Clinical trials: Dose Escalation and Safety, active
Spasticity
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
The purpose of the study is to assess the safety and efficacy of increasing doses of Corabotase (also known as IPN10200) with the aim to evaluate the Pharmacodynamics (PD) profile of Corabotase and to establish the total…
- Trial name
- LANTIMA (NCT04752774)
- Testing
- Corabotase, Dysport
- Where
- 81 sites in United States, Austria and 12 more
- Volunteers
- 240 people
- Sponsor
- Ipsen
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.
- Trial name
- NCT06745297
- Testing
- BI 3776528, short-acting benzodiazepine
- Where
- Germany
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Type 1 Diabetes, Type 1 Diabetes (T1D)
Study of IMC-S118AI in Type 1 Diabetes
This is a first-in-human (FIH) study designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of IMC-S118AI in single-ascending dose (SAD) and multiple-ascending dose (MAD) regimens.
- Conditions
- Type 1 Diabetes, Type 1 Diabetes (T1D), Diabetes Type 1
- Trial name
- NCT07493122
- Testing
- IMC-S118AI
- Volunteers
- 154 people
- Sponsor
- Immunocore Ltd
Inherited Retinal Diseases
Safety and Efficacy Study of PUMCH-E101 Injection in Subjects with RDH12 Retinopathy
The goal of this clinical trial is to evaluate the safety and efficacy of PUMCH-E101 injection in subjects with RDH12 retinopathy.
- Trial name
- NCT06749639
- Testing
- PUMCH-E101 Injection（Low dose）, PUMCH-E101 Injection（High dose）
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Peking Union Medical College Hospital
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KL0011034 Injection in Healthy Volunteers
To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single intravenous doses of KL0011034 injection in healthy volunteers.
- Trial name
- NCT07474545
- Testing
- KL0011034 injection, Etomidate Injectable Emulsion
- Where
- China
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Hunan Kelun Pharmaceutical Co., Ltd.
Huntington Disease
A Randomized Study of SPK-10001 Gene Therapy in Participants With Huntington's Disease
The main goal of this study is to evaluate the safety, tolerability, and preliminary efficacy of SPK-10001 in participants with Huntington's Disease.
- Trial name
- NCT06826612
- Testing
- SPK-10001
- Where
- 5 sites in United States
- Volunteers
- 53 people
- Sponsor
- Hoffmann-La Roche
Advanced Solid Tumor
A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Efficacy of SGT003 in Patients With Advanced Solid Tumors
A Phase I/IIa clinical study SGT003 in patients with advanced solid tumors.
- Trial name
- NCT07811037
- Testing
- SGT003
- Where
- China
- Volunteers
- 332 people
- Sponsor
- Beijing Sungen Biomedical Technology Co., Ltd
Recurrent High Grade Gliomas, Glioblastoma (GBM)
A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)
ALERT-1 is a Phase 1/2 study evaluating the safety and preliminary anti-tumor activity of SRN-101, an investigational gene therapy, in adults with recurrent high-grade glioma. High-grade glioma is a type of brain cancer.
- Conditions
- Recurrent High Grade Gliomas, Glioblastoma (GBM), Astrocytoma, Oligodendroglioma
- Trial name
- ALERT-1 (NCT07902037)
- Testing
- SRN-101
- Volunteers
- 40 people
- Sponsor
- Siren Biotechnology
Gastric Cancer, Gastroesophageal Junction Cancer
Study for AZD4360 in Participants With Advanced Solid Tumours
The purpose of this study is to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD4360 in adult participants with locally advanced or metastatic solid tumours selected for…
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer, Biliary Tract Cancer, Pancreatic Ductal Adenocarcinoma
- Trial name
- NCT06921928
- Testing
- AZD4360
- Where
- 14 sites in United States, China and 3 more
- Volunteers
- 31 people
- Sponsor
- AstraZeneca
Advanced or Recurrent Solid Tumors
EVM16 Injection as a Single and Combination With Tislelizumab in Solid Tumors
The goal of this clinical trial is to learn the side effects, safety and effect of a tumor vaccine (EVM16) alone or in combined with an anti-PD-1 antibody (tislelizumab) .
- Trial name
- NCT06541639
- Testing
- EVM16, Tislelizumab
- Where
- 2 sites in China
- Volunteers
- 78 people
- Sponsor
- Peking University
Breast Cancer
A Phase I/II Trial to Evaluate Oral HP568 Tablets in Patients with ER+/HER2 Advanced Breast Cancer
This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and preliminary efficacy of HP568 alone and in combination with palbociclib in patients with ER+/HER2- locally advanced or…
- Trial name
- NCT06757335
- Testing
- HP568, HP568 in combination with palbociclib
- Volunteers
- 204 people
- Sponsor
- Hinova Pharmaceuticals Inc.
