Healthy VolunteersPhase 1NCT06617546
SAD and MAD Study of FTX-101 in Healthy Male Subjects
A Phase 1 study testing FTX-101 in people with Healthy Volunteers, run by Find Therapeutics at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 59 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- FTX-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2024to 17 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
- Use of any prescription drugs in the 28 days or 5 half-lives, whichever is longer, prior to the first study treatment administration, that in the opinion of an investigator would put into question the status of the participant as healthy
- Use of St. John's wort in the 28 days prior to the first study treatment administration
- Positive screening results to HIV Ag/Ab combo, hepatitis B surface Ag or hepatitis C virus tests
- Intake of an investigational product (IP) in the 28 days prior to the first study treatment administration or within 5 times the elimination half-life of the IP, whichever is longer
- Donation of plasma in the 7 days prior to the first study treatment administration
- Donation of 1 unit of blood to American Red Cross or equivalent organization or donation of over 500 mL of blood in the 56 days prior to the first study treatment administration
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212
About this study
Official title: 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
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
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- FTX-101, Placebo
- Keywords
- remyelination, myelin, plexin A1, neuropilin 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FTX-101Drug
Lyophilized powder for subcutaneous injection
PlaceboDrug
Lyophilized powder for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: FTX-101; Drug: 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 Receives: Drug: FTX-101; Drug: 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 Receives: Drug: FTX-101; Drug: 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 Receives: Drug: FTX-101; Drug: 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 Receives: Drug: FTX-101; Drug: 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 Receives: Drug: FTX-101; Drug: 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 Receives: Drug: FTX-101; Drug: 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 Receives: Drug: FTX-101; Drug: 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 Receives: Drug: FTX-101; Drug: 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 Receives: Drug: FTX-101; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events
Frequency of AE will be collected through AE monitoring.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Part A (SAD): Days -1-4, and 15; Part B (MAD:) Days -1-17, and 28
Secondary outcomes (31)
Plasma Cmax
Peak or maximum observed concentration
Measured: 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
Measured: 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)
Measured: 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
Measured: Part A (SAD): Days 1-4
Plasma AUC0-last/∞ (Part A)
Relative percentage of AUC0-last with respect to AUC0-∞
Measured: 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
Measured: Part A (SAD): Days 1-4; Part B (MAD): Day 14-17
Plasma CL/F (Part A)
Apparent clearance, calculated as Dose/AUC0-∞
Measured: Part A (SAD): Days 1-4
Plasma Vz/F (Part A)
Apparent volume of distribution, calculated as Dose/ λZ * AUC0-∞
Measured: Part A (SAD): Days 1-4
Plasma Thalf (Part A)
Terminal elimination half-life, calculated as ln (2)/λZ
Measured: Part A (SAD): Days 1-4
Plasma Cmax/D (Part A)
Dose-normalized Cmax, calculated as Cmax/dose
Measured: Part A (SAD): Days 1-4
Plasma AUC0-last/D (Part A)
Dose-normalized AUC0-last, calculated as AUC0-last/dose
Measured: Part A (SAD): Days 1-4
Plasma AUC0-∞/D (Part A)
Dose normalized AUC 0-∞, calculated as AUC0-∞/dose
Measured: 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
Measured: Part A (SAD): Days 1-4
Plasma AUMC∞ (Part A)
AUMC extrapolated to infinity, based on the last observed concentration
Measured: Part A (SAD): Days 1-4
Plasma AUC0-24 (Part B MAD)
Area under the concentration-time curve over the dosing interval
Measured: Days 1-2
Plasma Ctrough (Part B MAD)
Plasma trough observed concentrations, for Day 11 to Day 13
Measured: Days 11 to 13
Plasma Cmin,ss (Part B MAD)
Minimum observed concentration at steady state
Measured: Days 14-17
Plasma Cmax,ss (Part B MAD)
Peak or maximum observed concentration at steady state
Measured: Days 14-17
Plasma AUC0-τ (Part B MAD)
Area under the concentration-time curve over the dosing interval
Measured: Days 14-17
Plasma Tmax,ss (Part B MAD)
Time of maximum observed concentration at steady state
Measured: Days 14-17
Plasma Thalf (Part B MAD)
Terminal elimination half-life, calculated as ln(2)/λZ
Measured: Days 14-17
Plasma Cav (Part B MAD)
Average steady-state plasma drug concentration calculated as AUC0-τ/τ
Measured: Days 14-17
Plasma Fluctuation (Part B MAD)
The range of steady-state concentrations divided by the average concentration (Day 14 only)
Measured: 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).
