Clinical trials: Phase 1
Frailty
A Study of Human Allogeneic Bone-marrow-derived Mesenchymal Stromal Cell Product (StromaForte) in Patients With Aging Frailty
The goal of this phase I/II clinical trial is to evaluate the safety and tolerability of intravenous infusion of human allogeneic bone-marrow-derived mesenchymal stromal cell product StromaForte in patients with aging frailty.
- Trial name
- NCT06070532
- Testing
- Human Allogeneic Bone-Marrow-Derived Mesenchymal Stromal Cell Product (StromaForte)
- Where
- The Bahamas
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Cellcolabs Clinical LTD.
Healthy
A Randomized Phase 1 of of MZE001 in Healthy Volunteers
This is a Phase 1, randomized, double-blind, placebo-controlled, single (SAD) / multiple (MAD) ascending dose and food effect study.
- Trial name
- NCT05249621
- Testing
- MZE001
- Where
- United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Maze Therapeutics
Advanced and Metastatic Breast Cancer
Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer
This dose finding/extension study was designed originally to consist of three parts: Part A was intended to identify the MTD of the AZD2014/ palbociclib combination on a background of fulvestrant (referred to as the triplet) in…
- Trial name
- PASTOR (NCT02599714)
- Testing
- AZD2014, Palbociclib, Fulvestrant
- Where
- 7 sites in United States, United Kingdom
- Volunteers
- 54 people
- Sponsor
- AstraZeneca
Alzheimer's Disease
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
- Trial name
- MINDSET 1 (NCT06976216)
- Testing
- KarXT, KarX-EC
- Where
- 119 sites in United States, Argentina and 17 more
- Volunteers
- 586 people
- Sponsor
- Bristol-Myers Squibb
Cancer, Mesothelin-positive
A Study of MORAb-009 in Patients With Solid Tumor
MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.
- Trial name
- NCT01018784
- Testing
- MORAb-009
- Where
- Japan
- Volunteers
- 17 people
- Sponsor
- Eisai Co., Ltd.
Chronic Obstructive Pulmonary Disease
A Study to Assess Safety, Tolerability and Pharmacokinetics of of AZD6553 in Healthy Volunteers and Patients With Chronic Obstructive Pulmonary Disease (COPD)
AZD6553 is a new drug being developed as a possible treatment for patients with chronic obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the…
- Trial name
- NCT01068184
- Testing
- AZD6553
- Where
- United Kingdom
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Amyotrophic Lateral Sclerosis
To Determine the Maximum Tolerated Dose (MTD) of HK-001 in Healthy Volunteers
Eligible subjects will receive either different dosages of HK-001 or placebo in a 3:1 ratio in 1 of the 7 dose cohorts. After single dose administration, followed by an independent Data and Safety Monitoring Board (DSMB) meeting…
- Trial name
- NCT03651349
- Testing
- HK-001
- Where
- Taiwan
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Everfront Biotech Co., Ltd.
Spinocerebellar Ataxias, Spinocerebellar Ataxia Genotype Type 1
Trial in Adult Participants With Spinocerebellar Ataxia (SCA)
The primary purpose of this study was to compare the efficacy of BHV-4157 (Troriluzole) 140 milligrams (mg) once daily versus placebo after 8 weeks of treatment in participants with spinocerebellar ataxia (SCA).
- Conditions
- Spinocerebellar Ataxias, Spinocerebellar Ataxia Genotype Type 1, Spinocerebellar Ataxia Genotype Type 2, Spinocerebellar Ataxia Genotype Type 3
- Trial name
- NCT02960893
- Testing
- Troriluzole
- Where
- 18 sites in United States
- Volunteers
- 141 people
- Sponsor
- Biohaven Pharmaceuticals, Inc.
Multiple Myeloma
First in Human Dose Escalation of M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone
The purpose of this study was to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and early efficacy signs of M3258 as a single agent and co-administered with dexamethasone in participants with Relapsed…
- Trial name
- NCT04075721
- Testing
- M3258, M3258 20 mg
- Where
- 7 sites in United States, France
- Volunteers
- 10 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Solid Tumor, Small Cell and Non-small Cell Lung Cancer
RAPA-201 Therapy of Solid Tumors
The therapy of solid tumors has been revolutionized by immune therapy, in particular, approaches that activate immune T cells in a polyclonal manner through blockade of checkpoint pathways such as PD-1 by administration of…
- Conditions
- Solid Tumor, Small Cell and Non-small Cell Lung Cancer, Head and Neck Cancer, Squamous Cell Carcinoma of Oral Cavity
- Trial name
- NCT05144698
- Testing
- RAPA-201 Rapamycin Resistant T Cells, Chemotherapy Prior to RAPA-201 Therapy, Pembrolizumab (PD-1 Blocking Antibody)
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Rapa Therapeutics LLC
Acne Vulgaris
A Phase 1, 3 Day Study of Safety and Tolerability of NVN1000 Topical Gel in Healthy Volunteers
A Phase I, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers
- Trial name
- NCT01755247
- Testing
- Topical Gel Vehicle, 8% NVN1000 Topical Gel, 8% NVN1000 Topical Gel and moisturizer
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Novan, Inc.
