Clinical trials: Pharmacodynamics
Hepatic Impairment
A Study About Fazirsiran in People With and Without Liver Problems
The main aim of this study is to learn how the body processes fazirsiran (pharmacokinetics [PK]) in people with mild, moderate, or severe liver problems, compared to people with normal liver function.
- Trial name
- NCT05891158
- Testing
- Fazirsiran
- Where
- 4 sites in Hungary, Slovakia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Takeda
Multiple Myeloma
A Study of MBS314 for Injectionin Participants With Relapsed/Refractory Multiple Myeloma.
This is a Phase I/II, multicenter, open-label, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of MBS314, a novel asymmetric…
- Trial name
- NCT07911748
- Testing
- MBS314 for Injection
- Volunteers
- 78 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
Healthy Male Subjects, Cardiovascular Disease
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Male Subjects
This is a phase I, randomised, single-blind, placebo-controlled, first-in-human (FIH) single and multiple ascending dose study consisting of two parts (Part A [SAD] and Part B [MAD]) to assess the safety, tolerability…
- Trial name
- NCT02632526
- Testing
- AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A), AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)
- Where
- United Kingdom
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Normal Healthy Subjects
Study to Evaluate HT-4253 in Healthy Subjects
The primary objectives of this study are to evaluate the safety and tolerability of HT-4253 when administered as single oral doses and multiple oral doses at escalating dose levels in healthy volunteer subjects.
- Trial name
- NCT06537817
- Testing
- HT-4253
- Where
- Australia
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Halia Therapeutics, Inc.
IPF
A Study to Evaluate the Safety, Tolerability, PK and PD of HNC1058
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of HNC1058 given to healthy subjects, compared to placebo.
- Trial name
- NCT05803850
- Testing
- HNC1058 Capsules
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Guangzhou Henovcom Bioscience Co. Ltd.
Advanced or Metastatic Solid Tumors
A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors
TAK-188 is a new medicine that targets a protein called CCR8, which is found on the surface of certain cells (Tregs) inside tumors. These cells can weaken the body's ability to fight cancer.
- Trial name
- NCT07205718
- Testing
- TAK-188
- Where
- 15 sites in United States
- Volunteers
- 273 people
- Sponsor
- Takeda
Advanced Prostate Cancer
Goserelin 10.8mg Injection in Treatment of Advanced Prostate Cancer
A two arm, multi centric, randomized, open label, parallel, two doses pharmacodynamics study in patients with advanced prostate cancer.
- Trial name
- NCT03936218
- Testing
- Inj. Goserelin (Test) Subcutaneously, Inj. Zoladex (Reference) Subcutaneously
- Where
- India
- Volunteers
- 94 people
- Sponsor
- Eurofarma Laboratorios S.A.
Osteoporosis, Postmenopausal
Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults
A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW031 and Prolia® in healthy adults.
- Trial name
- MW031 (NCT04798313)
- Testing
- MW031, Prolia®
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Diabetes Mellitus, Type 2
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CNTO 3649 in Healthy Adults and Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTO 3649 following a single dose in healthy adults and following multiple doses in patients with Type 2 Diabetes Mellitus.
- Trial name
- NCT00882726
- Testing
- CNTO 3649 IV (Healthy participants), CNTO 3649 SC (Healthy participants), CNTO 3649 SC (Diabetic patients)
- Where
- 3 sites in United States
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Centocor, Inc.
Non-alcoholic Fatty Liver Disease
Different Doses of BI 1467335 Compared to Placebo in Patients With Clinical Evidence of NASH
The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH.
- Trial name
- NCT03166735
- Testing
- BI 1467335
- Where
- 44 sites in United States, Belgium and 7 more
- Volunteers
- 114 people
- Sponsor
- Boehringer Ingelheim
Leukemia, Neoplasms
Open Dose Escalating Trial to Determine the Maximum Tolerated Dose in Paediatric Patients With Advanced Cancers for Whom no Therapy is Known
The present trial will be performed according to an open design to determine the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group…
- Trial name
- NCT01971476
- Testing
- volasertib
- Where
- 5 sites in Belgium, Czechia and 3 more
- Volunteers
- 22 people
- Sponsor
- Boehringer Ingelheim
Osteoporosis
A Safety, Tolerability and Pharmacodynamics Study of ACE-011 (ActRIIA-IgG1) in Healthy Postmenopausal Women
This is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ACE-011 in healthy postmenopausal women.
