-101 or placebo for 14 days in a 3:1 ratio

Drug: FTX-101Drug: Placebo

Interventions

FTX-101DRUG

Lyophilized powder for subcutaneous injection

Part A (SAD): Cohort A1Part A (SAD): Cohort A2Part A (SAD): Cohort A3Part A (SAD): Cohort A4Part A (SAD): Cohort A5Part A (SAD): Cohort A6Part B (MAD): Cohort B1Part B (MAD): Cohort B2Part B (MAD): Cohort B3Part B (MAD): Cohort B4
PlaceboDRUG

Lyophilized powder for subcutaneous injection

Part A (SAD): Cohort A1Part A (SAD): Cohort A2Part A (SAD): Cohort A3Part A (SAD): Cohort A4Part A (SAD): Cohort A5Part A (SAD): Cohort A6Part B (MAD): Cohort B1Part B (MAD): Cohort B2Part B (MAD): Cohort B3Part B (MAD): Cohort B4

Eligibility Criteria

Age18 Years - 59 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • QT Interval Corrected for Heart Rate using Fridericia's Correction Formula (QTcF): • \> 450 msec
  • History of additional risk factors for torsade's de pointes
  • Use of concomitant medications that prolong the QT/ corrected QT (QTc) interval
  • Current use (in the last 6 months) of alcohol (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
  • Any history of substance or alcohol use disorder within the past 2 years and/or current maintenance therapy (within the past 2 years) for treatment of substance use disorder
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altasciences Clinical Kansas, Inc.

Overland Park, Kansas, 66212, United States

Location

Study Officials

  • Martin K. Kankam, MD, PhD, MPH, FAPCR

    Altasciences Clinical Kansas, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2024

First Posted

September 27, 2024

Study Start

October 14, 2024

Primary Completion

April 17, 2025

Study Completion

April 17, 2025

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)