Clinical trials: Safety and Pharmacokinetics
Chronic Kidney Disease, Chronic Kidney Disease, Stage 3 (Moderate)
Study to Assess PK, Safety and Tolerability in Patients With DM and CKD
An open-label, phase IB, multi-center study evaluating DM199 in subjects with Type 1 Diabetes or Type 2 Diabetes and Stage 3 or 4 Chronic Kidney Disease.
- Conditions
- Chronic Kidney Disease, Chronic Kidney Disease, Stage 3 (Moderate), Chronic Kidney Disease, Stage 4 (Severe), Diabetes
- Trial name
- NCT03795389
- Testing
- DM199
- Where
- 3 sites in United States
- Volunteers
- 33 people
- Sponsor
- DiaMedica Therapeutics Inc
Hemophilia A
Evaluation of SCT800 in Prophylaxis Therapy on Previous Treated Patients With Severe Hemophilia A
This study is a multi-center, open-label, single-arm trial to evaluate the efficacy,safety and pharmacokinetics of SCT800 in regular prophylaxis and perioperative treatment in patients (≥12 years old) with severe hemophilia A who…
- Trial name
- NCT03815318
- Testing
- Recombinant Human Coagulation FVIII
- Where
- China
- Volunteers
- 73 people
- Sponsor
- Sinocelltech Ltd.
Cancer, Breast, Cancer, Lung
A Study of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of CBP-1019, a bi-specific ligand conjugated drugs in patients with advanced solid…
- Conditions
- Cancer, Breast, Cancer, Lung, Cancer of Pancreas, Cancer of Esophagus
- Trial name
- NCT05830097
- Testing
- CBP-1019
- Where
- 5 sites in United States, China
- Volunteers
- 260 people
- Sponsor
- Coherent Biopharma (Hefei) Co., Ltd.
Neoplasm Malignant
First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL
Primary Objective: To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in patients with relapsed and refractory multiple myeloma (RRMM) and relapsed and refractory non-Hodgkin lymphoma…
- Trial name
- NCT04401020
- Testing
- SAR442257
- Where
- 16 sites in United States, Czechia and 3 more
- Volunteers
- 47 people
- Sponsor
- Sanofi
Ulcerative Colitis
A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis
This is a study to learn if the experimental medicine (called PF-07054894) is safe, effective, and how it is processed in adult people with ulcers in the colon.
- Trial name
- NCT05549323
- Testing
- PF-07054894
- Where
- 17 sites in United States, Germany and 1 more
- Volunteers
- 44 people
- Sponsor
- Pfizer
Healthy Volunteers
First In Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-04427429 Administered Intravenously To Healthy Adult Volunteers
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers.
- Trial name
- NCT01011296
- Testing
- PF-04427429
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
First-in-human Trial With Single-dose C5a-neutralizing AON-D21 in Healthy Male Subjects
The main purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamic parameters after single ascending intravenous doses of AON-D21 in healthy male subjects.
- Trial name
- NCT05018403
- Testing
- Intravenous AON-D21
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Aptarion Biotech AG
Non-Small Cell Lung Cancer, Triple-negative Breast Cancer
Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC
Part 1of the study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of increasing doses of a vaccine-based immunotherapy regimen (VBIR-2) for patients with advanced or metastatic non-small cell lung…
- Trial name
- NCT03674827
- Testing
- PF-06936308
- Where
- 34 sites in United States
- Volunteers
- 36 people
- Sponsor
- Pfizer
Healthy
First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRS-080
Anticalins® are engineered human proteins that are able to bind specific target molecules. The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin and is intended for treatment of anemia of…
- Trial name
- NCT02340572
- Testing
- PRS-080#022-DP
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Pieris Pharmaceuticals GmbH
Non-Segmental Vitiligo
A Study of VC005 Tablets in Adolescent Subjects With Non-Segmental Vitiligo
This study is a multicenter, open-label, non-randomized study designed to evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of VC005 tablets in adolescent subjects with Non-Segmental Vitiligo
- Trial name
- NCT07828639
- Testing
- VC005 tablets
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Jiangsu vcare pharmaceutical technology co., LTD
Advanced Solid Tumors Cancer
First-In-Human Study of KHN922 for Injection
A Phase 1/2 Study of KHN922 for Injection to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity in Patients with Advanced Solid Tumors
- Trial name
- NCT07514975
- Testing
- KHN922 for injection
- Where
- China
- Volunteers
- 276 people
- Sponsor
- Chengdu Kanghong Biotech Co., Ltd.
