Clinical trials: Pharmacodynamics
Paroxysmal Nocturnal Hemoglobinuria
Dose Escalation of BCX10013 in Participants with Paroxysmal Nocturnal Hemoglobinuria (PNH)
This is a multicenter, open-label, intra-subject, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and therapeutic potential of BCX10013 in participants with PNH.
- Trial name
- NCT06100900
- Testing
- BCX10013
- Where
- 4 sites in Malaysia, South Africa
- Volunteers
- 8 people
- Sponsor
- BioCryst Pharmaceuticals
Uterine Leiomyomata (Fibroids)
Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PRA-027 in Japanese Postmenopausal Women
The primary purpose of this study is to assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in Japanese postmenopausal women.
- Trial name
- NCT00826436
- Where
- Japan
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Ulcerative Colitis, Crohn's Disease
A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)
This is a randomized, observer-blinded, placebo-controlled study to evaluate safety, tolerability, immunogenicity, and pharmacokinetics of repeat dosing of intravenous (IV) UTTR1147A.
- Trial name
- NCT02749630
- Testing
- UTTR1147A
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Healthy
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants
The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of JNJ61803534 in healthy participants after administration of single ascending oral doses of JNJ-61803534 (Part 1) and multiple ascending…
- Trial name
- NCT03139500
- Testing
- JNJ-61803534, Midazolam
- Where
- Belgium
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
NF1 Mutation, Neurofibroma Plexiform
PAS-004 in Adults Who Have Neurofibromatosis Type 1 With Plexiform Neurofibromas
The main purpose of this clinical trial is to test PAS-004 in people with at least one symptomatic plexiform neurofibroma due to Neurofibromatosis Type 1 (NF1).
- Conditions
- NF1 Mutation, Neurofibroma Plexiform, Neurofibroma, Plexiform, Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs)
- Trial name
- NCT06961565
- Testing
- PAS-004 Tablets, PAS-004 Capsule
- Where
- 5 sites in United States, Australia and 1 more
- Volunteers
- 56 people
- Sponsor
- Pasithea Therapeutics Corp.
Healthy
Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male Volunteers
The primary objective of this trial is to investigate the safety and tolerability of BI 456906 in healthy subjects following single rising doses.
- Trial name
- NCT03175211
- Testing
- BI 456906
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Subjects, Pharmacokinetics of ASP3652
A Study to Assess the Safety, Tolerability, and Effects in and on the Body of Healthy Young and Elderly Male and Female Subjects of Ascending Multiple Oral Doses of ASP3652
The study investigates how safe ASP3652 is and how well it is tolerated when taken as multiple doses. The study also assesses how quickly and to what extent it is absorbed and eliminated from the body.
- Conditions
- Healthy Subjects, Pharmacokinetics of ASP3652, Pharmacodynamics of ASP3652
- Trial name
- NCT02243657
- Testing
- ASP3652
- Where
- Netherlands
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Europe B.V.
Chronic Kidney Injury
Oral CXA-10 Study in Healthy Volunteers
This will be the first-in-human (FIH) study with the oral formulation of CXA-10. The main purpose of this trial is to demonstrate the safety, tolerability and pharmacokinetics (PK) of CXA-10 and its metabolite(s) administered as…
- Trial name
- NCT02313064
- Testing
- CXA-10
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Complexa, Inc.
Health Volunteer
Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RSS0343 Tablets in Healthy Subjects After Single and Multiple Oral Administration and the Effect of Food on the Pharmacokinetics of RSS0343
To evaluate the safety and tolerability of RSS0343 tablets in healthy subjects after single and multiple oral administration
- Trial name
- NCT07101965
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy
BT-600 Single and Multiple Ascending Oral Doses in Healthy Adult Subjects
This is a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BT-600 when administered in single and multiple ascending doses to…
- Trial name
- NCT06275464
- Testing
- BT-600
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Biora Therapeutics, Inc.
TTR-mediated Amyloidosis
Safety and Tolerability of Patisiran (ALN-TTR02) in Transthyretin (TTR) Amyloidosis
This was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).
- Trial name
- NCT01617967
- Testing
- Patisiran
- Where
- 10 sites in United States, Brazil and 5 more
- Volunteers
- 29 people
- Sponsor
- Alnylam Pharmaceuticals
Accelerated Intimal Hyperplasia
Single Ascending Dose (BMS-813160) Study
The primary purpose of this study is to evaluate the safety and tolerability of single oral doses of BMS-813160 in healthy subjects
- Trial name
- NCT01049165
- Testing
- BMS-813160, [14C] BMS-813160
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Subjects
A Study of HS-10501 Tablets in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single dose and multiple dose of HS-10501 tables in healthy subjects.
- Trial name
- NCT06359600
- Testing
- HS-10501 tablet
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Advanced Unresectable Solid Tumors, BRAF-mutated Tumors
A Study of FORE8394 as a Single Agent in Patients With Advanced Unresectable Solid Tumors
The objective of this study is to determine the safety, pharmacokinetics, maximum tolerated dose/recommended Phase 2 dose, and efficacy of FORE8394.
- Trial name
- NCT02428712
- Testing
- FORE8394
- Where
- 13 sites in United States
- Volunteers
- 113 people
- Sponsor
- Fore Biotherapeutics
Healthy
A Multiple-Dose, Open-Label, Phase 1, Pharmacokinetic, Pharmacodynamic, and Safety Study of Avonex® in Chinese Healthy Volunteer Subjects
Rationale for the Study: The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Avonex in Chinese healthy volunteer subjects.
- Trial name
- NCT01416207
- Testing
- Avonex
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Biogen
Hypertension
A Study to Identify an Optimal Dose of QCZ484 in Mild to Moderate Hypertensive Patients
The purpose of this study is to evaluate the efficacy, safety and tolerability of QCZ484 or placebo, given subcutaneously, every 6 months, at different dose levels in patients with mild to moderate hypertension
- Trial name
- NCT06857955
- Testing
- Saline, QCZ484
- Where
- 72 sites in United States, Japan and 1 more
- Volunteers
- 396 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Participants Study
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of QLS2312 Injection
This study is a first-in-human Phase 1 clinical study conducted in healthy adult participants in China to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of QLS2312 Injection after single…
- Trial name
- NCT07861581
- Testing
- QLS2312 Injection
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTD
Familial ATTR-CM (ATTRm-CM, or FAC), Wild-type ATTR-CM (ATTRwt-CM)
Study of AG10 in Amyloid Cardiomyopathy
This prospective, randomized, multicenter, double-blind, parallel group, placebo-controlled, dose-ranging study will evaluate the safety, tolerability, PK (Pharmacokinetic) and PD (Pharmacodynamic) of AG10 compared to placebo…
- Trial name
- NCT03458130
- Testing
- AG10
- Where
- 13 sites in United States
- Volunteers
- 49 people
- Sponsor
- Eidos Therapeutics, a BridgeBio company
Healthy Volunteers
Adult Healthy Volunteers Study to Evaluate ALPN-101 Safety
This study is testing the safety, tolerability, pharmacokinetics (PK--the amount of study drug in the blood), pharmacodynamics (PD), how the study drug affects the body) and immunogenicity (how the study drug affects the immune…
- Trial name
- NCT03748836
- Testing
- ALPN-101
- Where
- Australia
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Alpine Immune Sciences, Inc.
Neoplasms
A Study Of PF-00299804 In Patients In Japan With Advanced Malignant Solid Tumors
To evaluate safety and tolerability of PF-00299804 in Japanese patients with advanced malignant solid tumors at doses up to the clinically recommended phase 2 dose in non-Japanese studies.
- Trial name
- NCT00783328
- Testing
- PF-00299804
- Where
- Japan
- Volunteers
- 13 people
- Sponsor
- Pfizer
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