Advanced Solid Tumors
SKB118 Injection in Advanced Solid Tumors
This is a multicenter, open-label, Phase I/II clinical study. The study is divided into two parts, the SKB118 monotherapy study and the SKB118 in combination with SKB264 study.
- Trial name
- NCT07586943
- Testing
- SKB118 Injection, SKB118+SKB264
- Where
- China
- Volunteers
- 530 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Acne Vulgaris
A Safety, Tolerability, Efficacy and Exposure Study of XEN801 Topical Gel
Phase 1/2 study enrolling up to 60 healthy volunteers in Phase 1 followed by approximately 150 subjects with acne vulgaris in Phase 2.
- Trial name
- NCT02656043
- Testing
- XPF-005
- Where
- 20 sites in Canada
- Volunteers
- 213 people, healthy volunteers welcome
- Sponsor
- Xenon Pharmaceuticals Inc.
Carcinoma, Non-Small-Cell Lung
A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer
The main purpose of this study is to find out the most suitable dose (recommended phase 2 combination dose [RP2CD]) of amivantamab and olomorasib combination therapy and to assess how well the combination slows down or prevents…
- Trial name
- KaRAnaSa (NCT07227025)
- Testing
- Amivantamab, Olomorasib
- Where
- 12 sites in United States, Canada and 3 more
- Volunteers
- 60 people
- Sponsor
- Janssen Research & Development, LLC
Colorectal Cancer, Metastatic Colorectal Adenocarcinoma
Dual-Targeting CAR-NK Cells in Biomarker-Selected Advanced Colorectal Cancer
This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of an allogeneic dual-target chimeric antigen receptor natural killer (CAR-NK) cell product in adults with advanced or metastatic…
- Conditions
- Colorectal Cancer, Metastatic Colorectal Adenocarcinoma, Unresectable Colorectal Cancer
- Trial name
- DUO-CRC-NK-111 (NCT07589517)
- Testing
- EB-DUO-CAR-NK-CEA/GCC, Lymphodepletion
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Beijing Biotech
Solid Tumor, Adult, Advanced Solid Tumors
IMX-110 in Patients With Advanced Solid Tumors
Phase 1 is an open-label, multi-center dose escalation/dose expansion study designed to assess the safety, tolerability and pharmacokinetics (PK) for the recommended phase 2 dose (RP2D) of IMX-110.
- Conditions
- Solid Tumor, Adult, Advanced Solid Tumors, Pancreatic Cancer, Breast Cancer
- Trial name
- NCT03382340
- Testing
- Imx-110
- Where
- 2 sites in United States, Australia
- Volunteers
- 70 people
- Sponsor
- Immix Biopharma Australia Pty Ltd
Indolent B-Cell Non-Hodgkin Lymphoma
A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory…
- Trial name
- NCT03571568
- Testing
- BI-1206, Rituximab, Acalabrutinib
- Where
- 27 sites in United States, Brazil and 4 more
- Volunteers
- 140 people
- Sponsor
- BioInvent International AB
Bacterial Infections.
A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.
A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients aged 3 months to 11 years (inclusive) following the intravenous administration of a single dose of dalbavancin.
- Trial name
- NCT01946568
- Testing
- Dalbavancin
- Where
- 12 sites in United States, Estonia
- Volunteers
- 36 people
- Sponsor
- Durata Therapeutics Inc., an affiliate of Allergan plc
Infections, Meningococcal
The Long-term Antibody Persistence of MenACWY-TT Vaccine (PF-06866681) Versus Meningitec(Registered) or Mencevax(Registered) ACWY in Healthy Adolescents and Adults and a Booster Dose of MenACWY-TT Administered 10 Years Post Primary Vaccination
The purpose of this study is to evaluate the long-term antibody persistence 6, 7, 8, 9 and 10 years after receiving a primary vaccination of meningococcal conjugate vaccine MenACWY-TT versus Meningitec™ or Mencevax™ ACWY, and the…
- Trial name
- NCT01962207
- Testing
- Meningococcal vaccine GSK134612
- Where
- 9 sites in Finland
- Volunteers
- 243 people, healthy volunteers welcome
- Sponsor
- Pfizer
Group B Streptococcal Infections
Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.
To assess the safety and tolerability of IVT GBS-06 vaccine administered as a single-dose regimen, at three dosage levels in healthy, non-pregnant, adult women of childbearing age (WOCBA).
- Trial name
- NCT06611371
- Testing
- IVT GBS-06
- Where
- 2 sites in United States, South Africa
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Inventprise Inc.