Type 2 Diabetes Mellitus
A Study to Test the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK1006 (MK-1006-002)(COMPLETED)
This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of MK1006
- Trial name
- NCT00757601
- Testing
- MK1006
- Volunteers
- 25 people
- Sponsor
- Merck Sharp & Dohme LLC
Atopic Dermatitis
To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis
The purpose of this study is to determine the effect of GBR 830 on biomarkers in atopic dermatitis to enable further studies in this indication.
- Trial name
- NCT02683928
- Testing
- GBR 830
- Where
- 17 sites in United States, Canada
- Volunteers
- 64 people
- Sponsor
- Ichnos Sciences SA
Staphylococcal Sepsis
Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity Study in VLBW Neonates of BSYX-A110
The purpose of this study is to evaluate the safety (including tolerability), pharmacokinetics, pharmacodynamics and clinical activity of BSYX-A110 administered in a 3-dose regimen on Study Days 0, 7, and 14.
- Trial name
- N003 (NCT00631800)
- Testing
- Pagibaximab (formerly BSYX-A110)
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Biosynexus Incorporated
MELAS Syndrome, Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like Episodes (MELAS)
A Study to Assess TTI-0102 vs Placebo in MELAS Patients
This is a randomized, double-blind, placebo-controlled study. Prior to treatment, patients will undergo a screening visit. If eligible, each subject will return for a Day 1 visit and will receive their first dose of…
- Trial name
- NCT06644534
- Testing
- TTI-0102
- Where
- 2 sites in France, Netherlands
- Volunteers
- 9 people
- Sponsor
- Thiogenesis Therapeutics, Inc.
Hyperlipidemia
A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers
The purpose of this study is to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR) pitavastatin in healthy adult volunteers.
- Trial name
- NCT02634034
- Testing
- A: NK-104-CR 8 mg, B: Pitavastatin IR 4 mg, C: Pitavastatin IR 8 mg
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Kowa Research Institute, Inc.
Type 2 Diabetes
A Study of ZT002 Injection in Adult Chinese Subjects With Type 2 Diabetes Mellitus (T2DM)
This study will comprise a randomized, double blind, placebo controlled, multiple ascending dose, safety, tolerability and pharmacokinetic study of ZT002 in subjects with type 2 diabetes mellitus (T2DM).
- Trial name
- NCT07065032
- Testing
- ZT002 Injection
- Where
- China
- Volunteers
- 27 people
- Sponsor
- Beijing QL Biopharmaceutical Co.,Ltd
Polycythemia Vera
A Phase 1 Study of XL019 in Adults With Polycythemia Vera
The purpose of this study is to evaluate the safety and tolerability of the JAK2 inhibitor XL019 administered orally in adults with Polycythemia Vera.
- Trial name
- NCT00595829
- Testing
- XL019
- Where
- 5 sites in United States
- Volunteers
- 3 people
- Sponsor
- Exelixis
Obese or Overweight Healthy Volunteers, Type 2 Diabetes Mellitus (T2DM)
A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
The purpose of this study is to: evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the single-dose PK of ALN-4324 evaluate the efficacy, safety, tolerability, PK…
- Trial name
- NCT06845202
- Testing
- ALN-4324
- Where
- 22 sites in United States, Argentina and 4 more
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Overweight and Obesity
A Phase I Study of GZR18 Injection in Obese/Overweight Subjects
This is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study. A sequential design is used in this trial with a single dose escalation climb test, to investigate the safety, tolerability, and…
- Trial name
- NCT06548945
- Testing
- GZR18
- Where
- China
- Volunteers
- 16 people
- Sponsor
- Gan and Lee Pharmaceuticals, USA
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