Clinical trials: Safety Study
Healthy Volunteers
Single and Multiple-Ascending Dose Study of CRN00808 in Healthy Volunteers
This single-center study will be conducted in 3 phases: a single-ascending dose phase (up to 8 cohorts, 8 subjects/cohort), a multiple-dose phase (up to 5 cohorts, 9 subjects/cohort), and a midazolam drug-drug interaction phase…
- Trial name
- NCT03276858
- Testing
- CRN00808, Midazolam oral solution
- Where
- Australia
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Crinetics Pharmaceuticals Inc.
Hypogonadism
Open-Label Study of ARD-0403 in Testosterone Deficient Men
Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient wellbeing.
- Trial name
- NCT00448955
- Testing
- ARD-0403
- Where
- 12 sites in United States
- Volunteers
- 150 people
- Sponsor
- Ardana Bioscience Ltd
Adult Growth Hormone Deficiency, Endocrine System Diseases
A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
This was a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly.
- Conditions
- Adult Growth Hormone Deficiency, Endocrine System Diseases, Hormone Deficiency
- Trial name
- NCT05171855
- Testing
- Lonapegsomatropin
- Where
- 85 sites in United States, Armenia and 19 more
- Volunteers
- 220 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis
A Study of EDP-297 in Healthy Subjects
This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.
- Trial name
- NCT04559126
- Testing
- EDP-297
- Where
- Netherlands
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Thyroid Eye Disease
A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease
The main goal of this study is to learn how teprotumumab will be processed in the body (Pharmacokinetics) subcutaneously and whether it is safe and tolerable after administration into adult patients with thyroid eye disease.
- Trial name
- NCT06389578
- Testing
- Teprotumumab
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- Amgen
Rheumatoid Arthritis
Long-Term Efficacy and Safety of CT-P10 in Patients With RA
This is an open-label, single-arm, multicenter, efficacy, and safety maintenance study of the Phase 1 Study CT-P10 1.1. This study is designed to assess the long-term efficacy and safety of CT-P10 co-administered with MTX and…
- Trial name
- NCT01873443
- Testing
- Rituximab, MTX, folic acid
- Where
- South Korea
- Volunteers
- 87 people
- Sponsor
- Celltrion
Healthy
Study to Investigate the Absolute Bioavailability of a Single Oral Dose of Ponesimod in Healthy Male Subjects
This study consists of a single-dose pilot phase and a randomized, two-way crossover, single-dose main phase.The aim of this study is to evaluate the absolute bioavailability of the oral formulation (tablet) of ponesimod compared…
- Trial name
- NCT02068235
- Testing
- Ponesimod 5mg i.v., Ponesimod i.v., Ponesimod 10 mg tablet
- Where
- United Kingdom
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Actelion
Diabetes Mellitus, Type 2
Efficacy and Safety of Empagliflozin (BI 10773) / Linagliptin (BI 1356) Fixed Dose Combination in Treatment naïve and Metformin Treated Type 2 Diabetes Patients
This trial will evaluate use of BI 10773/linagliptin once daily (qd) fixed dose combination (FDC) in treatment naïve and metformin treated patients with type 2 diabetes mellitus to support approval by regulatory authorities.
- Trial name
- NCT01422876
- Testing
- high dose FDC, BI 10773 high dose
- Where
- 211 sites in United States, Argentina and 20 more
- Volunteers
- 1,405 people
- Sponsor
- Boehringer Ingelheim
Huntington Disease
A Study to Evaluate the Safety and Efficacy of PTC518 in Participants With Huntington's Disease (HD)
The primary goal of this study is to evaluate the safety and pharmacodynamic effects of PTC518 compared with placebo in participants with HD.
- Trial name
- NCT05358717
- Testing
- PTC518
- Where
- 28 sites in United States, Australia and 9 more
- Volunteers
- 159 people
- Sponsor
- Novartis Pharmaceuticals
Refractory Solid Tumors, Cancer Tumor
An Open-Label, Dose-Escalation Study of AZD2461
This study is being conducted to test study drug AZD2461 to see how it may work to treat solid tumors. The main purpose of this study is to determine the safety and tolerability of AZD2461.
- Trial name
- NCT01247168
- Testing
- AZD2461
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- AstraZeneca
HIV Infections
Tenofovir DF + Efavirenz (TDF+EFV) Versus Tenofovir DF + Efavirenz + Lamivudine (TDF+EFV+3TC) Maintenance Regimen in Virologically Controlled Patients: COOL Trial
Primary objective: Evaluation of the efficacy of TDF+3TC+EFV versus TDF+EFV QD to maintain plasma HIV-1 RNA BLQ (< 50 copies/mL) (c/mL) at 48 weeks (W48) Main Secondary objectives: Comparison of the two arms for genotypic…
- Trial name
- COOL (NCT00643968)
- Testing
- EFV+TDF, EFV+3TC+TDF
- Where
- France
- Volunteers
- 140 people
- Sponsor
- Gilead Sciences
Overactive Bladder
Extension Study of Vibegron in Men With Overactive Bladder (OAB) Symptoms on Pharmacological Therapy for Benign Prostatic Hyperplasia
This study will assess the long-term safety of vibegron when dosed up to 52 weeks in men with overactive bladder (OAB) symptoms on pharmacological therapy for Benign Prostatic Hyperplasia (BPH) who previously completed treatment…
- Trial name
- NCT04103450
- Testing
- Vibegron
- Where
- 35 sites in United States, Poland
- Volunteers
- 276 people
- Sponsor
- Urovant Sciences GmbH
Type 2 Diabetes Mellitus
A Study to Evaluate the Efficacy and Safety of DA-302168S Tablets in Subjects With Type 2 Diabetes
This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study aims to assess the efficacy, safety, and PK characteristics of DA-302168S tablets in Chinese T2DM participants, and to provide…
- Trial name
- NCT07755150
- Testing
- DA-302168S
- Where
- China
- Volunteers
- 272 people
- Sponsor
- Chendu DIAO Pharmaceutical Group CO., LTD.
Renal Cell Carcinoma (RCC), Clear-cell Renal Cell Carcinoma
A Dose Escalation, Safety and Activity Study of CDX-014 in Patients With Renal Cell Carcinoma and Ovarian Clear Cell Carcinoma
This is a study to determine the safety of CDX-014 and effectiveness (how well the drug works).
- Conditions
- Renal Cell Carcinoma (RCC), Clear-cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Kidney Neoplasms
- Trial name
- NCT02837991
- Testing
- CDX-014
- Where
- 5 sites in United States
- Volunteers
- 16 people
- Sponsor
- Celldex Therapeutics
Thrombocytopenia, Neutropenia
Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal Cancer
This research study will investigate the safety and effectiveness of two different dose levels of a new, unapproved drug to be given along with the chemotherapy regimens gemcitabine and carboplatin or gemcitabine and cisplatin…
- Conditions
- Thrombocytopenia, Neutropenia, Lymphopenia, Anemia
- Trial name
- NCT00771810
- Testing
- TXA127
- Where
- 6 sites in United States
- Volunteers
- 34 people
- Sponsor
- Tarix Pharmaceuticals
Advanced Solid Tumors
Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors
This is a first-in-human, Phase I, multicenter, open label, dose escalation study to evaluate the DLTs and MTD and to determine the recommended Phase 2 dose (RP2D) of CPX-POM administered IV in patients with any histologically…
- Trial name
- NCT03348514
- Testing
- CPX-POM - 30 mg/m^2, CPX-POM - 60 mg/m^2, CPX-POM - 120 mg/m^2
- Where
- 5 sites in United States
- Volunteers
- 19 people
- Sponsor
- CicloMed LLC
Magnetic Resonance Imaging
Phase Ib, Administration the IOP Injection for MRI Contrast Agent in Healthy Subjects
The objective of the study is to assess the dose dependent changes in MRI signal intensity (SI) in liver after IOP Injection intravenous administration in healthy volunteers.
- Trial name
- NCT03399214
- Testing
- IOP Injection
- Where
- Taiwan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- MegaPro Biomedical Co. Ltd.
Male Hypogonadism
Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU) in Hypogonadal Men
The purpose of this study is to determine the safety and efficacy of an oral testosterone undecanoate formulation for use as testosterone-replacement therapy in men with low testosterone.
- Trial name
- NCT01403116
- Testing
- Oral testosterone undecanoate, topical testosterone gel
- Where
- 30 sites in United States, Germany
- Volunteers
- 325 people
- Sponsor
- Clarus Therapeutics, Inc.
Infection, Bacterial
A First-in-Human Study With XAB05 in Healthy Subjects
This study is a randomized, placebo-controlled, first in human, single ascending dose Phase 1 study
- Trial name
- NCT05307406
- Testing
- Experimental
- Where
- Netherlands
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Xenothera SAS
Pulmonary Disease, Chronic Obstructive, COPD
Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) in Chronic Obstructive Pulmonary Disease (COPD)
The study is designed to obtain safety and efficacy data on three dose levels of indacaterol when delivered via an SDDPI in patients with COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive, COPD, Lung Diseases, Obstructive
- Trial name
- NCT00396604
- Testing
- indacaterol maleate
- Where
- Belgium
- Volunteers
- 51 people
- Sponsor
- Novartis