Androgenetic AlopeciaPhase 1/2NCT04945226
A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001
A Phase 1/2 study testing Finasteride 1mg Tablet and IVL3001 in people with Androgenetic Alopecia, run by Inventage Lab., Inc. at 1 site in Australia.
Trial summary
A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001 Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Finasteride 1mg Tablet and IVL3001
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 21 Sep 2021to 8 Feb 2022
- Phase
- Phase 1/2
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male, non-smoker or, if a moderate or occasional smoker (< 10 cigarettes per day or nicotine equivalent) must agree to abstain from smoking from 48 h before first IP administration through to completion of the final EOS/ET visit, aged ≥ 18 to 55 years (inclusive at the time of informed consent)
- In good general health, in the opinion of the Investigator, with no significant medical history, and have no clinically significant abnormalities on complete physical examination, 12-lead ECG, heart rate, and BP, both at Screening and before administration of the initial dose of IP
- Body mass index (BMI) between ≥ 18 kg/m2 and ≤ 32 kg/m2 and a minimum weight ≥ 50 kg and ≤ 100 kg at Screening
- Clinical laboratory values within normal limits, with normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate
- Ability and willingness to attend the necessary visits to the CRU and be domiciled overnight
- Willing and able to provide written informed consent after the nature of the study has been explained and prior to the commencement of any protocol-specific study procedures
Who cannot join
- Prior or ongoing medical conditions, medical history, physical examination findings, or laboratory abnormalities that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the participant
- Presence or history of any clinically significant blood, kidney, endocrine, lung, gastrointestinal tract, cardiovascular, liver, or neurological condition
- Presence of any underlying physical or psychological (eg, depression) medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol. Mild depression and anxiety that has been resolved at least 6-12 months ago is accepted.
- Presence of any medical condition that may affect oral drug absorption (eg, gastrectomy, gall bladder removal, bariatric surgery, gastric bypass and sleeve, bowel resection)
- Hypersensitivity to finasteride or to any excipient of the IPs
- Age adjusted PSA between 0 2.5 ng/mL for subjects ≤ 50 years of age and between 0-4 ng/mL for subjects > 50 years of age at Screening, unless deemed not clinically significant by the Investigator or delegate
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- History or known presence of any prostatic problem (infection, prostate cancer, stricture disease, hypotonic bladder or other neurogenic disorder that might mimic BPH)
- Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), HIV antigen or antibody at Screening
- Positive toxicology screening panel (urine test including qualitative identification of barbiturates, tetrahydrocannabinol [THC], amphetamines, benzodiazepines, opiates and cocaine), or a positive alcohol breath (or urine), or cotinine test
- History of alcohol or substance abuse or dependency, or history of recreational intravenous (IV) drug use over the last 1 year (by self-declaration)
- Regular alcohol consumption defined as > 21 alcohol units per week (where 1 unit = 284 mL of beer, 25 mL of 40% spirit, or a 125 mL glass of wine) within 6 months of Screening.
- Use of any IP or investigational medical device within 3 months prior to Screening, or five half-lives of the product (whichever is the longest), or participation in more than 4 investigational drug studies within 1 year prior to Screening
- Use of any drug known to significantly induce or inhibit drug absorption or metabolism within 30 days prior to dosing
- An employee, or relative of an employee, directly involved in the conduct of the study
- Unwilling to refrain from strenuous exercise from 48 hours prior to admission to the CRU at Day -1 and 48 hours prior to each follow-up
- Presence of sexual dysfunction such as decreased libido, erectile dysfunction, or ejaculation disorder
- Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2 at Screening
- Any reason which, in the opinion of the PI, would prevent the subject from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Exploratory, Pharmacokinetic, Sequential Single Ascending Dose Study of IVL3001 Versus Propecia (Finasteride) Tablets in Healthy Adult Participants
A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001
Read the detailed description
A Randomized, Open-Label, Exploratory, Pharmacokinetic, Sequential Single Ascending dose Study of IVL3001 Versus Propecia (Finasteride) Tablets in Healthy Adult Participants
- Conditions
- Androgenetic Alopecia
- Being tested
- Finasteride 1mg Tablet, IVL3001
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finasteride 1mg TabletDrug
Propecia Tablet 1mg
IVL3001Drug
Finasteride long acting injection
| Study group | Role | What they receive |
|---|---|---|
| Propecia | Active comparator | Propecia Tablet, QD, PO Receives: Drug: Finasteride 1mg Tablet |
| IVL3001 (A mg) | Experimental | S.C, Single Dose. Receives: Drug: IVL3001 |
| IVL3001 (B mg) | Experimental | S.C, Single Dose. Receives: Drug: IVL3001 |
| IVL3001 (C mg) | Experimental | S.C, Single Dose. Receives: Drug: IVL3001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUClast of IVL3001
Area under the concentration-time curve from time zero to last
Measured: Pre-dose, 1008 hours
AUCinf of IVL3001
Area under the concentration-time curve from time zero to infinity
Measured: Pre-dose, 1008 hours
AUC0-1008h of IVL3001
Area under the concentration-time curve from time zero to 1008 hours
Measured: Pre-dose, 1008 hours
AUClast of Propecia
Area under the concentration-time curve from time zero to last
Measured: Pre-dose, 816 hours
AUCinf of Propecia
Area under the concentration-time curve from time zero to infinity
Measured: Pre-dose, 816 hours
AUC0-672h of Propecia
Area under the concentration-time curve from time zero to 672hours
Measured: Pre-dose, 672 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start21 Sep 2021
- Primary completion8 Feb 2022
- Study completion8 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Cohort 1 / Cohort 2 (Group 1, Group 2) / Cohort 3
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inventage Lab., Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945226
- Sponsor's protocol ID
- IVL3001-001
- Status last verified
- Feb 2022
- First submitted
- 25 Jun 2021
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim H, Ryu C, Lee M, Lee KR, Kim J. A Phase I, Open-Label, Sequential, Single-Dose Clinical Trial to Evaluate the Pharmacokinetic, Pharmacodynamic, and Safety of IVL3001, a Finasteride-Based Novel Long-Acting Injection for Androgenetic Alopecia. Adv Ther. 2024 Jul;41(7):2936-2952. doi: 10.1007/s12325-024-02890-1. Epub 2024 Jun 4.
