Androgenetic AlopeciaPhase 1NCT04984707
Safety, Tolerability and Pharmacokinetics of KX826 in Healthy Male Subjects With Androgenetic Alopecia Following Topical Single Ascending Dose Administration
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, Parallel Group, Dose Escalation Study in Healthy Male Subjects with Androgenetic Alopecia to Evaluate the Safety, Tolerability and Pharmacokinetics of KX-826 Following Topical Single Ascending Dose Administration Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- 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
- 28 Jan 2019to 24 Oct 2019
- 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
- No healthy volunteers
- 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 AGA;
- Considered healthy by the PI, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs;
- 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 clinical research center.
Who cannot join
- Clinically significant history of gastrointestinal (GI), 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 (HBs Ag), or hepatitis C (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 was 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 Pharmacokinetics of KX-826 Following Topical Single Ascending Dose Administration
The study is a Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study in Healthy Male Subjects with Androgenetic Alopecia to Evaluate the Safety, Tolerability and Pharmacokinetics of KX-826 Following Topical Single Ascending Dose Administration
Read the detailed description
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 (ten subjects in each dose cohort with two subjects randomized to placebo for total of four dose cohorts).Subjects were to be assigned to 1 of the 4 dose levels, 3 mg. 12 mg, 48 mg and 96 mg of KX-826 or placebo to match the active product, administered as a topical application.
- 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
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 with Androgenetic Alopecia with a single dose.The applied dosage cohorts are 3mg, 12mg, 48mg and 96mg. Receives: Drug: KX0826 |
| Control Group- Placebo | Placebo comparator | Placebo is tropically applied to the scalp of healthy male subjects with Androgenetic Alopecia with a single dose. 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 assessments
Skin irritation assessments 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.
Measured: 3 days
Incidence of treatment-emergent adverse events (TEAE) by vital signs measurements
vital signs (including blood pressure, pulse rate, respiratory rate and oral temperatures)
Measured: 3 days
Incidence of treatment-emergent adverse events (TEAE) by ECG assessment
12-lead ECG
Measured: 3 days
Incidence of treatment-emergent adverse events (TEAE) by clinical lab tests
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)
Measured: 3 days
Incidence of study drug related TEAEs
incidence of study drug related TEAEs (possibly, probably or definitely)
Measured: 3 days
Secondary outcomes (8)
AUC from time 0 and extrapolated to infinite time, total exposure(AUCinf)
Pharmacokinetics
Measured: 48 hours
AUC from time 0 to the last non-zero concentration(AUClast)
Pharmacokinetics
Measured: 48 hours
Maximum observed concentration (Cmax)
Pharmacokinetics
Measured: 48 hours
Time at which Cmax was first observed(Tmax)
Pharmacokinetics
Measured: 48 hours
half life（T½）
Pharmacokinetics
Measured: 48 hours
Apparent total systemic clearance, calculated as Dose/AUCinf(Cl/F)
Pharmacokinetics
Measured: 48 hours
Apparent volume of distribution(Vd/F)
Pharmacokinetics
Measured: 48 hours
elimination rate constant（Kel）
Pharmacokinetics
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start28 Jan 2019
- Primary completion11 Apr 2019
- Study completion24 Oct 2019
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
- David J Wyatt, MD, Principal investigator, inVentiv Health Clinical Research Services,LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984707
- Sponsor's protocol ID
- KX0826-US-1001
- Status last verified
- Jul 2021
- First submitted
- 19 Jul 2021
- Last updated
- 30 Jul 2021
- 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 30 Jul 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 Pharmacokinetics of KX-826 Following Topical Single Ascending Dose Administration
- ClinicalTrials.gov ID
- NCT04984707
- Acronym / sponsor ID
- KX0826-US-1001
- 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
- 28 Jan 2019 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- 24 Oct 2019 (actual)
- First posted
- 30 Jul 2021 (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, Parallel Group, Dose Escalation Study in Healthy Male Subjects with Androgenetic Alopecia to Evaluate the Safety, Tolerability and Pharmacokinetics of KX-826 Following Topical Single Ascending Dose Administration
Detailed description
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 (ten subjects in each dose cohort with two subjects randomized to placebo for total of four dose cohorts).Subjects were to be assigned to 1 of the 4 dose levels, 3 mg. 12 mg, 48 mg and 96 mg of KX-826 or placebo to match the active product, administered as a topical application.
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 with Androgenetic Alopecia with a single dose.The applied dosage cohorts are 3mg, 12mg, 48mg and 96mg. |
| Control Group- Placebo | Placebo comparator | Other: PlaceboPlacebo is tropically applied to the scalp of healthy male subjects with Androgenetic Alopecia with a single dose. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not 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 AGA;
- Considered healthy by the PI, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs;
- Have normal renal and hepatic function as determined by the screening laboratory results;
Key exclusion criteria (15 listed)
- Clinically significant history of gastrointestinal (GI), 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-826AR 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 assessments
Time frame: 3 days
Skin irritation assessments 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.
Incidence of treatment-emergent adverse events (TEAE) by vital signs measurements
Time frame: 3 days
vital signs (including blood pressure, pulse rate, respiratory rate and oral temperatures)
Incidence of treatment-emergent adverse events (TEAE) by ECG assessment
Time frame: 3 days
12-lead ECG
Incidence of treatment-emergent adverse events (TEAE) by clinical lab tests
Time frame: 3 days
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)
Incidence of study drug related TEAEs
Time frame: 3 days
incidence of study drug related TEAEs (possibly, probably or definitely)
8 secondary outcomes
AUC from time 0 and extrapolated to infinite time, total exposure(AUCinf)
Time frame: 48 hours
AUC from time 0 to the last non-zero concentration(AUClast)
Time frame: 48 hours
Maximum observed concentration (Cmax)
Time frame: 48 hours
Time at which Cmax was first observed(Tmax)
Time frame: 48 hours
half life（T½）
Time frame: 48 hours
Apparent total systemic clearance, calculated as Dose/AUCinf(Cl/F)
Time frame: 48 hours
Apparent volume of distribution(Vd/F)
Time frame: 48 hours
elimination rate constant（Kel）
Time frame: 48 hours
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 30 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Active, not recruitingPhase 3
Evaluation of Efficacy and Safety of Oral Minoxidil 1 mg in Female Androgenetic Alopecia
Androgenetic Alopecia, Female Pattern Baldness
RecruitingPhase 1/2
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
Androgenetic Alopecia (AGA), Healthy Volunteers - Male and Female
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.
David J Wyatt, MD principal investigator
inVentiv Health Clinical Research Services,LLC
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 30 Jul 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 assessments (time frame: 3 days). The study lists 5 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 30 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.