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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04945226




Registration number
NCT04945226
Ethics application status
Date submitted
25/06/2021
Date registered
30/06/2021
Date last updated
4/03/2022

Titles & IDs
Public title
A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001
Scientific title
A Randomized, Open-Label, Exploratory, Pharmacokinetic, Sequential Single Ascending Dose Study of IVL3001 Versus Propecia (Finasteride) Tablets in Healthy Adult Participants
Secondary ID [1] 0 0
IVL3001-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Androgenetic Alopecia 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Finasteride 1mg Tablet
Treatment: Drugs - IVL3001

Active Comparator: Propecia - Propecia Tablet, QD, PO

Experimental: IVL3001 (A mg) - S.C, Single Dose.

Experimental: IVL3001 (B mg) - S.C, Single Dose.

Experimental: IVL3001 (C mg) - S.C, Single Dose.


Treatment: Drugs: Finasteride 1mg Tablet
Propecia Tablet 1mg

Treatment: Drugs: IVL3001
Finasteride long acting injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AUClast of IVL3001
Timepoint [1] 0 0
Pre-dose, 1008 hours
Primary outcome [2] 0 0
AUCinf of IVL3001
Timepoint [2] 0 0
Pre-dose, 1008 hours
Primary outcome [3] 0 0
AUC0-1008h of IVL3001
Timepoint [3] 0 0
Pre-dose, 1008 hours
Primary outcome [4] 0 0
AUClast of Propecia
Timepoint [4] 0 0
Pre-dose, 816 hours
Primary outcome [5] 0 0
AUCinf of Propecia
Timepoint [5] 0 0
Pre-dose, 816 hours
Primary outcome [6] 0 0
AUC0-672h of Propecia
Timepoint [6] 0 0
Pre-dose, 672 hours

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/02/2022
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Inventage Lab., Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001
Trial website
https://clinicaltrials.gov/ct2/show/NCT04945226
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries