Clinical trials: Safety and Pharmacokinetics
Relapsed Diffuse Large B-cell Lymphoma, Refractory Diffuse Large B-cell Lymphoma
Treatment of Relapsed or Refractory Diffuse Large B Cell Lymphoma With Ociperlimab (BGB-A1217) in Combination With Tislelizumab (BGB-A317) or Rituximab
The primary purpose of this study is to assess the safety and tolerability of ociperlimab (BGB-A1217) in combination with tislelizumab (BGB-A317) or rituximab in participants with relapsed or refractory (R/R) diffuse large B cell…
- Trial name
- NCT05267054
- Testing
- Ociperlimab, Tislelizumab, Rituximab
- Where
- 19 sites in China
- Volunteers
- 53 people
- Sponsor
- BeiGene
Healthy
Safety, Tolerability, Pharmacokinetics of Intravenous FL058 and Meropenem in Healthy Subjects(SAD/MAD)
Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of FL058 and Meropenem Alone and in Combination following Single and Multiple Doses in Healthy Adult Subjects.
- Trial name
- NCT05058105
- Testing
- FL058 500mg and Meropenem 1000mg（ IV 120min）, FL058 1000mg（ IV 120min）, Meropenem 1000 mg （ IV 120min）
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Healthy
A Study of HM11260C in Healthy Male Subject
Study Design: Randomized, double-blind, placebo-controlled, escalating single-dose design. Five ascending dose cohorts are planned.
- Trial name
- NCT01093729
- Testing
- HM11260C
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Advanced Cancer, Advanced Solid Tumors
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Antitumor Activity of ALK201 in Participants With Advanced Solid Tumors
This is a first-in-human (FIH), open-label, multicenter dose escalation and expansion study of ALK201. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of ALK201 as…
- Trial name
- NCT06656390
- Testing
- ALK201
- Where
- 38 sites in United States, Australia and 1 more
- Volunteers
- 202 people
- Sponsor
- Shanghai Allink Biotherapeutics Co., Ltd.
HIV/AIDS
A Phase 1/2a Study of PGT121, VRC07-523LS and PGDM1400 Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults
This is a Phase 1/2a open label study to evaluate the safety, tolerability, pharmacokinetics and anti-viral activity of PGT121, VRC07-523LS and PGDM1400 for HIV prevention and therapy.
- Trial name
- NCT03721510
- Testing
- PGT121 + VRC07-523LS, PGT121 + VRC07-523LS + PGDM1400
- Where
- 3 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
Ulcerative Colitis (UC)
The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC
This study will evaluate the efficacy and safety of 627 in patients with UC.
- Trial name
- NCT07507513
- Testing
- 627
- Where
- China
- Volunteers
- 288 people
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Renal Disease, End-Stage, Renal Insufficiency, Chronic
Bosutinib In Subjects With Renal Impairment
This is a two-staged study of a single dose of 200 mg of bosutinib given to subjects with renal impairment and matching healthy volunteers.
- Conditions
- Renal Disease, End-Stage, Renal Insufficiency, Chronic, Renal Insufficiency, Acute
- Trial name
- NCT01233882
- Testing
- Bosutinib
- Where
- 5 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pfizer
Colorectal Cancer, Breast Cancer
Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SNB-101(SN-38) in Patients With Tumors
SNB-101 is a novel nano-particle formulation of SN-38, the active metabolite of irinotecan(CPT-11). Study SNB101P01 is a multicenter, open-label, dose escalation, phase 1 study of SNB 101 with its active ingredient SN-38, in…
- Conditions
- Colorectal Cancer, Breast Cancer, Pancreas Cancer, Ovarian Cancer
- Trial name
- NCT04640480
- Testing
- SNB-101
- Where
- 3 sites in South Korea
- Volunteers
- 21 people
- Sponsor
- SN BioScience
Influenza
Safety, Tolerability, and PK of Escalating Doses of Flufirvitide-3 Dry Powder for Inhalation in Healthy Subjects
To evaluate the safety, tolerability and pharmacokinetics (PK) of single,and repeat escalating doses of FF-3 dry powder administered via inhalation in healthy adult subjects
- Trial name
- NCT01990846
- Testing
- Flufirvitide 3
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Autoimmune Technologies, LLC
Impaired Hepatic Function
Study of Aldafermin (NGM282) in Participants With Impaired Hepatic Function
This is an evaluation of Aldafermin (NGM282) in an open-label, single-dose and parallel group study in participants with Impaired Hepatic Function
- Trial name
- NCT04823702
- Testing
- Aldafermin
- Where
- 3 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- NGM Biopharmaceuticals, Inc
Pompe Disease
Study to Evaluate the Safety of AT2220 (Duvoglustat) in Pompe Disease
The main purpose of this study was to determine the safety and tolerability of 3 different doses of duvoglustat (AT2220) in participants affected by Pompe disease.
