A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001

NCT04945226 | Completed Phase 1 DMC

• 1 other identifier: IVL3001-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (6)

• AUClast of IVL3001

  Area under the concentration-time curve from time zero to last

  Pre-dose, 1008 hours

• AUCinf of IVL3001

  Area under the concentration-time curve from time zero to infinity

  Pre-dose, 1008 hours

• AUC0-1008h of IVL3001

  Area under the concentration-time curve from time zero to 1008 hours

  Pre-dose, 1008 hours

• AUClast of Propecia

  Area under the concentration-time curve from time zero to last

  Pre-dose, 816 hours

• AUCinf of Propecia

  Area under the concentration-time curve from time zero to infinity

  Pre-dose, 816 hours

• AUC0-672h of Propecia

  Area under the concentration-time curve from time zero to 672hours

  Pre-dose, 672 hours

Study Arms (4)

Propecia

ACTIVE COMPARATOR

Propecia Tablet, QD, PO

Drug: Finasteride 1mg Tablet

IVL3001 (A mg)

EXPERIMENTAL

S.C, Single Dose.

Drug: IVL3001

IVL3001 (B mg)

EXPERIMENTAL

S.C, Single Dose.

Drug: IVL3001

IVL3001 (C mg)

EXPERIMENTAL

S.C, Single Dose.

Drug: IVL3001

Interventions

Finasteride 1mg Tablet DRUG

Propecia Tablet 1mg

Propecia

IVL3001 DRUG

Finasteride long acting injection

IVL3001 (A mg); IVL3001 (B mg); IVL3001 (C mg)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inventage Lab., Inc.: lead

Study Sites (1)

Nucleus Network

Brisbane, Australia

Location

Related Publications (1)

• 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.

  PMID: 38833144 DERIVED

MeSH Terms

Conditions

Alopecia

Interventions

Finasteride; Tablets

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Cohort 1 / Cohort 2 (Group 1, Group 2) / Cohort 3

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: June 30, 2021
• Study Start: September 21, 2021
• Primary Completion: February 8, 2022
• Study Completion: February 8, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)