X-Linked Retinitis Pigmentosa
Safety and Efficacy of rAAV2tYF-GRK1-RPGR in Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations
This study will evaluate the safety and efficacy of a recombinant adeno-associated virus vector (rAAV2tYF-GRK1-RPGR) in patients with X-linked retinitis pigmentosa caused by RPGR mutations.
- Trial name
- HORIZON (NCT03316560)
- Testing
- rAAV2tYF-GRK1-RPGR
- Where
- 4 sites in United States
- Volunteers
- 29 people
- Sponsor
- Beacon Therapeutics
Healthy Volunteers
Study of HX15001 in Adult Healthy Volunteers.
This is a phase I, randomized, double-blinded, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HX15001 in adult healthy…
- Trial name
- NCT06999720
- Testing
- HX15001 (SAD), HX15001 (MAD)
- Where
- Australia
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Helixon Biotechnology (Suzhou) Co., Ltd
Solid Tumors
A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
This study will evaluate the safety, tolerability, and pharmacokinetics of Runimotamab administered intravenously as a single agent and in combination with Trastuzumab in participants with locally advanced or metastatic Human…
- Trial name
- NCT03448042
- Testing
- Runimotamab, Trastuzumab, Tocilizumab
- Where
- 26 sites in United States, Australia and 11 more
- Volunteers
- 123 people
- Sponsor
- Genentech, Inc.
Relapsed or Resistant Acute Leukaemias
The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias
The most common types of acute leukaemia are acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML). AML is a heterogenous clonal disorder of haemopoietic progenitor cells and the most common and severe malignant…
- Trial name
- NCT05756322
- Testing
- LBS-007
- Where
- 17 sites in United States, Australia and 2 more
- Volunteers
- 90 people
- Sponsor
- Lin BioScience, Inc
Advanced Cancer, Metastatic Cancer
FS222 First in Human Study in Patients With Advanced Malignancies
This study will be conducted in adult participants diagnosed with advanced tumours to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS222.
- Trial name
- NCT04740424
- Testing
- FS222
- Where
- 21 sites in Australia, Georgia and 5 more
- Volunteers
- 260 people
- Sponsor
- invoX Pharma Limited
Advanced Malignancies
A Phase 1 Study of HCB303 in Participants With Advanced Malignancies
A Phase 1, Open-label, Multi-regional, Multicenter, Dose escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Antitumor Activity of HCB303 in Participants with…
- Trial name
- NCT07859228
- Testing
- HCB303
- Volunteers
- 150 people
- Sponsor
- FBD Biologics Limited
Solid Tumors, Adult
PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Solid Tumors
A single-center, single-arm, dose-escalation exploratory clinical trial on the safety and efficacy of PANK-003 cell injection(Peripheral blood-derived allogeneic natural killer cells )combined with standard adjuvant chemotherapy…
- Trial name
- NCT06897228
- Testing
- PANK-003 cell injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Shenzhen Celconta Life Science Co., Ltd.
Ovarian Cancer, Squamous Non-Small Cell Lung Cancer (NSCLC)
A Study to Test the Safety, Tolerability and Effect of ZI-MA4-1 for Patients With Locally Advanced or Metastatic Solid Malignancies
This study will recruit patients with the following cancer indications: ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma and head and neck cancer, with inoperable locally advanced or metastatic solid tumours.
- Conditions
- Ovarian Cancer, Squamous Non-Small Cell Lung Cancer (NSCLC), Synovial Sarcomas, Head and Neck Cancer
- Trial name
- NCT07613723
- Testing
- ZI-MA4-1 (TCR-NK cells), Cyclophosphamide, Fludarabine
- Where
- 2 sites in United Kingdom
- Volunteers
- 9 people
- Sponsor
- Zelluna Immunotherapy AS
Solid Tumors
A Study to Investigate Safety and Preliminary Efficacy of SOA101 in Adult Subjects With Advanced Solid Tumors
The investigational drug, SOA101, is a nanobody-based trispecific antibody T cell engager targeting PD-L1/HLA-G/CD3. This is a Phase I/IIa study including dose-escalation, dose optimization and dose expansion parts to exam…
- Trial name
- NbTAST-01 (NCT07055594)
- Testing
- SOA101
- Where
- Taiwan
- Volunteers
- 76 people
- Sponsor
- Shine-On Biomedical Co., Ltd.