PubMed 38833144
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Exploratory, Pharmacokinetic, Sequential Single Ascending Dose Study of IVL3001 Versus Propecia (Finasteride) Tablets in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT04945226
- Acronym / sponsor ID
- IVL3001-001
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Inventage Lab., Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 30 Jun 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.
A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001
Detailed description
A Randomized, Open-Label, Exploratory, Pharmacokinetic, Sequential Single Ascending dose Study of IVL3001 Versus Propecia (Finasteride) Tablets in Healthy Adult Participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Cohort 1 / Cohort 2 (Group 1, Group 2) / Cohort 3
| Arm | Type | Receives |
|---|---|---|
| Propecia | Active comparator | Drug: Finasteride 1mg TabletPropecia Tablet, QD, PO |
| IVL3001 (A mg) | Experimental | Drug: IVL3001S.C, Single Dose. |
| IVL3001 (B mg) | Experimental | Drug: IVL3001S.C, Single Dose. |
| IVL3001 (C mg) | Experimental | Drug: IVL3001S.C, Single Dose. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male, non-smoker or, if a moderate or occasional smoker (< 10 cigarettes per day or nicotine equivalent) must agree to abstain from smoking from 48 h before first IP administration through to completion of the final EOS/ET visit, aged ≥ 18 to 55 years (inclusive at the time of informed consent)
- In good general health, in the opinion of the Investigator, with no significant medical history, and have no clinically significant abnormalities on complete physical examination, 12-lead ECG, heart rate, and BP, both at Screening and before administration of the initial dose of IP
- Body mass index (BMI) between ≥ 18 kg/m2 and ≤ 32 kg/m2 and a minimum weight ≥ 50 kg and ≤ 100 kg at Screening
- Clinical laboratory values within normal limits, with normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate
- Ability and willingness to attend the necessary visits to the CRU and be domiciled overnight
Key exclusion criteria (18 listed)
- Prior or ongoing medical conditions, medical history, physical examination findings, or laboratory abnormalities that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the participant
- Presence or history of any clinically significant blood, kidney, endocrine, lung, gastrointestinal tract, cardiovascular, liver, or neurological condition
- Presence of any underlying physical or psychological (eg, depression) medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol. Mild depression and anxiety that has been resolved at least 6-12 months ago is accepted.
- Presence of any medical condition that may affect oral drug absorption (eg, gastrectomy, gall bladder removal, bariatric surgery, gastric bypass and sleeve, bowel resection)
- Hypersensitivity to finasteride or to any excipient of the IPs
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 |
|---|---|---|
| Finasteride 1mg TabletPropecia Tablet 1mg | Drug | Propecia |
| IVL3001Finasteride long acting injection | Drug | IVL3001 (A mg), IVL3001 (B mg), IVL3001 (C mg) |
Primary outcome
AUClast of IVL3001
Time frame: Pre-dose, 1008 hours
Area under the concentration-time curve from time zero to last
AUCinf of IVL3001
Time frame: Pre-dose, 1008 hours
Area under the concentration-time curve from time zero to infinity
AUC0-1008h of IVL3001
Time frame: Pre-dose, 1008 hours
Area under the concentration-time curve from time zero to 1008 hours
AUClast of Propecia
Time frame: Pre-dose, 816 hours
Area under the concentration-time curve from time zero to last
AUCinf of Propecia
Time frame: Pre-dose, 816 hours
Area under the concentration-time curve from time zero to infinity
AUC0-672h of Propecia
Time frame: Pre-dose, 672 hours
Area under the concentration-time curve from time zero to 672hours
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 4 Mar 2022.
- Derived from this study: PubMed 38833144Kim H, Ryu C, Lee M, Lee KR, Kim J. A Phase I, Open-Label, Sequential, Single-Dose Clinical Trial to Evaluate the Pharmacokinetic, Pharmacodynamic, and Safety of IVL3001, a Finasteride-Based Novel Long-Acting Injection for Androgenetic Alopecia. Adv Ther. 2024 Jul;41(7):2936-2952. doi: 10.1007/s12325-024-02890-1. Epub 2024 Jun 4.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Finasteride 1mg Tablet and IVL3001 in people with Androgenetic Alopecia, run by Inventage Lab., Inc. at 1 site in Australia.
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 18 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 4 Mar 2022. 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 Australia. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
AUClast of IVL3001 (time frame: Pre-dose, 1008 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04945226, which also lists 1 linked publication.
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 4 Mar 2022.