Clinical trials: First in Man Study to Evaluate Initial Safety
Netherton Syndrome
A Study to Evaluate Topically Applied SXR1096 Cream in Patients With Netherton Syndrome
In this phase I/II trial a topical skin cream with the active substance SXR1096 will be tested in patients with Netherton syndroms, a rare inflammatory skin disease.
- Trial name
- NCT05211830
- Testing
- SXR1096 cream
- Where
- 5 sites in Austria, France and 2 more
- Volunteers
- 9 people
- Sponsor
- Sixera Pharma
Respiratory Syncytial Virus Infections, Respiratory Syncytial Virus (RSV)
Phase I, First-In Human Study to Evaluate Safety and Tolerability of EuRSV in Healthy Adults Aged Between 19 Years and 80 Years
Phase 1 clinical trial to evaluate the safety of RSV-1 and RSV-2 vaccines in healthy adults aged 19 to 80 years who have voluntarily given written consent to participate in this study.
- Trial name
- EuRSV (NCT06216093)
- Testing
- EuRSV
- Where
- South Korea
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- EuBiologics Co.,Ltd
Renal Cell Carcinoma
Sequential Study to Treat Renal Cell Carcinoma
Primary: To evaluate if progression-free survival from first treatment to progression or death during second-line therapy (total PFS) of sorafenib followed by sunitinib is superior compared to sunitinib followed by sorafenib.
- Trial name
- NCT00732914
- Testing
- Sunitinib (Sutent), Sorafenib (Nexavar)
- Where
- Germany
- Volunteers
- 272 people
- Sponsor
- Sponsor GmbH
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability, and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Participants
The primary purpose of the study is to evaluate the safety and tolerability of EA1080 following single and multiple ascending oral doses in healthy Caucasian and Japanese male participants.
- Trial name
- NCT04223960
- Testing
- EA1080
- Where
- United Kingdom
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- EA Pharma Co., Ltd.
Leukemia, Leukemia, Myeloid
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome…
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Preleukemia
- Trial name
- NCT06501196
- Testing
- BH-30236, Venetoclax
- Where
- 13 sites in United States
- Volunteers
- 170 people
- Sponsor
- BlossomHill Therapeutics
Healthy, Volunteers
A Study Intended to Evaluate Safety, Tolerability and Pharmacokinetics (PK) Parameters of BL-1021
The purpose of this study is to test the safety, tolerability and pharmacokinetics of BL-1021 in healthy volunteers. Subsequent clinical studies will be designed to test the safety and efficacy of BL-1021 in patients with…
- Trial name
- NCT01121380
- Testing
- BL-1021, 1021
- Where
- Israel
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- BioLineRx, Ltd.
Cognitive Disorders
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-G3031 in Healthy Subjects
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of SUVN-G3031 in healthy male subjects following single or multiple ascending doses.
- Trial name
- NCT02342041
- Testing
- SUVN-G3031
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Suven Life Sciences Limited
Osteopenia
A First-in-human Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women
The primary objective of this study is to determine the safety and tolerability of AMG 167 following a single dose subcutaneous (SC) or intravenous (IV) administration in healthy men and postmenopausal women.
- Trial name
- NCT00902356
- Testing
- AMG 167
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy
SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of the investigational drug TD-1473 compared to placebo in healthy subjects.
- Trial name
- NCT02657122
- Testing
- TD-1473 for SAD, TD-1473 for MAD
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Dry Age-related Macular Degeneration, Geographic Atrophy
First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration
The study is designed to identify the maximum tolerated dose (MTD) for intravitreal (IVT) administration of GEM103 in subjects with geographic atrophy (GA) secondary to dry AMD.
- Conditions
- Dry Age-related Macular Degeneration, Geographic Atrophy, Macular Degeneration, Retinal Disease
- Trial name
- NCT04246866
- Testing
- GEM103
- Where
- 12 sites in United States
- Volunteers
- 12 people
- Sponsor
- Gemini Therapeutics, Inc.
Solid Tumors With HRAS Alterations, Non Small Cell Lung Cancer (NSCLC)
KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyltransferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.
- Conditions
- Solid Tumors With HRAS Alterations, Non Small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC)
- Trial name
- FIT-001 (NCT06026410)
- Testing
- Darlifarnib, Cabozantinib, Adagrasib
- Where
- 38 sites in United States, France and 3 more
- Volunteers
- 300 people
- Sponsor
- Kura Oncology, Inc.