- Trial name
- NCT00688597
- Testing
- Duvoglustat
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Amicus Therapeutics
Safety After Oral Intake, Pharmacokinetics After Oral Intake
Oral Bioavailability and Bioactivity of Prenylflavonoids From Hops
The prenylflavonoids 6-prenylnaringenin (6-PN) and 8-prenylnaringenin (8-PN) are secondary plant substances, almost exclusively found in hops (Humulus lupulus).
- Conditions
- Safety After Oral Intake, Pharmacokinetics After Oral Intake, Immune Cells Activity
- Trial name
- NCT03140397
- Testing
- 6-prenylnaringenin, 8-prenylnaringenin
- Where
- 2 sites in Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- University of Hohenheim
Hypertension
Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension
Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension
- Trial name
- NCT00344110
- Testing
- Aliskiren
- Where
- Japan
- Volunteers
- 768 people
- Sponsor
- Novartis
COVID-19
Pharmacokinetics, Pharmacodynamics, and Safety of Single-dose Sotrovimab in High-risk Pediatric Participants With Mild to Moderate COVID-19
This Phase 2b study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of sotrovimab in pediatric participants from birth to less than (<)18 years old with mild-to-moderate Coronavirus Disease-2019…
- Trial name
- COMET-PACE (NCT05124210)
- Testing
- Sotrovimab
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- GlaxoSmithKline
Multiple Myeloma
A Study Evaluating Safety, Tolerability and Clinical Activity of FHND6091 in Patients With Multiple Myeloma
This is a phase I, first in human, single arm, open label study that will assess safety, tolerability and clinical activity of FHND6091 when taken orally on a weekly dosing schedule by patients with relapsed and refractory…
- Trial name
- NCT05271682
- Testing
- FHND6091
- Where
- 6 sites in China
- Volunteers
- 40 people
- Sponsor
- Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
Head and Neck Cancer, Liver Cancer
A Phase Ib Expansion Study Investigating the Safety, Efficacy, and Pharmacokinetics of Intravenous CUDC-101 in Subjects With Advanced Head and Neck, Gastric, Breast, Liver and Non-small Cell Lung Cancer Tumors
This is a phase Ib open label, expansion study of CUDC-101 in patients with advanced head and neck, gastric, breast, liver, and non-small cell lung cancer tumors.
- Conditions
- Head and Neck Cancer, Liver Cancer, Breast Cancer, Gastric Cancer
- Trial name
- NCT01171924
- Testing
- CUDC-101
- Where
- 7 sites in United States
- Volunteers
- 47 people
- Sponsor
- Curis, Inc.
HIV Infections With Multi Drug Resistant Virus
Safety and Pharmacokinetics Evaluation of Fostemsavir + (OBT) in HIV-1 Infected Children and Adolescents Who Are Failing Their cART and Have Dual- or Triple-class Antiretroviral Resistance
In the SHIELD study, the study sponsor seeks to assess safety, PK and antiviral activity for children and adolescents with dual or triple class resistance.
- Trial name
- NCT04648280
- Testing
- Fostemsavir
- Where
- 8 sites in United States, Brazil and 1 more
- Volunteers
- 60 people
- Sponsor
- PENTA Foundation
Type 1 Diabetes Mellitus
Pharmacologic Response and Safety of Inhaled Insulin in Type 1 Diabetes
The purpose of this study was to compare the pharmacokinetic (PK) response after inhaled insulin administration with 3 different inhalation regimens and with subcutaneous insulin administration.
- Trial name
- Samba-01 (NCT02713841)
- Testing
- inhaled human insulin (INH), sc insulin lispro (LIS)
- Volunteers
- 12 people
- Sponsor
- Dance Biopharm Inc.
Cognitive Disorders
Safety, Tolerability and Pharmacokinetics of GSK1034702 in Healthy Subjects
This is a First Time in Human Study to assess the safety, tolerability and pharmacokinetics of single doses of GSK1034702 in healthy subjects.
- Trial name
- NCT00743405
- Testing
- GSK1034702
- Where
- United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Non-alcoholic Steatohepatitis
Safety, Tolerability, and Pharmacokinetics of ACT500 in Healthy Adult Participants
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study, divided into two parts. The first part is a single-dose escalation study (Part1,SAD study phase), and the second part is a…
- Trial name
- NCT06716905
- Testing
- ACT500 tablets
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
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