Clinical trials: Safety and Pharmacokinetics
Chronic Hepatitis D
Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of RBD1016 in Participants With Chronic Hepatitis D
The goal of this clinical trial is to learn if drug RBD1016 works to treat chronic hepatitis D virus infection in adults. It will also learn about the safety of drug RBD1016.
- Trial name
- NCT06649266
- Testing
- RBD1016
- Where
- 2 sites in Sweden
- Volunteers
- 14 people
- Sponsor
- Ribocure Pharmaceuticals AB
Advanced Solid Tumor, Hematological Malignancy
An Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of YY201 in Patients With Advanced Solid Tumors and Hematological Malignancies
This is a multicenter, open-label, phase I clinical study of YY201 in the patients with relapsed/refractory lymphomas and relapsed/refractory large granular lymphocytic leukemia who failed or cannot tolerate standard treatment.
- Trial name
- NCT06225856
- Testing
- YY201
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Shanghai Yuyao Biotech Co., Ltd.
Hepatitis C
Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone
Otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered BI 201335 daily to…
- Trial name
- NCT01637922
- Testing
- BI 201335
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Boehringer Ingelheim
Solid Tumors
Dose Escalation Study of the Safety and Pharmacokinetics of ME-344 Single Agent for Refractory Solid Tumors
The purpose of this study is to determine the tolerability of ME-344, find the maximum tolerated dose, and the safety profile in patients with refractory solid tumors.
- Trial name
- ME-344-001 (NCT01544322)
- Testing
- ME-344
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- MEI Pharma, Inc.
Prevention of Infection With HIV-1
Safety Study of Ibalizumab Subcutaneous Injection in Healthy Volunteers
The is a blinded safety study of ibalizumab given by subcutaneous injection in sequentially increasing dose-groups of at-risk, HIV-negative, healthy volunteers.
- Trial name
- TMB-108 (NCT01292174)
- Where
- 6 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- TaiMed Biologics Inc.
Advanced and/or Metastatic Solid Tumours
Study of CB307 in Patients With Advanced and/or Metastatic PSMA-positive Tumours.
FIH, Phase 1, open-label, multi centre study of CB307, a trispecific Humabody® T-cell enhancer, in patients with advanced and/or metastatic PSMA+ solid tumours to assess safety and tolerability to determine MTD and preliminary…
- Trial name
- POTENTIA (NCT04839991)
- Testing
- CB307
- Where
- 20 sites in United States, Netherlands and 2 more
- Volunteers
- 70 people
- Sponsor
- Crescendo Biologics Ltd.
Healthy
A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants
The purpose of this study is to evaluate the safety, acceptability, pharmacokinetics (what the body does to the medication), and ex vivo (tested outside the body) pharmacodynamics (what the medication does to the body) of TMC278…
- Trial name
- NCT01656018
- Testing
- TMC278, Long acting (LA)
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis, Crohn's Disease
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin…
- Trial name
- NCT06100289
- Testing
- Vedolizumab IV, Vedolizumab SC
- Where
- 54 sites in United States, Belgium and 14 more
- Volunteers
- 70 people
- Sponsor
- Takeda
Osteoporosis, Postmenopausal
A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants
The purpose(s) of this study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given in multiple doses, subcutaneously (SC) (by inserting a needle just under…
- Trial name
- NCT02109042
- Testing
- Blosozumab
- Where
- 2 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Bronchopulmonary Dysplasia (BPD), Premature Births
PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia
The purpose of the study is to learn how safe montelukast may be in premature infants at significant risk for Bronchopulmonary Dysplasia (BPD) and to determine how much and how quickly montelukast moves from the stomach into the…
- Conditions
- Bronchopulmonary Dysplasia (BPD), Premature Births, Critical Illness
- Trial name
- PRISM (NCT07101640)
- Testing
- montelukast 4 mg granule
- Where
- 5 sites in United States
- Volunteers
- 28 people
- Sponsor
- Duke University
End-Stage Renal Disease, End-Stage Kidney Disease
A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011)
This was intended as a three-part study of MK-2060 in participants with chronic and/or end-stage kidney disease (Parts 2 and 3 were not initiated due to reasons not related to safety).
