Androgenetic AlopeciaPhase 1NCT04502901
the Safety, Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose Ascending
A Phase 1 study testing KX0826 in people with Androgenetic Alopecia, run by Suzhou Kintor Pharmaceutical Inc, at 1 site in United States.
Trial summary
The study is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and PK of KX-826 following topical multiple ascending dose administration. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- KX0826
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2020to 15 Jan 2021
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are capable of giving informed consent and complying with study procedures;
- Are males between the ages of 18 and 60 years, inclusive;
- Have a clinical diagnosis of androgenetic alopecia;
- Considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs (systolic blood pressure ≥90 and ≤150 mmHg, diastolic blood pressure ≥50 and ≤95 mmHg and pulse rate ≥45 and ≤100 bpm; one repeat allowed to confirm out of range values);
- Have normal renal and hepatic function as determined by the screening laboratory results;
- Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 months before screening;
- Body mass index (BMI) of 19.0 to 35.0 kg/m2 inclusive and body weight not less than 50 kg;
- Willing and able to adhere to study restrictions and to be confined at the CRU
Who cannot join
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
- Any visible skin disease, damage or condition at the application site which, in the opinion of the investigator, could compromise subject safety and/or interfere with the evaluation of the test site reaction;
- Subject has any dermatological disorders of the scalp;
- Subject has a history of hair transplants, hair weaves;
- Subject has hypersensitivity to previously prescribed minoxidil or finasteride;
- Known or suspected malignancy;
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- Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody;
- A hospital admission or major surgery within 30 days prior to screening;
- Participation in any other investigational drug trial within 30 days prior to screening;
- A history of prescription drug abuse, or illicit drug use within 6 months prior to screening;
- A history of alcohol abuse according to medical history within 6 months prior to screening;
- A positive screen for alcohol or drugs of abuse;
- Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to screening;
- Use of prescription or over-the-counter (OTC) medications, and herbal (including St John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing (Note: Use of acetaminophen at <3g/day is permitted until 24 hours prior to dosing);
- An unwillingness of male participants to use appropriate contraceptive measures if engaging in sexual intercourse with a female partner of childbearing potential. Appropriate measures include use of a condom and spermicide and, for female partners, use of an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, progesterone subdermal implants, or a tubal ligation.
Trial locations and contacts
1 site in 1 country.
United States1 site
inVentiv Health Clinical Research Services LLC
Miami, Florida, 33136
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study in Healthy Male Subjects With Androgenetic Alopecia to Evaluate the Safety, Tolerability and PK of KX-826 Following Topical Multiple Dose Ascending
The study is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and PK of KX-826 following topical multiple ascending dose administration.
Read the detailed description
KX-826 topical solution will be applied to the scalp of healthy male subjects with androgenetic alopecia.
A total of 40 subjects will be evaluated with 32 subjects randomized to receive active drug and 8 subjects randomized to receive placebo in a double-blind fashion (10 subjects in each dose cohort with 8 subjects randomized to receive active drug and 2 subjects randomized to receive placebo for a total of 4 dose cohorts).
Cohort Dose of KX-826 Subjects
- 2.5 mg QD for 14 days 10 (8 active + 2 placebo)
- 5 mg QD for 14 days 10 (8 active + 2 placebo)
- 10 mg QD for 14 days 10 (8 active + 2 placebo)
- 20 mg QD for 14 days 10 (8 active + 2 placebo)
Dose escalation will not occur until review of the multiple dose safety from the previous dose cohort is completed. Safety assessments will include monitoring of AEs, vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead ECGs, skin irritation assessments and physical examination findings.
- Conditions
- Androgenetic Alopecia
- Being tested
- KX0826, Placebo
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KX0826Drug
Also called Pyrilutamide, KX-826
investigational AR antagonist
PlaceboOther
Placebo of KX-826
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group -KX0826 | Experimental | KX0826 is tropically applied to the scalp of healthy male subjects once a day for 14 days. The applied dosage cohorts are 2.5mg, 5mg, 10mg and 20mg. Receives: Drug: KX0826 |
| Control Group- Placebo | Placebo comparator | Placebo is tropically applied to the scalp of healthy male subjects once a day for 14 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessment, vital sign, ECG and clinical lab assessments
skin irritation assessment will be performed during the treatment period. The dermal response score will be based on a visual irritation scale (0-7) that rates the degree of erythema, edema and other signs of cutaneous irritation. abnormal vital sign (including blood pressure, pulse rate, respiratory rate and oral temperatures), 12-lead ECG, hematology (hemoglobin, hematocrit, platelet count, RBC count, WBC count, with differential), blood chemistry (BUN, creatinine, total bilirubin, alkaline phosphatase, AST, ALT, GGT, LDH, glucose, albumin, total protein, bicarbonate, phosphate, sodium, potassium, chloride, calcium, total cholesterol, uric acid) and urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, blood, nitrites, leukocytes, urobilinogen, microscopic urine analysis on abnormal findings) during the treatment period will be recorded and reported.
Measured: 19 days
Incidence of study drug related TEAEs
incidence of study drug related TEAEs (possibly, probably or definitely)
Measured: 19 days
Secondary outcomes (12)
Maximum observed concentration (Cmax)
Pharmacokinetics
Measured: 1 day
Time at which Cmax was first observed (Tmax)
Pharmacokinetics
Measured: 1 day
Area under the concentration curve from time 0 hour to 24 hour (AUC0-24)
Pharmacokinetics
Measured: 1 day
Area under the concentration curve for on dosing interval at steady state (AUC0-t)
Pharmacokinetics
Measured: 19 days
Cmax at steady state (Cmax_ss)
Pharmacokinetics
Measured: 19 days
Time at which Cmax_ss was first observed (Tmax_ss)
Pharmacokinetics
Measured: 19 days
Minimum observed or "trough" concentration at steady state (Cmin_ss)
Pharmacokinetics
Measured: 19 days
Average concentration at steady state (Cav_ss)
Pharmacokinetics
Measured: 19 days
AUC from time 0 and extrapolated to infinite time, total exposure (AUCinf)
Pharmacokinetics
Measured: 19 days
AUC from time 0 to the last non-zero concentration (AUClast)
Pharmacokinetics
Measured: 19 days
Biological half-life (T1/2 el)
Pharmacokinetics
Measured: 19 days
Terminal elimination rate constant (Kel)
Pharmacokinetics
Measured: 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start14 Jan 2020
- Primary completion11 Aug 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phoebe Zhang, Study director, Suzhou Kintor Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502901
- Sponsor's protocol ID
- KX0826-US-1002
- Status last verified
- Aug 2021
- First submitted
- 31 Jul 2020
- Last updated
- 11 Aug 2021
- Results posted
- No
- 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 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study in Healthy Male Subjects With Androgenetic Alopecia to Evaluate the Safety, Tolerability and PK of KX-826 Following Topical Multiple Dose Ascending
- ClinicalTrials.gov ID
- NCT04502901
- Acronym / sponsor ID
- KX0826-US-1002
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 11 Aug 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 6 Aug 2020 (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.
The study is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and PK of KX-826 following topical multiple ascending dose administration.
Detailed description
KX-826 topical solution will be applied to the scalp of healthy male subjects with androgenetic alopecia.
A total of 40 subjects will be evaluated with 32 subjects randomized to receive active drug and 8 subjects randomized to receive placebo in a double-blind fashion (10 subjects in each dose cohort with 8 subjects randomized to receive active drug and 2 subjects randomized to receive placebo for a total of 4 dose cohorts).
Cohort Dose of KX-826 Subjects
- 2.5 mg QD for 14 days 10 (8 active + 2 placebo)
- 5 mg QD for 14 days 10 (8 active + 2 placebo)
- 10 mg QD for 14 days 10 (8 active + 2 placebo)
- 20 mg QD for 14 days 10 (8 active + 2 placebo)
Dose escalation will not occur until review of the multiple dose safety from the previous dose cohort is completed. Safety assessments will include monitoring of AEs, vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead ECGs, skin irritation assessments and physical examination findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group -KX0826 | Experimental | Drug: KX0826KX0826 is tropically applied to the scalp of healthy male subjects once a day for 14 days. The applied dosage cohorts are 2.5mg, 5mg, 10mg and 20mg. |
| Control Group- Placebo | Placebo comparator | Other: PlaceboPlacebo is tropically applied to the scalp of healthy male subjects once a day for 14 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Are capable of giving informed consent and complying with study procedures;
- Are males between the ages of 18 and 60 years, inclusive;
- Have a clinical diagnosis of androgenetic alopecia;
- Considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs (systolic blood pressure ≥90 and ≤150 mmHg, diastolic blood pressure ≥50 and ≤95 mmHg and pulse rate ≥45 and ≤100 bpm; one repeat allowed to confirm out of range values);
- Have normal renal and hepatic function as determined by the screening laboratory results;
Key exclusion criteria (15 listed)
- Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
- Any visible skin disease, damage or condition at the application site which, in the opinion of the investigator, could compromise subject safety and/or interfere with the evaluation of the test site reaction;
- Subject has any dermatological disorders of the scalp;
- Subject has a history of hair transplants, hair weaves;
- Subject has hypersensitivity to previously prescribed minoxidil or finasteride;
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 |
|---|---|---|
| KX0826Also: Pyrilutamide, KX-826investigational AR antagonist | Drug | Experimental Group -KX0826 |
| PlaceboPlacebo of KX-826 | Other | Control Group- Placebo |
Primary outcome
Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessment, vital sign, ECG and clinical lab assessments
Time frame: 19 days
skin irritation assessment will be performed during the treatment period. The dermal response score will be based on a visual irritation scale (0-7) that rates the degree of erythema, edema and other signs of cutaneous irritation. abnormal vital sign (including blood pressure, pulse rate, respiratory rate and oral temperatures), 12-lead ECG, hematology (hemoglobin, hematocrit, platelet count, RBC count, WBC count, with differential), blood chemistry (BUN, creatinine, total bilirubin, alkaline phosphatase, AST, ALT, GGT, LDH, glucose, albumin, total protein, bicarbonate, phosphate, sodium, potassium, chloride, calcium, total cholesterol, uric acid) and urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, blood, nitrites, leukocytes, urobilinogen, microscopic urine analysis on abnormal findings) during the treatment period will be recorded and reported.
Incidence of study drug related TEAEs
Time frame: 19 days
incidence of study drug related TEAEs (possibly, probably or definitely)
12 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: 1 day
Time at which Cmax was first observed (Tmax)
Time frame: 1 day
Area under the concentration curve from time 0 hour to 24 hour (AUC0-24)
Time frame: 1 day
Area under the concentration curve for on dosing interval at steady state (AUC0-t)
Time frame: 19 days
Cmax at steady state (Cmax_ss)
Time frame: 19 days
Time at which Cmax_ss was first observed (Tmax_ss)
Time frame: 19 days
Minimum observed or "trough" concentration at steady state (Cmin_ss)
Time frame: 19 days
Average concentration at steady state (Cav_ss)
Time frame: 19 days
AUC from time 0 and extrapolated to infinite time, total exposure (AUCinf)
Time frame: 19 days
AUC from time 0 to the last non-zero concentration (AUClast)
Time frame: 19 days
Biological half-life (T1/2 el)
Time frame: 19 days
Terminal elimination rate constant (Kel)
Time frame: 19 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Phoebe Zhang study director
Suzhou Kintor Pharmaceuticals 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 KX0826 in people with Androgenetic Alopecia, run by Suzhou Kintor Pharmaceutical Inc, 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 8 inclusion and 15 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: finished, as of the sponsor's last update on 11 Aug 2021. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment-emergent adverse events (TEAE) by skin irritation assessment, vital sign, ECG and clinical lab assessments (time frame: 19 days). The study lists 2 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 11 Aug 2021.