Measured: Days 14-17
Plasma Rac(Cmax) (Part B MAD)
Accumulation ratio evaluated by comparing Day 14 Cmax,ss to Day 1 Cmax
Measured: 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
Measured: 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)
Measured: 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)
Measured: Part A (SAD): Days 1-4; Part B (MAD): Days 1, 2, and 14-17
Urine CLR
Renal Clearance (Ae(0-last)/ AUC0-last)
Measured: 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
Measured: 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
Measured: Part B (MAD): Days 14-17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start14 Oct 2024
- Primary completion17 Apr 2025
- Study completion17 Apr 2025
Why it stopped: Study's goals have been achieved based on a preliminary analysis of available pharmacokinetic and safety data, which demonstrate that sufficient information has been obtained.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Find Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin K. Kankam, MD, PhD, MPH, FAPCR, Principal investigator, Altasciences Company Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617546
- Sponsor's protocol ID
- FTX0101
- Status last verified
- Jun 2025
- First submitted
- 25 Sep 2024
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06617546
- Acronym / sponsor ID
- FTX0101
- Conditions
- Healthy Volunteers
- Keywords
- remyelination, myelin, plexin A1, neuropilin 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study's goals have been achieved based on a preliminary analysis of available pharmacokinetic and safety data, which demonstrate that sufficient information has been obtained.
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Find TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 27 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part A (SAD): Cohort A1 | Experimental | Drug: FTX-101, Drug: PlaceboSingle dose (as 1, 2 or 4 SC injection[s]) of FTX-101 or placebo in a 3:1 ratio |
| Part A (SAD): Cohort A2 | Experimental | Drug: FTX-101, Drug: PlaceboSingle dose (as 1, 2 or 4 SC injection[s]) of FTX-101 or placebo in a 3:1 ratio |
| Part A (SAD): Cohort A3 | Experimental | Drug: FTX-101, Drug: PlaceboSingle dose (as 1, 2 or 4 SC injection[s]) of FTX-101 or placebo in a 3:1 ratio |
| Part A (SAD): Cohort A4 | Experimental | Drug: FTX-101, Drug: PlaceboSingle dose (as 1, 2 or 4 SC injection[s]) of FTX-101 or placebo in a 3:1 ratio |
| Part A (SAD): Cohort A5 | Experimental | Drug: FTX-101, Drug: PlaceboSingle dose (as 1, 2 or 4 SC injection[s]) of FTX-101 or placebo in a 3:1 ratio |
| Part A (SAD): Cohort A6 | Experimental | Drug: FTX-101, Drug: PlaceboOptional 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 |
| Part B (MAD): Cohort B1 | Experimental | Drug: FTX-101, Drug: PlaceboOnce daily dose (as 1 or 2 SC injection[s]) of FTX-101 or placebo for 14 days in a 3:1 ratio |
| Part B (MAD): Cohort B2 | Experimental | Drug: FTX-101, Drug: PlaceboOnce daily dose (as 1 or 2 SC injection[s]) of FTX-101 or placebo for 14 days in a 3:1 ratio |
| Part B (MAD): Cohort B3 | Experimental | Drug: FTX-101, Drug: PlaceboOnce daily dose (as 1 or 2 SC injection[s]) of FTX-101 or placebo for 14 days in a 3:1 ratio |
| Part B (MAD): Cohort B4 | Experimental | Drug: FTX-101, Drug: PlaceboOptional 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 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FTX-101Lyophilized powder for subcutaneous injection | Drug | Part A (SAD): Cohort A1, Part A (SAD): Cohort A2, Part A (SAD): Cohort A3, Part A (SAD): Cohort A4, Part A (SAD): Cohort A5, Part A (SAD): Cohort A6, Part B (MAD): Cohort B1, Part B (MAD): Cohort B2, Part B (MAD): Cohort B3, Part B (MAD): Cohort B4 |
| PlaceboLyophilized powder for subcutaneous injection | Drug | Part A (SAD): Cohort A1, Part A (SAD): Cohort A2, Part A (SAD): Cohort A3, Part A (SAD): Cohort A4, Part A (SAD): Cohort A5, Part A (SAD): Cohort A6, Part B (MAD): Cohort B1, Part B (MAD): Cohort B2, Part B (MAD): Cohort B3, Part B (MAD): Cohort B4 |
Primary outcome
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.