- Conditions
- End-Stage Renal Disease, End-Stage Kidney Disease, Kidney Failure, Chronic
- Trial name
- NCT05656040
- Testing
- MK-2060
- Where
- 4 sites in United States
- Volunteers
- 14 people
- Sponsor
- Merck Sharp & Dohme LLC
Total Knee Arthroplasty
Study of Local Administration of DepoTXA for Reduced Postsurgical Bleeding in Subjects Undergoing TKA
This is a Phase 2, randomized, single-blind, active-controlled dose-ranging study in subjects scheduled to undergo total knee arthroplasty (TKA).
- Trial name
- NCT02922582
- Testing
- DepoTXA, Tranexamic Acid
- Where
- 5 sites in United States
- Volunteers
- 16 people
- Sponsor
- Pacira Pharmaceuticals, Inc
COPD
Crossover Study to Assess the Efficacy of PT003 With and Without a Valved Holding Chamber in Subjects With Moderate to Severe COPD
This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to Severe COPD with and without a Valved Holding Chamber.
- Trial name
- NCT02454959
- Testing
- GFF MDI (PT003) with Aerochamber, GFF MDI (PT003) without Aerochamber
- Where
- 6 sites in United States
- Volunteers
- 80 people
- Sponsor
- Pearl Therapeutics, Inc.
Advanced Malignant Solid Tumors
A Study of HMPL-295S1 in Patients With Advanced Malignant Solid Tumors
The objective of this study is to evaluate the safety, tolerability and PK profile of HMPL-295S1 and determine MTD and/or RP2D in patients with advanced malignant solid tumor.
- Trial name
- NCT04908046
- Testing
- HMPL-295S1 with dose escalation stage of 5mg up to 200mg, then expansion stage with recommended dose of therapeutic cycle of 28 days .
- Where
- China
- Volunteers
- 47 people
- Sponsor
- Hutchmed
Healthy Volunteers
SAD and MAD Study of FTX-101 in Healthy Male Subjects
This is a Phase 1, first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled study in healthy male subjects.
- Trial name
- NCT06617546
- Testing
- FTX-101
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Find Therapeutics
Healthy
Study to Evaluate Safety, Tolerability, PK and PD of ALXN1007 in Healthy Subjects
The purpose of the study is to evaluate the safety, tolerability, PK and PD of a single-dose of ALXN1007 in healthy volunteers.
- Trial name
- NCT01454986
- Testing
- ALXN1007
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Asthma
Study of Multiple Doses of PRS-060 Administered by Oral Inhalation in Subjects With Mild Asthma
Study of Multiple Doses of PRS-060 Administered by Oral Inhalation in Subjects with Mild Asthma
- Trial name
- NCT03574805
- Testing
- PRS-060
- Where
- 4 sites in Australia
- Volunteers
- 76 people
- Sponsor
- Pieris Australia Pty Ltd
Growth Hormone Deficiency
Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone Deficiency
The purpose of this study is to evaluate the pharmacokinetics of Syntropin (a human growth hormone) and to determine the serum concentration of IGF-1 after Syntropin injection.
- Trial name
- NCT00489294
- Testing
- Syntropin
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Phage Pharmaceuticals, Inc.
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Multiple Ascending Dose Study of MK-5160 in Participants With Type 1 and Type 2 Diabetes Mellitus (MK-5160-002)
This is a randomized, active- and placebo-controlled, double-blind trial of MK-5160 in participants with Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM). This is a two-part trial, with three panels per part.
- Trial name
- NCT03095651
- Testing
- MK-5160 16 nmol/kg, MK-5160 32 nmol/kg, MK-5160 64 nmol/kg
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248
This is a First in Human (FIH), double-blinded, parallel-group, randomised, placebo-controlled study designed to evaluate the safety, tolerability, PK and PD of single and multiple ascending oral doses of GS-248 in healthy…
- Trial name
- NCT04036227
- Testing
- GS-248
- Where
- Sweden
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Gesynta Pharma AB
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