Clinical trials: Proof of Concept
Basal Cell Carcinoma
Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II)
Part I is designed as a study of P-MNA application in healthy human volunteers. The goal of Part I is to determine several factors possibly affecting the rate and extent of microneedle array dissolution, such as anatomic…
- Trial name
- NCT04928222
- Testing
- Doxorubicin-containing MNA
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- SkinJect, Inc.
Atopic Dermatitis
A Study Evaluating the Safety and Efficacy of QGE031 in Atopic Dermatitis Patients
The study will assess the safety and efficacy of QGE031 in the treatment of moderate to severe atopic dermatitis patients. In addition, QGE031 levels in the blood will be measured and the effect of QGE031 on markers in the blood…
- Trial name
- NCT01552629
- Testing
- QGE031, Cyclosporine A
- Where
- 4 sites in Austria, France and 1 more
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Actinic Keratosis
Study on the Safety and Efficacy of Bimiralisib Gel in Participants Suffering From Actinic Keratosis
The aim of the study is to evaluate efficacy and safety of bimiralisib gel treatment for treatment of actinic keratosis (AK) on the face and/or scalp and/or back of hands
- Trial name
- NCT06319794
- Testing
- Bimiralisib
- Where
- 2 sites in Switzerland
- Volunteers
- 46 people
- Sponsor
- TORQUR
Heart Failure
Single Dose Escalation Study in Patients With Chronic Heart Failure
This study is to demonstrate the safety and tolerability of a single oral dose of BAY60-4552 in a single dose escalation design.
- Trial name
- NCT00565565
- Testing
- BAY60-4552
- Where
- 2 sites in Germany
- Volunteers
- 55 people
- Sponsor
- Bayer
Pruritus, Notalgia Paresthetica
Study to Evaluate the Efficacy and Safety of Oral Difelikefalin (CR845) for Moderate to Severe Pruritus in Subjects With Notalgia Paresthetica (KOMFORT)
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of twice-daily (BID) oral difelikefalin (CR845) in adult subjects with notalgia paresthetica and moderate to severe…
- Trial name
- NCT04706975
- Testing
- difelikefalin 2.0 mg
- Where
- 36 sites in United States, Canada
- Volunteers
- 126 people
- Sponsor
- Cara Therapeutics, Inc.
Retinitis Pigmentosa (RP)
Oral QLT091001 in Retinitis Pigmentosa (RP) Subjects With an Autosomal Dominant Mutation in Retinal Pigment Epithelial 65 Protein (RPE65)
The purpose of this study is: To evaluate whether 7-day treatment with oral QLT091001 can improve visual function in RP subjects with an autosomal dominant mutation in RPE65.
- Trial name
- NCT01543906
- Testing
- QLT091001
- Where
- 2 sites in Canada, Ireland
- Volunteers
- 5 people
- Sponsor
- QLT Inc.
Penile Elongation
A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol
The objective of this study is to examine and quantify the efficacy and safety of a new treatment protocol using platelet-rich plasma for penile length enhancement.
- Trial name
- NCT04231422
- Testing
- Platelet-rich plasma
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Judson Brandeis
Healthy Volunteer
A Human Tick Kill Study to Investigate the Safety, Tolerability, and Whole Blood Concentration of TP-05
This is a Phase 2a, randomized, double-blind, proof-of-concept, single-center study evaluating the safety, tolerability, and whole blood concentration of TP-05 (lotilaner) in the killing of ticks after they have attached to human…
- Trial name
- NCT05387083
- Testing
- Low Dose TP-05, High Dose TP-05
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tarsus Pharmaceuticals, Inc.
Fibromyalgia Syndrome
The Use of Rotigotine for Treatment of Reducing Signs and Symptoms of Fibromyalgia in Adults.
This trial is to investigate the efficacy and safety of rotigotine as compared to placebo in reducing signs and symptoms of fibromyalgia syndrome.
- Trial name
- SP888 (NCT00464737)
- Testing
- Rotigotine
- Where
- 35 sites in United States
- Volunteers
- 230 people
- Sponsor
- UCB Pharma
Acute Lung Injury
Treatment and Prevention of Acute Lung Injury (ALI) in Patients With COVID-19 Infection
The study aims to assess the potential benefit and evaluate the safety and tolerability of a single subcutaneous (SC) dose of VIB7734 in hospitalized patients with documented infection of severe acute respiratory syndrome…
- Trial name
- ALI (NCT04526912)
- Testing
- VIB7734
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Viela Bio
Retinitis Pigmentosa
A First-in-human, Proof of Concept Study of CPK850 in Patients With RLBP1 Retinitis Pigmentosa
The purpose of this first-in-human study is to explore the maximum tolerated dose (MTD) of CPK850 as determined by the single ascending dose ranging portion of the study.