31 secondary outcomes
Plasma Cmax
Time frame: Part A (SAD): Days 1-4; Part B (MAD): Days 1-2
Plasma Tmax
Time frame: Part A (SAD): Days 1-4; Part B (MAD): Days 1-2
Plasma AUC0-last
Time frame: Part A (SAD): Days 1-4; Part B (MAD): Days 1-2
Plasma AUC0-∞ (Part A)
Time frame: Part A (SAD): Days 1-4
Plasma AUC0-last/∞ (Part A)
Time frame: Part A (SAD): Days 1-4
Plasma λz
Time frame: Part A (SAD): Days 1-4; Part B (MAD): Day 14-17
Plasma CL/F (Part A)
Time frame: Part A (SAD): Days 1-4
Plasma Vz/F (Part A)
Time frame: Part A (SAD): Days 1-4
Plasma Thalf (Part A)
Time frame: Part A (SAD): Days 1-4
Plasma Cmax/D (Part A)
Time frame: Part A (SAD): Days 1-4
Plasma AUC0-last/D (Part A)
Time frame: Part A (SAD): Days 1-4
Plasma AUC0-∞/D (Part A)
Time frame: Part A (SAD): Days 1-4
Plasma AUMC0-last (Part A)
Time frame: Part A (SAD): Days 1-4
Plasma AUMC∞ (Part A)
Time frame: Part A (SAD): Days 1-4
Plasma AUC0-24 (Part B MAD)
Time frame: Days 1-2
Plasma Ctrough (Part B MAD)
Time frame: Days 11 to 13
Plasma Cmin,ss (Part B MAD)
Time frame: Days 14-17
Plasma Cmax,ss (Part B MAD)
Time frame: Days 14-17
Plasma AUC0-τ (Part B MAD)
Time frame: Days 14-17
Plasma Tmax,ss (Part B MAD)
Time frame: Days 14-17
Plasma Thalf (Part B MAD)
Time frame: Days 14-17
Plasma Cav (Part B MAD)
Time frame: Days 14-17
Plasma Fluctuation (Part B MAD)
Time frame: Days 14-17
Plasma Swing (Part B MAD)
Time frame: Days 14-17
Plasma Rac(Cmax) (Part B MAD)
Time frame: Days 1-2, and 14-17
Plasma Rac(AUC) (Part B MAD)
Time frame: Days 1-2, and 14-17
Urine Ae(0-last)
Time frame: Part A (SAD): Days 1-4; Part B (MAD): Days 1, 2, and 14-17
Urine fe
Time frame: Part A (SAD): Days 1-4; Part B (MAD): Days 1, 2, and 14-17
Urine CLR
Time frame: Part A (SAD): Days 1-4; Part B (MAD): Days 1, 2, and 14-17
Plasma CLss/F (Part B MAD)
Time frame: Part B (MAD): Days 14-17
Plasma Vz/F (Part B MAD)
Time frame: Part B (MAD): Days 14-17
Results and safety
The study was stopped early (reason given: Study's goals have been achieved based on a preliminary analysis of available pharmacokinetic and safety data, which demonstrate that sufficient information has been obtained.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin K. Kankam, MD, PhD, MPH, FAPCR principal investigator
Altasciences Company Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FTX-101 in people with Healthy Volunteers, run by Find Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study's goals have been achieved based on a preliminary analysis of available pharmacokinetic and safety data, which demonstrate that sufficient information has been obtained.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adverse events (time frame: Part A (SAD): Days -1-15; Part B (MAD): Days -1-28). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.