Clinical trials: Phase 1
Age-Related Macular Degeneration
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
The main objective of the study is evaluation of the safety and tolerability of OpRegen - Human embryonic stem cell-derived retinal pigment epithelial (RPE) cells.
- Trial name
- NCT02286089
- Testing
- OpRegen
- Where
- 7 sites in United States, Israel
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Atopic Dermatitis
A Study to Assess Bioavailability of Rocatinlimab (AMG 451) Vial and Prefilled Syringe in Healthy Participants
The primary objective of the study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) dose in a vial compared to a prefilled syringe in healthy participants.
- Trial name
- NCT06268860
- Testing
- Rocatinlimab vial injection, Rocatinlimab prefilled syringe
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Amgen
Advanced Solid Tumors
Study of AMG 256 in Adult Subjects With Advanced Solid Tumors
To evaluate the safety and tolerability of AMG 256 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
- Trial name
- NCT04362748
- Testing
- AMG 256
- Where
- 11 sites in United States, Australia and 2 more
- Volunteers
- 34 people
- Sponsor
- Amgen
Healthy Participants
Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS Glargine (G), United States (US)-Lantus®, and European Union (EU)-Lantus®
Single-dose, double-blind, randomized, three-period, three-treatment, six-sequence, crossover study to demonstrate pharmacokinetic and pharmacodynamic similarity between NKF-INS Glargine (G), United States (US)-Lantus®, and…
- Trial name
- NCT06627478
- Testing
- NKF-INS(G), US-Lantus®, EU-Lantus®
- Where
- South Africa
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Xentria, Inc.
Solid Tumors
A Study of E7130 in Participants With Solid Tumors
The primary objective of this study is to evaluate the tolerability and safety profile of E7130 in participants with solid tumors.
- Trial name
- NCT03444701
- Testing
- E7130
- Where
- 9 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Eisai Co., Ltd.
Solid Neoplasms
A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors
The main aim of this study is to check if people with advanced solid tumors have side effects from dazostinag, and to check how much dazostinag they can receive without getting significant side effects from it when given alone…
- Trial name
- iintune-1 (NCT04420884)
- Testing
- Dazostinag, Pembrolizumab, Platinum
- Where
- 62 sites in United States, Austria and 9 more
- Volunteers
- 248 people
- Sponsor
- Takeda
Non Hodgkins Lymphoma, Diffuse Large B-cell Lymphoma
To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)
This is an open-label, multicenter study to evaluate safety and tolerability, determine the RP2Ds of tafasitamab alone in Japanese participants with R/R NHL, or to evaluate efficacy and safety of tafasitamab in combination with…
- Trial name
- J-MIND (NCT04661007)
- Testing
- tafasitamab, lenalidomide, parsaclisib
- Where
- 23 sites in Japan
- Volunteers
- 72 people
- Sponsor
- Incyte Biosciences Japan GK
Tumors
Phase 1 Study of E7090 in Subjects With Solid Tumor
This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be conducted in 2 parts: 1. Part 1 will be the dose escalation portion of this study to determine the maximum tolerated dose in subjects…
- Trial name
- NCT02275910
- Testing
- E7090
- Where
- 18 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Eisai Co., Ltd.
Healthy, Renal Impairment
A Clinical Study of Enlicitide in Participants With Severe Renal Impairment (MK-0616-032)
Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood.
- Trial name
- NCT06643377
- Testing
- Enlicitide
- Where
- 5 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Epilepsy
Pharmacokinetics Study of VALTOCO® in Pediatric Subjects With Epilepsy
This is a Phase 1/2a, open-label, single-dose, PK study of VALTOCO with open-label safety period in pediatric epilepsy subjects age 2 to 5 years.
- Trial name
- NCT05076838
- Testing
- Diazepam Nasal Spray [Valtoco]
- Where
- 13 sites in United States
- Volunteers
- 36 people
- Sponsor
- Neurelis, Inc.
Healthy, Obesity, Metabolically
A First in Human (FIH) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DR10624
DR10624 is an Fc fusion protein tri-agonist with balanced glucagon-like peptide-1 receptor (GLP-1R)/glucagon receptor (GCGR)/ fibroblast growth factor 21 receptor (FGF21R) agonizing activities.
- Trial name
- NCT05378893
- Testing
- DR10624 for injection
- Where
- New Zealand
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Zhejiang Doer Biologics Co., Ltd.
Healthy Participants
A Drug-Drug Interaction Study Evaluating the Perpetrator Potential of DC-806 on Cocktails of CYP450 Enzyme and Transporter Substrates in Healthy Participants
The main objective of this study is to assess the effect of DC-806 on the pharmacokinetics (PK) of cytochrome 3A4 (CYP3A4) substrate, midazolam and its active metabolite, 1-hydroxymidazolam, cytochrome 2C8 (CYP2C8) substrate…
- Trial name
- NCT06092931
- Testing
- DC-806, Midazolam, Repaglinide
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Acute Myeloid Leukemia
A Study to Investigate Natural Killer Cell Engager (SAR443579) With Different Agents in Participants With Hematological Malignancies
This was a parallel, Phase 1/Phase 2, randomized, open label, multi-cohort, multi-center study assessing the safety, tolerability and preliminary efficacy of SAR443579 with different agents for treatment in adolescent and/or…
- Trial name
- NCT06508489
- Testing
- SAR443579, venetoclax, azacitidine
- Where
- 7 sites in United States, Australia
- Volunteers
- 7 people
- Sponsor
- Sanofi
Colorectal Cancer Metastatic
EO4010 in Previously Treated Metastatic Colorectal Carcinoma
Open-label multicenter study
- Trial name
- AUDREY (NCT05589597)
- Testing
- EO4010
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 25 people
- Sponsor
- Enterome
Healthy Volunteers
A Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Participants
The primary objective of this study was to assess the effect of a cytochrome P450 3A4 (CYP3A4) inhibitor (itraconazole) and CYP3A4 inducer (carbamazepine) on the single dose pharmacokinetics (PK) of DC-806 coadministered with…
- Trial name
- NCT05994807
- Testing
- DC-806, Itraconazole, Carbamazepine
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
Renal Impairment
A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics and Safety of VIR-2218
The rationale of this study is to evaluate the impact of renal function on the PK, safety, and tolerability of VIR-2218 in participants with normal renal function and participants with varying degrees of renal dysfunction who are…
- Trial name
- NCT05844228
- Testing
- VIR-2218
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.
Severe Hemophilia A
Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A
This Phase 1/2 study will be a dose escalation study in adults in 5 cohorts (named cohorts 1, 2, 3, 5 and 6), with the main purpose to assess the safety of subcutaneous injection of OCTA101 (a human-cl rhFVIII and recombinant…
- Trial name
- NCT04046848
- Testing
- OCTA101
- Where
- Bulgaria
- Volunteers
- 36 people
- Sponsor
- Octapharma
Hepatitis B
Study of GSK3965193 in Healthy Participants and Participants Living With Chronic Hepatitis B Infection
This Phase 1/2a multiple part study is a first time-in-human (FTIH) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of single (Part 1) and repeat doses (Part 2) of GSK3965193 in healthy…
- Trial name
- NCT05330455
- Testing
- GSK3965193, Bepirovirsen
- Where
- 14 sites in Canada, France and 4 more
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Carcinoma, Hepatocellular
A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer
The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular…
- Trial name
- RELATIVITY-106 (NCT05337137)
- Testing
- Relatlimab, Nivolumab, Bevacizumab
- Where
- 61 sites in United States, Australia and 13 more
- Volunteers
- 82 people
- Sponsor
- Bristol-Myers Squibb
Healthy, Dermatitis, Atopic
A Study of LY3844583 in Healthy Participants and Participants With Atopic Dermatitis
The main purpose of this study is to evaluate the safety and tolerability of LY3844583 in healthy participants and participants with atopic dermatitis (AtD).
- Trial name
- NCT05486208
- Testing
- LY3844583
- Where
- 3 sites in United States, Japan
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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