- Trial name
- NCT00709540
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Healthy
A Study to Learn How Different Amounts of the Study Medicine Called PF-07314470 Are Tolerated and Act in the Body in Healthy Adults
The purpose of this clinical trial is to learn if the study medicine (called PF-07314470) is safe and how it gets in and out of the body in healthy people.
- Trial name
- NCT06821750
- Testing
- PF-07314470
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pfizer
Homocystinuria Due to Cystathionine Beta-Synthase Deficiency
A Multiple Ascending Dose Study of ACN00177 (Pegtarviliase) in Subjects With CBS Deficiency
The purpose of this study is to evaluate the safety and tolerability of pegtarviliase in approximately 36 subjects with homocystinuria due to CBS deficiency.
- Trial name
- NCT05154890
- Testing
- Pegtarviliase IV, Pegtarviliase SC
- Where
- 9 sites in United States, Australia and 1 more
- Volunteers
- 13 people
- Sponsor
- Aeglea Biotherapeutics
Solid Tumor, Lymphoma
A Study of IMC-002 in Subjects With Metastatic or Locally Advanced Solid Tumors and Relapsed or Refractory Lymphomas
This is the first-in-human, Phase I, open-label, multiple-ascending dose study to investigate the safety, tolerability, PK, PharmDyn, and clinical activity of IMC-002 in subjects with metastatic or locally advanced solid tumors…
- Trial name
- NCT04306224
- Testing
- IMC-002
- Where
- 4 sites in United States, South Korea
- Volunteers
- 12 people
- Sponsor
- ImmuneOncia Therapeutics Inc.
Solid Tumor, Gastric Cancer
SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors
A Phase I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of SON-DP in Subjects with Advanced Solid Tumors
- Conditions
- Solid Tumor, Gastric Cancer, Liver Cancer
- Trial name
- NCT06873659
- Testing
- SON-DP
- Where
- 11 sites in China
- Volunteers
- 96 people
- Sponsor
- Qurgen Inc.
Hypertension
A Clinical Trial to Evaluate Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan/Hydrochlorothiazide
A 2-Week, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy, Tolerability, and Pharmacokinetic-Pharmacodynamic Relationship of Fimasartan in Combination with Hydrochlorothiazide in Patients…
- Trial name
- NCT02222480
- Testing
- Fimasartan, Hydrochlorothiazide
- Where
- South Korea
- Volunteers
- 103 people
- Sponsor
- Boryung Pharmaceutical Co., Ltd
Diabetes, Diabetes Mellitus, Type 1
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp When Administered as a Bolus in a Continuous Subcutaneous Infusion Regimen in Subjects With Type 1 Diabetes
This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of FIAsp…
- Trial name
- NCT01992588
- Testing
- Faster-acting insulin aspart, insulin aspart
- Where
- Germany
- Volunteers
- 48 people
- Sponsor
- Novo Nordisk A/S
Asthma
A Single Dose PD & PK Study With Two Formulations of Abediterol in Patients With Asthma
The purpose of this study is to investigate the pharmacodynamics of single doses of abediterol given by 2 different devices in participants with asthma.
- Trial name
- NCT02777827
- Testing
- Abediterol 0.156 μg, Abediterol 2.5 μg, Abediterol 0.05 μg
- Where
- 4 sites in Germany
- Volunteers
- 30 people
- Sponsor
- AstraZeneca
Renal Impairment, Renal Insufficiency
PK and PD Study of IDN-6556 in Subjects With Severe Renal Impairment and Matched Healthy Volunteers
This is an open-label, parallel-group study to compare the pharmacokinetics and pharmacodynamics of IDN-6556 following a single 50 mg oral dose of IDN-6556 in subjects with severe renal impairment and matched healthy volunteers…
- Conditions
- Renal Impairment, Renal Insufficiency, Kidney Disease, Kidney Diseases
- Trial name
- NCT02039817
- Testing
- IDN-6556
- Where
- 2 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Conatus Pharmaceuticals Inc.
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