- Trial name
- NCT03374657
- Testing
- CPK850
- Where
- Sweden
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
Atopic Dermatitis
LEO 29102 Cream in the Treatment of Atopic Dermatitis
This is a proof of concept and dose finding Phase II trial comparing 5 dose strengths with vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment regimen in mild to moderate atopic dermatitis…
- Trial name
- NCT01037881
- Testing
- LEO 29102, Elidel®
- Where
- 3 sites in Canada, Finland and 1 more
- Volunteers
- 183 people
- Sponsor
- LEO Pharma
Cluster Headache
Effect of Ketamine Intranasal Spray in Treatment of Chronic Cluster Headache
Ketamine has been used clinically IV in a very safe manner by a very small number of clinicians, to treat migraines and CH, and various other rarer pain disorders, including mixed headache and neuropathic pain clinical syndromes.
- Trial name
- NCT04179266
- Testing
- Ketamine
- Where
- Denmark
- Volunteers
- 23 people
- Sponsor
- CCH Pharmaceuticals
Stress Urinary Incontinence
GTx-024 as a Treatment for Stress Urinary Incontinence in Women
The purpose of this study is to determine whether GTx-024 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.
- Trial name
- NCT02658448
- Testing
- GTx-024
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- GTx
Intracerebral Hemorrhage
A Study to Evaluate the Safety, Tolerability and the Effects of Ixodes Ricinus-Contact Phase Inhibitor (Ir-CPI) in Adult Patients With Spontaneous Intracerebral Haemorrhage
The purpose of the study is to provide a first assessment of safety, tolerability and efficacy of Ir-CPI, administered on top of standard-of-care, on secondary brain injury in patients with spontaneous intracerebral haemorrhage.
- Trial name
- BIRCH (NCT05970224)
- Testing
- Ir-CPI
- Where
- 8 sites in Belgium
- Volunteers
- 23 people
- Sponsor
- Bioxodes S.A.
Sjögren's Syndrome
Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome
The primary objective of this study is to evaluate the efficacy of treatment with either lulizumab or BMS-986142 versus placebo in subjects with moderate to severe primary Sjögren's syndrome as measured by the change from…
- Trial name
- NCT02843659
- Testing
- BMS-931699, BMS-986142
- Where
- 34 sites in United States, Australia and 9 more
- Volunteers
- 45 people
- Sponsor
- Bristol-Myers Squibb
Malaria
Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAE609 at 30 mg/day
- Trial name
- NCT01524341
- Testing
- KAE609
- Where
- 3 sites in Thailand
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
Membranous Nephropathy
A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients with Primary Membranous Nephropathy (ZL-1103-014)
To evaluate the efficacy and safety of efgartigimod IV in Chinese patients with primary membranous nephropathy (pMN).
- Trial name
- NCT05810961
- Testing
- efgartigimod IV
- Where
- 31 sites in China
- Volunteers
- 8 people
- Sponsor
- argenx
Duchenne Muscular Dystrophy
Proof of Concept Study to Assess Activity and Safety of SMT C1100 (Ezutromid) in Boys With Duchenne Muscular Dystrophy (DMD)
To Assess the Activity and Safety of SMT C1100 (Ezutromid) in Paediatric Male Participants with Duchenne Muscular Dystrophy (DMD).
- Trial name
- NCT02858362
- Testing
- Ezutromid
- Where
- 16 sites in United States, United Kingdom
- Volunteers
- 43 people
- Sponsor
- Summit Therapeutics
Hepatitis C
Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected Patients
To evaluate the antiviral activity of 3 days of BZF961. To determine safety and tolerability of BZF961 in HCV patients. To evaluate pharmacokinetics of BZF961 in HCV patients.
- Trial name
- CBZF961X2201 (NCT01825980)
- Testing
- BZF961, Ritonavir
- Where
- 3 sites in United States
- Volunteers
- 54 people
- Sponsor
- Novartis Pharmaceuticals