A Phase 1 interventional study of FTX-101 and Placebo in Healthy Volunteers, sponsored by Find Therapeutics. Terminated at 1 site in United States. Open to male participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-18.
Sponsored by Find Therapeutics · Phase 1, Interventional, and Basic science
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:
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:
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.
This is the only study on the registry with Find Therapeutics as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Presence of out-of-range cardiac intervals at screening defined as:
Single dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio
Drug: FTX-101 · Drug: Placebo
Single dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio
Drug: FTX-101 · Drug: Placebo
Single dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio
Drug: FTX-101 · Drug: Placebo
Single dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio
Drug: FTX-101 · Drug: Placebo
Single dose (as 1, 2 or 4 SC injection\[s\]) of FTX-101 or placebo in a 3:1 ratio
Drug: FTX-101 · Drug: Placebo
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-101 · Drug: Placebo
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-101 · Drug: Placebo
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-101 · Drug: Placebo
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-101 · Drug: Placebo
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-101 · Drug: Placebo
Lyophilized powder for subcutaneous injection
Lyophilized powder for subcutaneous injection
Frequency of adverse events
Frequency of AE will be collected through AE monitoring.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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 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)
Time frame: 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.
Time frame: Part A (SAD): Days -1-4, and 15; Part B (MAD:) Days -1-17, and 28
Plasma Cmax
Peak or maximum observed concentration
Time frame: Part A (SAD): Days 1-4; Part B (MAD): Days 1-2
Plasma Tmax
Time of maximum observed concentration. If the maximum observed concentration is not unique, then the first maximum is used
Time frame: Part A (SAD): Days 1-4; Part B (MAD): Days 1-2
Plasma AUC0-last
Area under the concentration-time curve from dosing to the time of last quantifiable concentration (Tlast)
Time frame: Part A (SAD): Days 1-4; Part B (MAD): Days 1-2
Plasma AUC0-∞ (Part A)
Area under the concentration time curve extrapolated to infinity, calculated as AUClast + Clast/λZ, where Clast is the last quantifiable concentration at time Tlast
Time frame: Part A (SAD): Days 1-4
Plasma AUC0-last/∞ (Part A)
Relative percentage of AUC0-last with respect to AUC0-∞
Time frame: Part A (SAD): Days 1-4
Plasma λz
Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus the time curve
Time frame: Part A (SAD): Days 1-4; Part B (MAD): Day 14-17
Plasma CL/F (Part A)
Apparent clearance, calculated as Dose/AUC0-∞
Time frame: Part A (SAD): Days 1-4
Plasma Vz/F (Part A)
Apparent volume of distribution, calculated as Dose/ λZ \* AUC0-∞
Time frame: Part A (SAD): Days 1-4
Plasma Thalf (Part A)
Terminal elimination half-life, calculated as ln (2)/λZ
Time frame: Part A (SAD): Days 1-4
Plasma Cmax/D (Part A)
Dose-normalized Cmax, calculated as Cmax/dose
Time frame: Part A (SAD): Days 1-4
Plasma AUC0-last/D (Part A)
Dose-normalized AUC0-last, calculated as AUC0-last/dose
Time frame: Part A (SAD): Days 1-4
Plasma AUC0-∞/D (Part A)
Dose normalized AUC 0-∞, calculated as AUC0-∞/dose
Time frame: Part A (SAD): Days 1-4
Plasma AUMC0-last (Part A)
Area under the moment curve (AUMC) from the time of dosing to the last measurable (positive) concentration
Time frame: Part A (SAD): Days 1-4
Plasma AUMC∞ (Part A)
AUMC extrapolated to infinity, based on the last observed concentration
Time frame: Part A (SAD): Days 1-4
Plasma AUC0-24 (Part B MAD)
Area under the concentration-time curve over the dosing interval
Time frame: Days 1-2
Plasma Ctrough (Part B MAD)
Plasma trough observed concentrations, for Day 11 to Day 13
Time frame: Days 11 to 13
Plasma Cmin,ss (Part B MAD)
Minimum observed concentration at steady state
Time frame: Days 14-17
Plasma Cmax,ss (Part B MAD)
Peak or maximum observed concentration at steady state
Time frame: Days 14-17
Plasma AUC0-τ (Part B MAD)
Area under the concentration-time curve over the dosing interval
Time frame: Days 14-17
Plasma Tmax,ss (Part B MAD)
Time of maximum observed concentration at steady state
Time frame: Days 14-17
Plasma Thalf (Part B MAD)
Terminal elimination half-life, calculated as ln(2)/λZ
Time frame: Days 14-17
Plasma Cav (Part B MAD)
Average steady-state plasma drug concentration calculated as AUC0-τ/τ
Time frame: Days 14-17
Plasma Fluctuation (Part B MAD)
The range of steady-state concentrations divided by the average concentration (Day 14 only)
Time frame: Days 14-17
Plasma Swing (Part B MAD)
Degree of swing over a dosing interval, after the last dose of a multiple-dose regimen expressed as a percentage. Calculated as 100\*(Cmax-Cmin/Cmin).
Time frame: Days 14-17
Plasma Rac(Cmax) (Part B MAD)
Accumulation ratio evaluated by comparing Day 14 Cmax,ss to Day 1 Cmax
Time frame: Days 1-2, and 14-17
Plasma Rac(AUC) (Part B MAD)
Accumulation ratio evaluated by comparing Day 14 AUC0-τ to Day 1 AUC0-24
Time frame: Days 1-2, and 14-17
Urine Ae(0-last)
Cumulative amount excreted over all time intervals (0 to Tlast), calculated as the sum of all amounts excreted from each interval (t1-t2)
Time frame: Part A (SAD): Days 1-4; Part B (MAD): Days 1, 2, and 14-17
Urine fe
Fraction of unchanged drug excreted in urine during the time interval (expressed in %, calculated)
Time frame: Part A (SAD): Days 1-4; Part B (MAD): Days 1, 2, and 14-17
Urine CLR
Renal Clearance (Ae(0-last)/ AUC0-last)
Time frame: Part A (SAD): Days 1-4; Part B (MAD): Days 1, 2, and 14-17
Plasma CLss/F (Part B MAD)
Apparent clearance at steady state, calculated as Dose/AUC0-τ
Time frame: Part B (MAD): Days 14-17
Plasma Vz/F (Part B MAD)
Apparent volume of distribution at steady state, calculated as Dose/ λZ \* AUC0-τ
Time frame: Part B (MAD): Days 14-17
Plan to share: No
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