NSCLC (Advanced Non-small Cell Lung Cancer)
A Study to Learn the Safety and Efficacy of HLX37 in Combination With Chemotherapy for First-line Treatment in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This is a Randomized, Double-Blind, Multicenter, Phase II/III Study to Evaluate HLX37 (Recombinant Human Anti-PD-L1 and Anti-VEGF Bispecific Antibody) in Combination with Chemotherapy Versus Pembrolizumab in Combination with…
- Trial name
- NCT07865910
- Testing
- Investigational drug: HLX37 dose1, IV, Q3W, PEMBROLIZUMAB (alone or when added to a regimen above), Carboplatin (Investigator discretion)
- Where
- 16 sites in China
- Volunteers
- 1,438 people
- Sponsor
- Shanghai Henlius Biotech
Alopecia Areata
A First in Human Single and Multiple Ascending Dose and Open Label Food Effect Study of OR-101 in Healthy Subjects
This first in human phase 1 study to Study will evaluate safety, tolerability, and pharmacokinetics of Single Ascending dose (SAD), Food effect (FE) and Multiple ascending dose (MAD) of OR-101 Administered Orally in healthy…
- Trial name
- NCT06045624
- Testing
- OR-101 (Single ascending dose), OR-101 (Food effect), OR-101 (Multiple ascending dose)
- Where
- Australia
- Volunteers
- healthy volunteers welcome
- Sponsor
- Ornovi, Inc.
Healthy
This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy Subjects
The main purpose of this study is to assess the safety, tolerability and PK of AZD9742 after single IV doses.
- Trial name
- NCT01030224
- Testing
- AZD9742
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
NHL, Cutaneous T Cell Lymphoma
A Clinical Trial in Adults With Non-Hodgkin Lymphoma (NHL), With a Particular Emphasis on Cutaneous T Cell Lymphoma (CTCL), Testing the Safety and Activity of a Novel Drug to Inhibit a Protein Called Tumor Necrosis Factor Receptor 2 That Drives Both Lymphoma Growth and Escape of the Immune System
The goal of this trial is to learn if a new drug, BITR2101, works to treat non-Hodgkin lymphoma (NHL) in adults, with CTCL patients being sought in particular. The trial also seeks to learn about the safety of this drug.
- Conditions
- NHL, Cutaneous T Cell Lymphoma, Peripheral T-cell Lymphoma
- Trial name
- NCT06385522
- Testing
- BITR2101
- Volunteers
- 37 people
- Sponsor
- Boston Immune Technologies and Therapeutics
Covid19
Safety, Reactogenicity and Immunogenicity Study of ReCOV
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen that causes a coronavirus-associated acute respiratory disease called coronavirus disease 19 (COVID-19), which is spreading all over the world.
- Trial name
- NCT04818801
- Testing
- Recombinant two-component COVID-19 vaccine (CHO cell)
- Where
- 2 sites in New Zealand
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Jiangsu Rec-Biotechnology Co., Ltd.
Solid Tumors
Study in Patients With Advanced Solid Tumors to Evaluate the Safety of FTL008.16
This is an open, multi-center, multi-cohort phase I clinical study designed to evaluate safety, tolerability, pharmacokinetics and initial efficacy of FTL008.16 in patients with advanced and metastatic solid tumors.
- Trial name
- NCT06410131
- Testing
- FTL008.16
- Where
- China
- Volunteers
- 68 people
- Sponsor
- Sound Biopharmaceuticals Ltd.
Healthy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-48816274
This is a 3-part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-48816274 in healthy participants after administration of single and repeated doses, and to evaluate its potential…
- Trial name
- NCT02852395
- Testing
- JNJ-48816274
- Where
- 2 sites in United Kingdom
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Janssen-Cilag International NV
Advanced Solid Tumors
A Study of SKB518 in Patients With Advanced Solid Tumors
This is a first-in-human (FIH), phase 1, multicenter, open-label, dose-escalation study of SKB518 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic…
- Trial name
- NCT06428331
- Testing
- SKB518 for injection
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Arthritis, Rheumatoid
First-time-in-Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single (in Both Fed and Fasted States) or Repeat Doses of GSK3358699
This FTIH study, intends to identify the doses of GSK3358699, which are well tolerated by the subjects whilst delivering a robust pharmacodynamic (PD) response.
- Trial name
- NCT03426995
- Testing
- GSK3358699, GM-CSF, LPS
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline